To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada)

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00754065
• Collaborator: (none)
• Enrollment: 409
• Locations: 59
• Arms: 2
• Duration (Months): 31.9
• Patients Per Site: 6.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The objective of the study is to compare the oral contraceptive (OC) SH T00658ID over Ortho Tri-Cyclen Lo administered for 13 cycles to healthy female volunteers between 18 and 50 years of age who request oral contraceptive protection. Subjects on a levonorgestrel (LNG), norgestimate (NGM), norethindrone or norethindrone acetate containing oral contraceptive in a 21-day regimen suffering from hormone withdrawal-associated symptoms such as pelvic pain or headache or both, and willing to continue OC use but to switch to SH T00658ID or Ortho Tri-Cyclen Lo.

Condition or Disease	Intervention/Treatment	Phase
Contraception	Drug: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027); Drug: Ortho Tri Cyclen Lo	Phase 3

Detailed Description

Safety issues are addressed in the Adverse Events section.

Study Design

• Study Type: Interventional
• Actual Enrollment: 409 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, 2-arm Study to Show Superiority of the Oral Contraceptive SH T00658ID Over Ortho Tri-Cyclen Lo on Hormone Withdrawal-associated Symptoms After 6 Cycles of Treatment.
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Drug: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027); Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one encapsulated BAY86-5027 for 28 days per Cycle, for 13 treatment cycles: Days 1-2, 3.0 mg EV; Days 3-7, 2.0 mg EV+2.0 mg DNG; Days 8-24, 2.0 mg EV+3.0 mg DNG; Days 25-26, 1.0 mg EV; Days 27-28, placebo
Active Comparator: Ortho Tri-Cyclen Lo Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Drug: Ortho Tri Cyclen Lo; Dose--Ethinylestradiol (EE) + Norgestimate (NGM) Triphasic 21-day regimen. Daily oral administration of one encapsulated Ortho Tri-Cyclen Lo for 28 days per Cycle, for 13 treatment cycles: Days 1-7, 0.025 mg EE+0.180 NGM; Days 8-14, 0.025 mg EE+0.215 NGM; Days 15-21, 0.025 mg EE+0.250 NGM; Days 27-28, placebo

Outcome Measures

Primary Outcome Measures

1. The Change in Average of the 3 Highest Visual Analog Scale (VAS) Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28 From Baseline to Cycle 6 [Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)]

   Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).

Secondary Outcome Measures

1. The Change From Baseline to Cycle 6 in the Number of Ibuprofen Tablets Used as Rescue Medication [From Baseline to Cycle 6 (28 days per Cycle)]

   Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 6th treatment cycle until Day 28 of the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation (SD) derived.

2. The Change From Baseline to Cycle 13 in the Number of Ibuprofen Tablets Used as Rescue Medication [From Baseline to Cycle 13 (28 days per Cycle)]

   Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 13th treatment cycle until Day 28 before the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation ((SD) derived.

3. Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28 [Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)]

   Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 22-28. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 22-28 before 1st menstrual bleeding (normalized to a 7-day period). Treatment period: cycle Days 22-28 before WB of 6th treatment cycle until (normalized to a 7-day period). Score difference min -7 (best), max 7 (worst).

4. Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28 [Day 22-28 from Baseline to Day 22-28 from Cycle 13 (28 days per Cycle)]

   Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 22-28. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 22-28 before 1st menstrual bleeding (normalized to a 7-day period). Treatment period: cycle Days 22-28 before WB of 13th treatment cycle (normalized to a 7-day period). Score difference min -7 (best), max 7 (worst).

5. Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21 [Day 1-21 from Baseline to Day 1-21 from Cycle 6 (28 days per Cycle)]

   Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 1-21. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 1-21 before 1st menstrual bleeding (normalized to a 21-day period). Treatment period: cycle Days 1-21 before WB of 6th treatment cycle (normalized to a 21-day period). Score difference min -21 (best), max 21 (worst).

6. Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21 [Day 1-21 from Baseline to Day 1-21 from Cycle 13 (28 days per Cycle)]

   Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 1-21. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 1-21 before 1st menstrual bleeding (normalized to a 21-day period). Treatment period: cycle Days 1-21 before WB of 13th treatment cycle (normalized to a 21-day period). Score difference min -21 (best), max 21 (worst).

7. Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM [From Baseline to Cycle 6 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle)]

   Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode (cycle Days 22-28). Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Score difference min -2 (best), max 2 (worst) for the estradiol valerate (EV)/dienogest (DNG) group and min -7 (best), max 7 (worst) for the ethinylestradiol (EE)/norgestimate (NGM) group.

8. Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM [From Baseline to Cycle 13 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle)]

   Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode (cycle Days 22-28). Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Score difference min -2 (best), max 2 (worst) for the EV/DNG group and min -7 (best), max 7 (worst) for the EE/NGM group.

9. Change From Baseline to Cycle 3 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28 [Days 22-28 from Baseline to Days 22-28 from Cycle 3 (28 days per Cycle)]

   Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).

10. Change From Baseline to Cycle 13 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28 [Days 22-28 from Baseline to Days 22-28 from Cycle 13 (28 days per Cycle)]

    Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).

11. Number of Days With Bleeding or Spotting in Reference Period 1 [From Day 1 to Day 90]

    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

12. Number of Days With Bleeding or Spotting in Reference Period 2 [From Day 91 to Day 180]

    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

13. Number of Days With Bleeding or Spotting in Reference Period 3 [From Day 181 to Day 270]

    Reference Period 3 is defined as Day 181 to Day 270 during study treatment.

14. Number of Days With Bleeding or Spotting in Reference Period 4 [From Day 271 to Day 360]

    Reference Period 4 is defined as Day 271 to Day 360 during study treatment.

15. Number of Bleeding / Spotting Episodes in Reference Period 1 [From Day 1 to Day 90]

    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. (Episode is a set of days with bleeding/spotting)

16. Number of Bleeding / Spotting Episodes in Reference Period 2 [From Day 91 to Day 180]

    Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (Episode is a set of days with bleeding/spotting)

17. Number of Bleeding / Spotting Episodes in Reference Period 3 [From Day 181 to Day 270]

    Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (Episode is a set of days with bleeding/spotting)

18. Number of Bleeding / Spotting Episodes in Reference Period 4 [From Day 271 to Day 360]

    Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (Episode is a set of days with bleeding/spotting)

19. Mean Length of Bleeding / Spotting Episodes in Reference Period 1 [From Day 1 to Day 90]

    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

20. Mean Length of Bleeding / Spotting Episodes in Reference Period 2 [From Day 91 to Day 180]

    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

21. Mean Length of Bleeding / Spotting Episodes in Reference Period 3 [From Day 181 to Day 270]

    Reference Period 3 is defined as Day 181 to Day 270 during study treatment.

22. Mean Length of Bleeding / Spotting Episodes in Reference Period 4 [From Day 271 to Day 360]

    Reference Period 4 is defined as Day 271 to Day 360 during study treatment.

23. Maximum Length of Bleeding / Spotting Episodes in Reference Period 1 [From Day 1 to Day 90]

    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

24. Maximum Length of Bleeding / Spotting Episodes in Reference Period 2 [From Day 91 to Day 180]

    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

25. Maximum Length of Bleeding / Spotting Episodes in Reference Period 3 [From Day 181 to Day 270]

    Reference Period 3 is defined as Day 181 to Day 270 during study treatment.

26. Maximum Length of Bleeding / Spotting Episodes in Reference Period 4 [From Day 271 to Day 360]

    Reference Period 4 is defined as Day 271 to Day 360 during study treatment.

27. Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1 [From Day 1 to Day 90]

    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

28. Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2 [From Day 91 to Day 180]

    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

29. Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 3 [From Day 181 to Day 270]

    Reference Period 3 is defined as Day 181 to Day 270 during study treatment.

30. Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 4 [From Day 271 to Day 360]

    Reference Period 4 is defined as Day 271 to Day 360 during study treatment.

31. Number of Days With Spotting-only in Reference Period 1 [From Day 1 to Day 90]

    Reference Period 1 is defined as Day 1 to Day 90 during study treatment.

32. Number of Days With Spotting-only in Reference Period 2 [From Day 91 to Day 180]

    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

33. Number of Days With Spotting-only in Reference Period 3 [From Day 181 to Day 270]

    Reference Period 3 is defined as Day 181 to Day 270 during study treatment.

34. Number of Days With Spotting-only in Reference Period 4 [From Day 271 to Day 360]

    Reference Period 4 is defined as Day 271 to Day 360 during study treatment.

35. Number of Spotting-only Episodes in Reference Period 1 [From Day 1 to Day 90]

    Reference Period 1 is defined as Day 1 to Day 90 during study treatment.

36. Number of Spotting-only Episodes in Reference Period 2 [From Day 91 to Day 180]

    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

37. Number of Spotting-only Episodes in Reference Period 3 [From Day 181 to Day 270]

    Reference Period 3 is defined as Day 181 to Day 270 during study treatment.

38. Number of Spotting-only Episodes in Reference Period 4 [From Day 271 to Day 360]

    Reference Period 4 is defined as Day 271 to Day 360 during study treatment.

39. Mean Length of Spotting-only Episodes in Reference Period 1 [From Day 1 to Day 90]

    Reference Period 1 is defined as Day 1 to Day 90 during study treatment.

40. Mean Length of Spotting-only Episodes in Reference Period 2 [From Day 91 to Day 180]

    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

41. Mean Length of Spotting-only Episodes in Reference Period 3 [From Day 181 to Day 270]

    Reference Period 3 is defined as Day 181 to Day 270 during study treatment.

42. Mean Length of Spotting-only Episodes in Reference Period 4 [From Day 271 to Day 360]

    Reference Period 4 is defined as Day 271 to Day 360 during study treatment.

43. Maximum Length of Spotting-only Episodes in Reference Period 1 [From Day 1 to Day 90]

    Reference Period 1 is defined as Day 1 to Day 90 during study treatment.

44. Maximum Length of Spotting-only Episodes in Reference Period 2 [From Day 91 to Day 180]

    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

45. Maximum Length of Spotting-only Episodes in Reference Period 3 [From Day 181 to Day 270]

    Reference Period 3 is defined as Day 181 to Day 270 during study treatment.

46. Maximum Length of Spotting-only Episodes in Reference Period 4 [From Day 271 to Day 360]

    Reference Period 4 is defined as Day 271 to Day 360 during study treatment.

47. Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1 [From Day 1 to Day 90]

    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

48. Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2 [From Day 91 to Day 180]

    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

49. Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 3 [From Day 181 to Day 270]

    Reference Period 3 is defined as Day 181 to Day 270 during study treatment.

50. Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 4 [From Day 271 to Day 360]

    Reference Period 4 is defined as Day 271 to Day 360 during study treatment.

51. Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1 [At Cycle 1 (28 days per Cycle)]

    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.

52. Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3 [At Cycle 3 (28 days per Cycle)]

    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.

53. Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6 [At Cycle 6 (28 days per Cycle)]

    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.

54. Percentage of Participants With / Without Withdrawal Bleeding at Cycle 13 [At Cycle 13 (28 days per Cycle)]

    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.

55. Length of Withdrawal Bleeding Episodes at Cycle 1 [At Cycle 1 (28 days per Cycle)]

    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.

56. Length of Withdrawal Bleeding Episodes at Cycle 3 [At Cycle 3 (28 days per Cycle)]

    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.

57. Length of Withdrawal Bleeding Episodes at Cycle 6 [At Cycle 6 (28 days per Cycle)]

    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.

58. Length of Withdrawal Bleeding Episodes at Cycle 13 [At Cycle 13 (28 days per Cycle)]

    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.

59. Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1 [At Cycle 1 (28 days per Cycle)]

    Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.

60. Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3 [At Cycle 3 (28 days per Cycle)]

    Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.

61. Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6 [At Cycle 6 (28 days per Cycle)]

    Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.

62. Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 13 [At Cycle 13 (28 days per Cycle)]

    Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.

63. Onset of Withdrawal Bleeding Episodes at Cycle 1 [At Cycle 1 (28 days per Cycle)]

    Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).

64. Onset of Withdrawal Bleeding Episodes at Cycle 3 [At Cycle 3 (28 days per Cycle)]

    Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).

65. Onset of Withdrawal Bleeding Episodes at Cycle 6 [At Cycle 6 (28 days per Cycle)]

    Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).

66. Onset of Withdrawal Bleeding Episodes at Cycle 13 [At Cycle 13 (28 days per Cycle)]

    Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).

67. Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1 [At Cycle 1 (28 days per Cycle)]

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

68. Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3 [At Cycle 3 (28 days per Cycle)]

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

69. Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6 [At Cycle 6 (28 days per Cycle)]

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

70. Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 13 [At Cycle 13 (28 days per Cycle)]

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

71. Number of Intracyclic Bleeding Episodes at Cycle 1 [At Cycle 1 (28 days per Cycle)]

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)

72. Number of Intracyclic Bleeding Episodes at Cycle 3 [At Cycle 3 (28 days per Cycle)]

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)

73. Number of Intracyclic Bleeding Episodes at Cycle 6 [At Cycle 6 (28 days per Cycle)]

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)

74. Number of Intracyclic Bleeding Episodes at Cycle 13 [At Cycle 13 (28 days per Cycle)]

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)

75. Maximum Length of Intracyclic Bleeding Episodes at Cycle 1 [At Cycle 1 (28 days per Cycle)]

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

76. Maximum Length of Intracyclic Bleeding Episodes at Cycle 3 [At Cycle 3 (28 days per Cycle)]

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

77. Maximum Length of Intracyclic Bleeding Episodes at Cycle 6 [At Cycle 6 (28 days per Cycle)]

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

78. Maximum Length of Intracyclic Bleeding Episodes at Cycle 13 [At Cycle 13 (28 days per Cycle)]

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

79. Number of Intracyclic Bleeding Days at Cycle 1 [At Cycle 1 (28 days per Cycle)]

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

80. Number of Intracyclic Bleeding Days at Cycle 3 [At Cycle 3 (28 days per Cycle)]

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

81. Number of Intracyclic Bleeding Days at Cycle 6 [At Cycle 6 (28 days per Cycle)]

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

82. Number of Intracyclic Bleeding Days at Cycle 13 [At Cycle 13 (28 days per Cycle)]

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

83. Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1 [At Cycle 1 (28 days per Cycle)]

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.

84. Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3 [At Cycle 3 (28 days per Cycle)]

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.

85. Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6 [At Cycle 6 (28 days per Cycle)]

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.

86. Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 13 [At Cycle 13 (28 days per Cycle)]

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.

87. Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 6 [Cycles 2 to 6 (28 days per Cycle)]

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

88. Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 13 [Cycles 2 to 13 (28 days per Cycle)]

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

89. Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) [Baseline up to Cycle 6 (28 days per Cycle)]

    Change from Baseline to Cycle 6 in PGWBI Questionnaire's assessment of participant's overall sense of well-being or distress. The PGWBI includes 22 items that, apart from combining into a global overall score, are divided into 6 dimensions: anxiety, depressed mood, positive well-being, self-control, health, and vitality. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score as well as all the sub-domains score ranges from -100 (worst) to 100 (best).

90. Mean Change From Baseline to Cycle 13 in Psychological General Well-Being Index (PGWBI) [Baseline up to Cycle 13 (28 days per Cycle)]

    Change from Baseline to Cycle 13 in PGWBI Questionnaire's assessment of participant's overall sense of well-being or distress. The PGWBI includes 22 items that, apart from combining into a global overall score, are divided into 6 dimensions: anxiety, depressed mood, positive well-being, self-control, health, and vitality. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score as well as all the sub-domains score ranges from -100 (worst) to 100 (best).

91. Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Physical Health [Baseline up to Cycle 6 (28 days per Cycle)]

    Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (physical health - 13 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

92. Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Physical Health [Baseline up to Cycle 13 (28 days per Cycle)]

    Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (physical health - 13 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

93. Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Participant Feeling [Baseline up to Cycle 6 (28 days per Cycle)]

    Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (participant feeling - 14 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

94. Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Participant Feeling [Baseline up to Cycle 13 (28 days per Cycle)]

    Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (participant feeling - 14 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

95. Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Work [Baseline up to Cycle 6 (28 days per Cycle)]

    Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (work - yes or no; if yes, then 4 choices, and 13 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

96. Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Work [Baseline up to Cycle 13 (28 days per Cycle)]

    Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (work - yes or no; if yes, then 4 choices, and 13 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

97. Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Household Duties [Baseline up to Cycle 6 (28 days per Cycle)]

    Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (household duties - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

98. Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Household Duties [Baseline up to Cycle 13 (28 days per Cycle)]

    Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (household duties - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

99. Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - School/Course Work [Baseline up to Cycle 6 (28 days per Cycle)]

    Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (school / course work - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

100. Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - School/Course Work [Baseline up to Cycle 13 (28 days per Cycle)]

     Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (school / course work - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

101. Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Leisure Time Activities [Baseline up to Cycle 6 (28 days per Cycle)]

     Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (leisure time activities - 6 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

102. Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Leisure Time Activities [Baseline up to Cycle 13 (28 days per Cycle)]

     Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (leisure time activities - 6 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

103. Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Social Relationship [Baseline up to Cycle 6 (28 days per Cycle)]

     Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (social relationship - 11 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

104. Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Social Relationship [Baseline up to Cycle 13 (28 days per Cycle)]

     Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (social relationship - 11 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

105. Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - General Activities [Baseline up to Cycle 6 (28 days per Cycle)]

     Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (general activities - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

106. Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - General Activities [Baseline up to Cycle 13 (28 days per Cycle)]

     Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (general activities - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

107. Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Item Satisfaction [Baseline up to Cycle 6 (28 days per Cycle)]

     Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (item satisfaction). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

108. Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Item Satisfaction [Baseline up to Cycle 13 (28 days per Cycle)]

     Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (item satisfaction). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

109. Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Overall Life Satisfaction and Contentment [Baseline up to Cycle 6 (28 days per Cycle)]

     Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (overall life satisfaction and contentment). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

110. Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Overall Life Satisfaction and Contentment [Baseline up to Cycle 13 (28 days per Cycle)]

     Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (overall life satisfaction and contentment). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

111. Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6 [At Cycle 6 (28 days per Cycle)]

     CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.

112. Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 13 [At Cycle 13 (28 days per Cycle)]

     CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.

113. Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6 [At Cycle 6 (28 days per Cycle)]

     In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.

114. Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 13 [At Cycle 13 (28 days per Cycle)]

     In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.

Other Outcome Measures

1. Percentage of Participants With no Increase in Rescue Medication and VAS Decrease During Cycle Days 22 to 28 From Baseline to Cycle 6 [Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)]

   Rescue medication was standardized intake of 200 mg Ibuprofen tablets. Baseline: 7 days (Day 22) before first menstrual bleeding to Day 28. Treatment: 7 days (Day 22) before withdrawal bleeding of 6th cycle to Day 28 before the same cycle. The visual analog scale (VAS) is a subject-assessed measure of pelvic pain or headache consisting of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).

2. The Change of Pelvic Pain or Headache as Determined by the Highest Visual Analog Scale (VAS) Values During Cycle Days 22 to 28 From Baseline to Cycle 6 [Days 22-28 from Baseline to Days 22-28 from Cycle 6 (28 days per Cycle)]

   Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Signed and dated informed consent

• Age between 18 and 50 years (inclusive), smokers maximum age of 35 years (inclusive) at Visit 1

• Otherwise healthy female subjects requesting contraception and currently using a LNG, NGM, or norethindrone/norethindrone acetate containing OC in a 21-day regimen and suffering from at least moderate pelvic pain, headache or both defined by an average of the highest 3 values of >/=35 mm on a VAS during cycle days 22-28 (35 mm VAS is the expected standard deviation of the population VAS reduction)

• Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the last 6 months before screening) Women with atypical squamous cell of undetermined significance (ASCUS) can be included if they have a negative human papilloma virus (HPV) test result. The laboratory will perform an HPV test if the Pap smear result is ASCUS.

• Able to tolerate ibuprofen and willing to use only ibuprofen supplied by the investigator

Exclusion Criteria:

• Pregnancy or lactation (less than three cycles since delivery, abortion, or lactation before start of treatment)

• Body mass index (BMI) >32 kg/m2

• Hypersensitivity to any of the study drug ingredients

• Individuals not willing to consume pork and beef products. Women may be included if they are willing to take the capsules

• Safety relevant laboratory values, provided by the central laboratory, outside inclusion range before start of treatment

• Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication (such as but not limited to duodenal ulcers, gastritis, gastrectomy or gastric resection surgery, or renal compromise)

• Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results

• Any disease or condition that may worsen under hormonal treatment

• Undiagnosed abnormal genital bleeding

• Abuse of alcohol, drugs, or medicines (eg, laxatives)

• Other contraceptive methods

• Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results

• Simultaneous participation in another clinical trial prior to study entry that might have an impact on the study objectives at the discretion of the investigator

• Major surgery scheduled for the study period

• Subject is a dependent person, eg: a family member or member of the Investigator's staff

• Inability to cooperate with the study procedures for any reason, including language comprehension, psychiatric illness, inability to get to the study site

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Precision Trials, LLC	Glendale	Arizona	United States	85304
2	Precision Trials	Phoenix	Arizona	United States	85032
3	Pacific Coast Research Center Inc.	Encinitas	California	United States	92024
4	Medical Center for Clinical Research	San Diego	California	United States	92108
5	Blue Hill Medical Group	Santa Monica	California	United States	90404
6	Cherry Creek Family Practice	Denver	Colorado	United States	80206
7	Downtown Women's Healthcare	Denver	Colorado	United States	80218
8	Altitude Family Medicine, PC	Littleton	Colorado	United States	80127
9	Women's Medical Research Group, LLC	Clearwater	Florida	United States	33759
10	University of Florida College of Medicine	Jacksonville	Florida	United States	32207
11	Comprehensive Clinical Trials	West Palm Beach	Florida	United States	33409
12	Soapstone Center for Clinical Research	Decatur	Georgia	United States	30034
13	Women's Health Associates	Boise	Idaho	United States	83702
14	The Women's Clinic	Boise	Idaho	United States	83712
15	Rosemark Clinical Research	Idaho Falls	Idaho	United States	83406
16	Internal Medicine and Pediatrics	Fishers	Indiana	United States	46037
17	First Care Family Medicine	Indianapolis	Indiana	United States	46217
18	Northern Indiana Womens Heatlh Research, Inc.	South Bend	Indiana	United States	46601
19	Clinical Trials Management, LLC	Metairie	Louisiana	United States	70006
20	PPS Clinical Research, LLC	Chesterfield	Missouri	United States	63017
21	New Ballas OB-GYN, Inc.	St. Louis	Missouri	United States	63141
22	Women's Clinic of Lincoln, PC	Lincoln	Nebraska	United States	68510
23	Office of Dr. R. Garn Mabey, MD	Las Vegas	Nevada	United States	89128
24	Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08901
25	Lyndhurst Gynecologic Associates	Winston-Salem	North Carolina	United States	27103
26	Associates in OB-GYN, Inc.	Cincinnati	Ohio	United States	45246
27	Columbus Center for Women's Health Research	Columbus	Ohio	United States	43213
28	Oregon Health and Science University	Portland	Oregon	United States	97239-3011
29	Clinical Research of Philadelphia, LLC	Philadelphia	Pennsylvania	United States	19114
30	Holston Medical Group	Bristol	Tennessee	United States	37620
31	Adam Patterson OB-GYN	Memphis	Tennessee	United States	38120
32	The Woman's Hospital of Texas	Houston	Texas	United States	77054
33	North Spokane Women's Health Research	Spokane	Washington	United States	99207
34	University of Wisconsin - La Crosse	La Crosse	Wisconsin	United States	54601
35	Glover Medical Clinic	Langley	British Columbia	Canada	V3A 4H9
36	Maritimes Research Center	Bathurst	New Brunswick	Canada	E2A 4Z9
37	White Hills Medical Clinic	St. John's	Newfoundland and Labrador	Canada	A1A 3R5
38	MSHJ Research Associates	Halifax	Nova Scotia	Canada	B3K 5R3
39	Corunna Medical Research Centre	Corunna	Ontario	Canada	N0N 1G0
40	Office of Dr. Ivor Teitelbaum, MD	Downsview	Ontario	Canada	M3J 1N2
41	Office of Dr. Allen S. Greenspoon, MD	Hamilton	Ontario	Canada	L8L 5G8
42	Hamilton Medical Research Group	Hamilton	Ontario	Canada	L8M 1K7
43	Office of Dr. Sami Henein, MD	Newmarket	Ontario	Canada	L3Y 5G8
44	Ottawa Hospital-Riverside Campus	Ottawa	Ontario	Canada	K1H 7W9
45	London Road Diagnostic Centre	Sarnia	Ontario	Canada	N7T 4X3
46	Prime Health Research	Toronto	Ontario	Canada	M4S 1Y2
47	Manna Research	Toronto	Ontario	Canada	M9W 4L6
48	Devonshire Clinical Research, Inc.	Woodstock	Ontario	Canada	N4S 5P5
49	Island Clinical Trials	Charlottetown	Prince Edward Island	Canada	C1A 5Y9
50	Rhodin Recherche Clinique	Drummondville	Quebec	Canada	J2B 7T1
51	Omnispec Recherche Clinique Inc.	Mirabel	Quebec	Canada	J7J 1L2
52	Dynamik Clinical Research Group	Pointe-Claire	Quebec	Canada	H9R 3J1
53	Kells Medical Research Group, Inc.	Pointe-Claire	Quebec	Canada	H9R 4S3
54	Clinique de Gynecologie	Shawinigan	Quebec	Canada	G9N 2H6
55	Clinique Médicale des Campus	Ste-Foy	Quebec	Canada	G1V 4X7
56	Regina Medical Centre	Regina	Saskatchewan	Canada	S4P 3X1
57	Acadia Medical Centre	Saskatoon	Saskatchewan	Canada	S7H 5M3
58	Lenore Center Medical Clinic	Saskatoon	Saskatchewan	Canada	S7K 7H9
59	ALPHA Recherche Clinique	Quebec		Canada	G3K 2P8

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00754065
• Other Study ID Numbers: 13108
• First Posted: Sep 17, 2008
• Last Update Posted: Jul 19, 2013
• Last Verified: Jul 1, 2013

• Keywords provided by , ,: Oral contraceptive; Estradiol valerate and dienogest; EV/DNG; comparative tolerability
• Additional relevant MeSH terms: Moxifloxacin; Dienogest; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Norgestimate, ethinyl estradiol drug combination; Estradiol; Polyestradiol phosphate

Study Results

Participant Flow

Recruitment Details	The date of first subject first visit was 08 Sep 2008. The date of last subject last visit was 10 May 2011.
Pre-assignment Detail	A total of 776 participants were screened; 367 failed Screening, and 409 were randomized 1:1, of which 14 never received treatment, and 395 were treated (EV/DNG=191; EE/NGM=204). A total of 203 subjects (99 received EV/DNG and 104 EE/NGM) in the US and 192 (92 received EV/DNG and 100 EE/NGM) in Canada received at least one dose of the study drug.

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Period Title: Overall Study
STARTED	203	206
Participants Received Treatment	191	204
Cycle 6	141	153
COMPLETED	122	126
NOT COMPLETED	81	80

Baseline Characteristics

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo	Total
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Total of all reporting groups
Overall Participants	191	204	395
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	26.0 (6.6)	26.5 (7.2)	26.3 (6.9)
Sex: Female, Male (Count of Participants)
Female	191 100%	204 100%	395 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Number) [Number]
Caucasian	168 88%	180 88.2%	348 88.1%
Black	9 4.7%	9 4.4%	18 4.6%
Hispanic	6 3.1%	10 4.9%	16 4.1%
Asian	4 2.1%	2 1%	6 1.5%
Other	4 2.1%	3 1.5%	7 1.8%

Outcome Measures

1. Primary Outcome

Title	The Change in Average of the 3 Highest Visual Analog Scale (VAS) Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28 From Baseline to Cycle 6
Description	Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).
Time Frame	Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in Full Analysis Set (FAS) with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	158	173
Mean (Standard Deviation) [mm]	43.05 (23.58)	34.97 (25.90)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027), Ortho Tri-Cyclen Lo
	Comments	2-way ANOVA model with treatment and pain strata (headache and pelvic pain) as factors
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0024
	Comments	Comparison of EV/DNG vs. EE/NGM
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	F-statistic
	Estimated Value	9.3218
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	The Change From Baseline to Cycle 6 in the Number of Ibuprofen Tablets Used as Rescue Medication
Description	Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 6th treatment cycle until Day 28 of the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation (SD) derived.
Time Frame	From Baseline to Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	148	157
Days 1-21	-1.6 (9.9)	-3.0 (10.3)
Days 22-28	-5.8 (7.5)	-4.6 (8.0)

3. Secondary Outcome

Title	The Change From Baseline to Cycle 13 in the Number of Ibuprofen Tablets Used as Rescue Medication
Description	Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 13th treatment cycle until Day 28 before the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation ((SD) derived.
Time Frame	From Baseline to Cycle 13 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	125	126
Days 1-21	-2.3 (8.3)	-3.5 (12.0)
Days 22-28	-5.3 (7.6)	-5.2 (8.9)

4. Secondary Outcome

Title	Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28
Description	Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 22-28. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 22-28 before 1st menstrual bleeding (normalized to a 7-day period). Treatment period: cycle Days 22-28 before WB of 6th treatment cycle until (normalized to a 7-day period). Score difference min -7 (best), max 7 (worst).
Time Frame	Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	140	153
Headache	-1.950 (2.264)	-1.425 (2.223)
Pelvic pain	-1.921 (2.219)	-1.830 (2.093)
Bloating or swelling	-1.179 (2.051)	-1.131 (1.996)
Breast tenderness	-0.536 (1.702)	-0.497 (1.755)
Nausea or vomiting	-0.207 (1.089)	-0.229 (0.892)

5. Secondary Outcome

Title	Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28
Description	Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 22-28. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 22-28 before 1st menstrual bleeding (normalized to a 7-day period). Treatment period: cycle Days 22-28 before WB of 13th treatment cycle (normalized to a 7-day period). Score difference min -7 (best), max 7 (worst).
Time Frame	Day 22-28 from Baseline to Day 22-28 from Cycle 13 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	121	124
Headache	-1.909 (2.317)	-1.419 (2.053)
Pelvic pain	-2.091 (2.074)	-2.065 (2.233)
Bloating or swelling	-0.959 (1.855)	-1.379 (1.868)
Breast tenderness	-0.545 (1.727)	-0.677 (1.699)
Nausea or vomiting	-0.248 (1.113)	-0.266 (1.148)

6. Secondary Outcome

Title	Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21
Description	Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 1-21. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 1-21 before 1st menstrual bleeding (normalized to a 21-day period). Treatment period: cycle Days 1-21 before WB of 6th treatment cycle (normalized to a 21-day period). Score difference min -21 (best), max 21 (worst).
Time Frame	Day 1-21 from Baseline to Day 1-21 from Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	143	157
Headache	-1.077 (3.407)	-0.968 (2.688)
Pelvic pain	-0.399 (2.198)	-0.624 (2.147)
Bloating or swelling	-0.531 (2.325)	-0.210 (2.056)
Breast tenderness	-0.580 (1.798)	-0.248 (1.970)
Nausea or vomiting	-0.182 (1.555)	-0.172 (1.507)

7. Secondary Outcome

Title	Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21
Description	Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 1-21. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 1-21 before 1st menstrual bleeding (normalized to a 21-day period). Treatment period: cycle Days 1-21 before WB of 13th treatment cycle (normalized to a 21-day period). Score difference min -21 (best), max 21 (worst).
Time Frame	Day 1-21 from Baseline to Day 1-21 from Cycle 13 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	124	129
Headache	-1.121 (3.122)	-0.767 (2.983)
Pelvic pain	-0.274 (2.444)	-0.643 (2.113)
Bloating or swelling	-0.492 (1.944)	-0.279 (2.140)
Breast tenderness	-0.274 (1.467)	-0.217 (2.042)
Nausea or vomiting	-0.298 (1.391)	-0.240 (1.457)

8. Secondary Outcome

Title	Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM
Description	Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode (cycle Days 22-28). Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Score difference min -2 (best), max 2 (worst) for the estradiol valerate (EV)/dienogest (DNG) group and min -7 (best), max 7 (worst) for the ethinylestradiol (EE)/norgestimate (NGM) group.
Time Frame	From Baseline to Cycle 6 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	139	153
Headache	-0.424 (0.901)	-1.425 (2.223)
Pelvic pain	-0.273 (1.013)	-1.830 (2.093)
Bloating or swelling	-0.137 (0.773)	-1.131 (1.996)
Breast tenderness	-0.043 (0.588)	-0.497 (1.755)
Nausea or vomiting	-0.043 (0.378)	-0.229 (0.892)

9. Secondary Outcome

Title	Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM
Description	Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode (cycle Days 22-28). Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Score difference min -2 (best), max 2 (worst) for the EV/DNG group and min -7 (best), max 7 (worst) for the EE/NGM group.
Time Frame	From Baseline to Cycle 13 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	121	124
Headache	-0.537 (0.904)	-1.419 (2.053)
Pelvic pain	-0.322 (0.977)	-2.065 (2.233)
Bloating or swelling	-0.107 (0.716)	-1.379 (1.868)
Breast tenderness	-0.033 (0.515)	-0.677 (1.699)
Nausea or vomiting	-0.033 (0.407)	-0.266 (1.148)

10. Secondary Outcome

Title	Change From Baseline to Cycle 3 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28
Description	Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).
Time Frame	Days 22-28 from Baseline to Days 22-28 from Cycle 3 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	154	171
Mean (Standard Deviation) [mm]	36.92 (24.48)	32.28 (25.77)

11. Secondary Outcome

Title	Change From Baseline to Cycle 13 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28
Description	Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).
Time Frame	Days 22-28 from Baseline to Days 22-28 from Cycle 13 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	122	126
Mean (Standard Deviation) [mm]	45.89 (23.12)	39.19 (27.68)

12. Secondary Outcome

Title	Number of Days With Bleeding or Spotting in Reference Period 1
Description	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Time Frame	From Day 1 to Day 90

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	164	180
Mean (Standard Deviation) [Days]	19.0 (10.9)	23.7 (8.2)

13. Secondary Outcome

Title	Number of Days With Bleeding or Spotting in Reference Period 2
Description	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Time Frame	From Day 91 to Day 180

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	143	156
Mean (Standard Deviation) [Days]	1.3 (9.2)	18.8 (6.2)

14. Secondary Outcome

Title	Number of Days With Bleeding or Spotting in Reference Period 3
Description	Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
Time Frame	From Day 181 to Day 270

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	132	138
Mean (Standard Deviation) [Days]	14.1 (10.4)	19.1 (6.5)

15. Secondary Outcome

Title	Number of Days With Bleeding or Spotting in Reference Period 4
Description	Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
Time Frame	From Day 271 to Day 360

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	125	116
Mean (Standard Deviation) [Days]	12.8 (9.1)	19.4 (5.3)

16. Secondary Outcome

Title	Number of Bleeding / Spotting Episodes in Reference Period 1
Description	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. (Episode is a set of days with bleeding/spotting)
Time Frame	From Day 1 to Day 90

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	164	180
Mean (Standard Deviation) [Episodes]	3.6 (1.4)	3.7 (1.0)

17. Secondary Outcome

Title	Number of Bleeding / Spotting Episodes in Reference Period 2
Description	Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (Episode is a set of days with bleeding/spotting)
Time Frame	From Day 91 to Day 180

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	143	156
Mean (Standard Deviation) [Episodes]	3.3 (1.4)	3.4 (0.9)

18. Secondary Outcome

Title	Number of Bleeding / Spotting Episodes in Reference Period 3
Description	Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (Episode is a set of days with bleeding/spotting)
Time Frame	From Day 181 to Day 270

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	132	138
Mean (Standard Deviation) [Episodes]	3.0 (1.4)	3.3 (0.9)

19. Secondary Outcome

Title	Number of Bleeding / Spotting Episodes in Reference Period 4
Description	Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (Episode is a set of days with bleeding/spotting)
Time Frame	From Day 271 to Day 360

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	125	116
Mean (Standard Deviation) [Episodes]	3.0 (1.6)	3.7 (0.8)

20. Secondary Outcome

Title	Mean Length of Bleeding / Spotting Episodes in Reference Period 1
Description	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Time Frame	From Day 1 to Day 90

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	160	180
Mean (Standard Deviation) [Days]	4.82 (2.50)	6.20 (2.22)

21. Secondary Outcome

Title	Mean Length of Bleeding / Spotting Episodes in Reference Period 2
Description	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Time Frame	From Day 91 to Day 180

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	136	155
Mean (Standard Deviation) [Days]	4.46 (2.31)	5.71 (1.99)

22. Secondary Outcome

Title	Mean Length of Bleeding / Spotting Episodes in Reference Period 3
Description	Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
Time Frame	From Day 181 to Day 270

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	122	138
Mean (Standard Deviation) [Days]	4.70 (2.68)	5.85 (1.53)

23. Secondary Outcome

Title	Mean Length of Bleeding / Spotting Episodes in Reference Period 4
Description	Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
Time Frame	From Day 271 to Day 360

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	113	116
Mean (Standard Deviation) [Days]	4.25 (1.57)	5.65 (1.19)

24. Secondary Outcome

Title	Maximum Length of Bleeding / Spotting Episodes in Reference Period 1
Description	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Time Frame	From Day 1 to Day 90

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	160	180
Mean (Standard Deviation) [Days]	7.8 (5.5)	9.0 (4.3)

25. Secondary Outcome

Title	Maximum Length of Bleeding / Spotting Episodes in Reference Period 2
Description	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Time Frame	From Day 91 to Day 180

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	136	155
Mean (Standard Deviation) [Days]	6.2 (3.5)	7.5 (3.7)

26. Secondary Outcome

Title	Maximum Length of Bleeding / Spotting Episodes in Reference Period 3
Description	Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
Time Frame	From Day 181 to Day 270

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	122	138
Mean (Standard Deviation) [Days]	6.2 (3.5)	7.4 (2.8)

27. Secondary Outcome

Title	Maximum Length of Bleeding / Spotting Episodes in Reference Period 4
Description	Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
Time Frame	From Day 271 to Day 360

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	113	116
Mean (Standard Deviation) [Days]	5.7 (3.0)	7.1 (2.3)

28. Secondary Outcome

Title	Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1
Description	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Time Frame	From Day 1 to Day 90

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	160	180
Mean (Standard Deviation) [Days]	5.1 (5.3)	5.1 (4.2)

29. Secondary Outcome

Title	Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2
Description	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Time Frame	From Day 91 to Day 180

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	136	155
Mean (Standard Deviation) [Days]	3.3 (3.2)	3.5 (3.9)

30. Secondary Outcome

Title	Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 3
Description	Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
Time Frame	From Day 181 to Day 270

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	122	138
Mean (Standard Deviation) [Days]	3.0 (3.0)	3.1 (3.2)

31. Secondary Outcome

Title	Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 4
Description	Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
Time Frame	From Day 271 to Day 360

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	113	116
Mean (Standard Deviation) [Days]	2.7 (3.3)	2.8 (2.9)

32. Secondary Outcome

Title	Number of Days With Spotting-only in Reference Period 1
Description	Reference Period 1 is defined as Day 1 to Day 90 during study treatment.
Time Frame	From Day 1 to Day 90

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	164	180
Mean (Standard Deviation) [Days]	9.3 (7.5)	8.6 (5.6)

33. Secondary Outcome

Title	Number of Days With Spotting-only in Reference Period 2
Description	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Time Frame	From Day 91 to Day 180

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	143	156
Mean (Standard Deviation) [Days]	6.8 (6.2)	6.4 (4.8)

34. Secondary Outcome

Title	Number of Days With Spotting-only in Reference Period 3
Description	Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
Time Frame	From Day 181 to Day 270

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	132	138
Mean (Standard Deviation) [Days]	6.6 (7.1)	6.3 (4.8)

35. Secondary Outcome

Title	Number of Days With Spotting-only in Reference Period 4
Description	Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
Time Frame	From Day 271 to Day 360

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	125	116
Mean (Standard Deviation) [Days]	5.6 (6.1)	5.6 (3.2)

36. Secondary Outcome

Title	Number of Spotting-only Episodes in Reference Period 1
Description	Reference Period 1 is defined as Day 1 to Day 90 during study treatment.
Time Frame	From Day 1 to Day 90

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	164	180
Mean (Standard Deviation) [Episodes]	1.2 (1.3)	0.5 (0.8)

37. Secondary Outcome

Title	Number of Spotting-only Episodes in Reference Period 2
Description	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Time Frame	From Day 91 to Day 180

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	143	156
Mean (Standard Deviation) [Episodes]	1.0 (1.2)	0.5 (0.9)

38. Secondary Outcome

Title	Number of Spotting-only Episodes in Reference Period 3
Description	Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
Time Frame	From Day 181 to Day 270

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	132	138
Mean (Standard Deviation) [Episodes]	0.7 (1.1)	0.3 (0.6)

39. Secondary Outcome

Title	Number of Spotting-only Episodes in Reference Period 4
Description	Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
Time Frame	From Day 271 to Day 360

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	125	116
Mean (Standard Deviation) [Episodes]	0.6 (1.1)	0.2 (0.5)

40. Secondary Outcome

Title	Mean Length of Spotting-only Episodes in Reference Period 1
Description	Reference Period 1 is defined as Day 1 to Day 90 during study treatment.
Time Frame	From Day 1 to Day 90

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	97	59
Mean (Standard Deviation) [Days]	2.64 (1.67)	2.53 (1.79)

41. Secondary Outcome

Title	Mean Length of Spotting-only Episodes in Reference Period 2
Description	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Time Frame	From Day 91 to Day 180

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	73	48
Mean (Standard Deviation) [Days]	2.74 (1.57)	2.77 (2.24)

42. Secondary Outcome

Title	Mean Length of Spotting-only Episodes in Reference Period 3
Description	Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
Time Frame	From Day 181 to Day 270

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	51	26
Mean (Standard Deviation) [Days]	2.75 (1.49)	2.44 (1.54)

43. Secondary Outcome

Title	Mean Length of Spotting-only Episodes in Reference Period 4
Description	Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
Time Frame	From Day 271 to Day 360

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	49	21
Mean (Standard Deviation) [Days]	2.77 (1.77)	2.10 (1.27)

44. Secondary Outcome

Title	Maximum Length of Spotting-only Episodes in Reference Period 1
Description	Reference Period 1 is defined as Day 1 to Day 90 during study treatment.
Time Frame	From Day 1 to Day 90

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	97	59
Mean (Standard Deviation) [Days]	3.3 (2.4)	2.8 (1.9)

45. Secondary Outcome

Title	Maximum Length of Spotting-only Episodes in Reference Period 2
Description	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Time Frame	From Day 91 to Day 180

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	73	48
Mean (Standard Deviation) [Days]	3.2 (1.9)	3.1 (2.4)

46. Secondary Outcome

Title	Maximum Length of Spotting-only Episodes in Reference Period 3
Description	Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
Time Frame	From Day 181 to Day 270

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	51	26
Mean (Standard Deviation) [Days]	3.5 (2.2)	2.8 (1.9)

47. Secondary Outcome

Title	Maximum Length of Spotting-only Episodes in Reference Period 4
Description	Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
Time Frame	From Day 271 to Day 360

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	49	21
Mean (Standard Deviation) [Days]	3.2 (2.3)	2.2 (1.3)

48. Secondary Outcome

Title	Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1
Description	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Time Frame	From Day 1 to Day 90

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	97	59
Mean (Standard Deviation) [Days]	1.2 (2.1)	0.5 (1.1)

49. Secondary Outcome

Title	Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2
Description	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Time Frame	From Day 91 to Day 180

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	73	48
Mean (Standard Deviation) [Days]	1.0 (1.5)	0.7 (1.3)

50. Secondary Outcome

Title	Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 3
Description	Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
Time Frame	From Day 181 to Day 270

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	51	26
Mean (Standard Deviation) [Days]	1.4 (2.1)	0.6 (1.6)

51. Secondary Outcome

Title	Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 4
Description	Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
Time Frame	From Day 271 to Day 360

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	49	21
Mean (Standard Deviation) [Days]	0.9 (1.9)	0.2 (0.5)

52. Secondary Outcome

Title	Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1
Description	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.
Time Frame	At Cycle 1 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	180	188
without withdrawal bleeding	25.0 13.1%	12.8 6.3%
with withdrawal bleeding	75.0 39.3%	87.2 42.7%

53. Secondary Outcome

Title	Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3
Description	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.
Time Frame	At Cycle 3 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	167	182
without withdrawal bleeding	21.0 11%	7.7 3.8%
with withdrawal bleeding	79.0 41.4%	92.3 45.2%

54. Secondary Outcome

Title	Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6
Description	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.
Time Frame	At Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	147	157
without withdrawal bleeding	17.7 9.3%	8.3 4.1%
with withdrawal bleeding	82.3 43.1%	91.7 45%

55. Secondary Outcome

Title	Percentage of Participants With / Without Withdrawal Bleeding at Cycle 13
Description	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.
Time Frame	At Cycle 13 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	110	110
without withdrawal bleeding	58.2 30.5%	19.1 9.4%
with withdrawal bleeding	41.8 21.9%	80.9 39.7%

56. Secondary Outcome

Title	Length of Withdrawal Bleeding Episodes at Cycle 1
Description	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.
Time Frame	At Cycle 1 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	135	164
Mean (Standard Deviation) [Days]	4.2 (2.3)	6.0 (2.6)

57. Secondary Outcome

Title	Length of Withdrawal Bleeding Episodes at Cycle 3
Description	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.
Time Frame	At Cycle 3 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	132	168
Mean (Standard Deviation) [Days]	4.3 (2.1)	5.8 (2.0)

58. Secondary Outcome

Title	Length of Withdrawal Bleeding Episodes at Cycle 6
Description	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.
Time Frame	At Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	121	144
Mean (Standard Deviation) [Days]	4.6 (3.2)	5.7 (1.9)

59. Secondary Outcome

Title	Length of Withdrawal Bleeding Episodes at Cycle 13
Description	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.
Time Frame	At Cycle 13 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	46	89
Mean (Standard Deviation) [Days]	4.8 (1.8)	5.5 (1.5)

60. Secondary Outcome

Title	Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1
Description	Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
Time Frame	At Cycle 1 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	135	164
Mean (Standard Deviation) [Scores on a scale]	3.2 (0.9)	4.0 (0.8)

61. Secondary Outcome

Title	Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3
Description	Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
Time Frame	At Cycle 3 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	132	168
Mean (Standard Deviation) [Scores on a scale]	3.2 (0.9)	4.2 (0.7)

62. Secondary Outcome

Title	Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6
Description	Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
Time Frame	At Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	121	144
Mean (Standard Deviation) [Scores on a scale]	3.4 (0.8)	4.0 (0.8)

63. Secondary Outcome

Title	Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 13
Description	Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
Time Frame	At Cycle 13 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	46	89
Mean (Standard Deviation) [Scores on a scale]	3.5 (0.7)	4.1 (0.7)

64. Secondary Outcome

Title	Onset of Withdrawal Bleeding Episodes at Cycle 1
Description	Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).
Time Frame	At Cycle 1 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	135	164
Mean (Standard Deviation) [Days]	4.7 (7.0)	4.0 (6.7)

65. Secondary Outcome

Title	Onset of Withdrawal Bleeding Episodes at Cycle 3
Description	Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).
Time Frame	At Cycle 3 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	132	168
Mean (Standard Deviation) [Days]	4.3 (7.0)	3.3 (4.7)

66. Secondary Outcome

Title	Onset of Withdrawal Bleeding Episodes at Cycle 6
Description	Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).
Time Frame	At Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	121	144
Mean (Standard Deviation) [Days]	5.3 (7.7)	3.1 (5.1)

67. Secondary Outcome

Title	Onset of Withdrawal Bleeding Episodes at Cycle 13
Description	Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).
Time Frame	At Cycle 13 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	46	89
Mean (Standard Deviation) [Days]	1.1 (2.2)	2.1 (1.6)

68. Secondary Outcome

Title	Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame	At Cycle 1 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	180	188
with absence of intracyclic bleeding	78.3 41%	91.5 44.9%
without absence of intracyclic bleeding	21.7 11.4%	8.5 4.2%

69. Secondary Outcome

Title	Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame	At Cycle 3 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	167	182
with absence of intracyclic bleeding	79.6 41.7%	85.7 42%
without absence of intracyclic bleeding	20.4 10.7%	14.3 7%

70. Secondary Outcome

Title	Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame	At Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	147	157
with absence of intracyclic bleeding	81.6 42.7%	80.3 39.4%
without absence of intracyclic bleeding	18.4 9.6%	19.7 9.7%

71. Secondary Outcome

Title	Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 13
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame	At Cycle 13 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	110	110
with absence of intracyclic bleeding	82.7 43.3%	93.6 45.9%
without absence of intracyclic bleeding	17.3 9.1%	6.4 3.1%

72. Secondary Outcome

Title	Number of Intracyclic Bleeding Episodes at Cycle 1
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)
Time Frame	At Cycle 1 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	180	188
Mean (Standard Deviation) [Episodes]	0.3 (0.5)	0.1 (0.3)

73. Secondary Outcome

Title	Number of Intracyclic Bleeding Episodes at Cycle 3
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)
Time Frame	At Cycle 3 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	167	182
Mean (Standard Deviation) [Episodes]	0.2 (0.5)	0.2 (0.5)

74. Secondary Outcome

Title	Number of Intracyclic Bleeding Episodes at Cycle 6
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)
Time Frame	At Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	147	157
Mean (Standard Deviation) [Episodes]	0.2 (0.4)	0.2 (0.5)

75. Secondary Outcome

Title	Number of Intracyclic Bleeding Episodes at Cycle 13
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)
Time Frame	At Cycle 13 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	110	110
Mean (Standard Deviation) [Episodes]	0.2 (0.4)	0.1 (0.3)

76. Secondary Outcome

Title	Maximum Length of Intracyclic Bleeding Episodes at Cycle 1
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame	At Cycle 1 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	39	16
Mean (Standard Deviation) [Days]	6.7 (8.5)	6.2 (6.2)

77. Secondary Outcome

Title	Maximum Length of Intracyclic Bleeding Episodes at Cycle 3
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame	At Cycle 3 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	34	26
Mean (Standard Deviation) [Days]	6.6 (6.0)	4.2 (3.9)

78. Secondary Outcome

Title	Maximum Length of Intracyclic Bleeding Episodes at Cycle 6
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame	At Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	27	31
Mean (Standard Deviation) [Days]	5.0 (4.9)	5.2 (5.0)

79. Secondary Outcome

Title	Maximum Length of Intracyclic Bleeding Episodes at Cycle 13
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame	At Cycle 13 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	19	7
Mean (Standard Deviation) [Days]	3.0 (2.2)	6.0 (5.9)

80. Secondary Outcome

Title	Number of Intracyclic Bleeding Days at Cycle 1
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame	At Cycle 1 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	180	188
Mean (Standard Deviation) [Days]	1.5 (4.8)	0.5 (2.5)

81. Secondary Outcome

Title	Number of Intracyclic Bleeding Days at Cycle 3
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame	At Cycle 3 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	167	182
Mean (Standard Deviation) [Days]	1.4 (3.8)	0.7 (2.2)

82. Secondary Outcome

Title	Number of Intracyclic Bleeding Days at Cycle 6
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame	At Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	147	157
Mean (Standard Deviation) [Days]	0.9 (2.9)	1.1 (3.1)

83. Secondary Outcome

Title	Number of Intracyclic Bleeding Days at Cycle 13
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame	At Cycle 13 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	110	110
Mean (Standard Deviation) [Days]	0.5 (1.5)	0.4 (2.1)

84. Secondary Outcome

Title	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
Time Frame	At Cycle 1 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	39	16
Spotting	46.2 24.2%	50.0 24.5%
Light	23.1 12.1%	18.8 9.2%
Normal	15.4 8.1%	18.8 9.2%
Heavy	15.4 8.1%	12.5 6.1%

85. Secondary Outcome

Title	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
Time Frame	At Cycle 3 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	34	26
Spotting	47.1 24.7%	57.7 28.3%
Light	23.5 12.3%	15.4 7.5%
Normal	20.6 10.8%	23.1 11.3%
Heavy	8.8 4.6%	3.8 1.9%

86. Secondary Outcome

Title	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
Time Frame	At Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	27	31
Spotting	44.4 23.2%	61.3 30%
Light	25.9 13.6%	3.2 1.6%
Normal	18.5 9.7%	19.4 9.5%
Heavy	11.1 5.8%	16.1 7.9%

87. Secondary Outcome

Title	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 13
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
Time Frame	At Cycle 13 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	19	7
Spotting	31.6 16.5%	57.1 28%
Light	52.6 27.5%	0.0 0%
Normal	10.5 5.5%	28.6 14%
Heavy	5.3 2.8%	14.3 7%

88. Secondary Outcome

Title	Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 6
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame	Cycles 2 to 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	184	195
Yes	53.8 28.2%	40.5 19.9%
No	46.2 24.2%	59.5 29.2%

89. Secondary Outcome

Title	Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 13
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame	Cycles 2 to 13 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	184	195
Yes	62.0 32.5%	49.7 24.4%
No	38.0 19.9%	50.3 24.7%

90. Secondary Outcome

Title	Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI)
Description	Change from Baseline to Cycle 6 in PGWBI Questionnaire's assessment of participant's overall sense of well-being or distress. The PGWBI includes 22 items that, apart from combining into a global overall score, are divided into 6 dimensions: anxiety, depressed mood, positive well-being, self-control, health, and vitality. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score as well as all the sub-domains score ranges from -100 (worst) to 100 (best).
Time Frame	Baseline up to Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	147	155
Global score	0.41 (6.16)	1.10 (6.96)
Anxiety	0.3 (13.9)	2.8 (16.8)
Depressed mood	0.18 (11.10)	-1.04 (13.73)
Positive well-being	49.66 (5.99)	50.29 (6.60)
Self-control	0.69 (9.04)	0.12 (9.17)
General health	81.81 (13.94)	81.12 (13.38)
Vitality	-0.17 (8.98)	0.19 (9.55)

91. Secondary Outcome

Title	Mean Change From Baseline to Cycle 13 in Psychological General Well-Being Index (PGWBI)
Description	Change from Baseline to Cycle 13 in PGWBI Questionnaire's assessment of participant's overall sense of well-being or distress. The PGWBI includes 22 items that, apart from combining into a global overall score, are divided into 6 dimensions: anxiety, depressed mood, positive well-being, self-control, health, and vitality. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score as well as all the sub-domains score ranges from -100 (worst) to 100 (best).
Time Frame	Baseline up to Cycle 13 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	124	128
Global score	-0.14 (7.41)	-0.18 (9.08)
Anxiety	-1.2 (16.6)	-0.8 (20.4)
Depressed mood	-0.65 (13.18)	-0.98 (15.96)
Positive well-being	0.60 (8.13)	0.38 (8.43)
Self-control	-0.49 (9.47)	-0.16 (9.19)
General health	0.86 (14.46)	1.35 (16.15)
Vitality	0.28 (10.99)	-0.51 (11.22)

92. Secondary Outcome

Title	Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Physical Health
Description	Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (physical health - 13 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Time Frame	Baseline up to Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	147	155
Mean (Standard Deviation) [Scores on a scale]	1.13 (14.09)	3.44 (14.32)

93. Secondary Outcome

Title	Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Physical Health
Description	Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (physical health - 13 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Time Frame	Baseline up to Cycle 13 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	124	128
Mean (Standard Deviation) [Scores on a scale]	1.93 (14.37)	2.13 (15.21)

94. Secondary Outcome

Title	Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Participant Feeling
Description	Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (participant feeling - 14 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Time Frame	Baseline up to Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	147	155
Mean (Standard Deviation) [Scores on a scale]	0.12 (9.76)	2.19 (10.96)

95. Secondary Outcome

Title	Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Participant Feeling
Description	Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (participant feeling - 14 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Time Frame	Baseline up to Cycle 13 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	124	128
Mean (Standard Deviation) [Scores on a scale]	-0.44 (12.36)	0.39 (14.35)

96. Secondary Outcome

Title	Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Work
Description	Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (work - yes or no; if yes, then 4 choices, and 13 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Time Frame	Baseline up to Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	118	135
Mean (Standard Deviation) [Scores on a scale]	0.54 (9.03)	0.08 (10.87)

97. Secondary Outcome

Title	Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Work
Description	Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (work - yes or no; if yes, then 4 choices, and 13 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Time Frame	Baseline up to Cycle 13 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	105	107
Mean (Standard Deviation) [Scores on a scale]	-1.38 (12.11)	-1.71 (17.07)

98. Secondary Outcome

Title	Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Household Duties
Description	Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (household duties - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Time Frame	Baseline up to Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	140	153
Mean (Standard Deviation) [Scores on a scale]	1.50 (12.16)	3.08 (14.83)

99. Secondary Outcome

Title	Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Household Duties
Description	Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (household duties - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Time Frame	Baseline up to Cycle 13 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	117	125
Mean (Standard Deviation) [Scores on a scale]	-0.66 (14.31)	2.83 (18.23)

100. Secondary Outcome

Title	Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - School/Course Work
Description	Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (school / course work - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Time Frame	Baseline up to Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	28	35
Mean (Standard Deviation) [Scores on a scale]	-0.18 (12.84)	5.13 (17.43)

101. Secondary Outcome

Title	Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - School/Course Work
Description	Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (school / course work - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Time Frame	Baseline up to Cycle 13 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	19	30
Mean (Standard Deviation) [Scores on a scale]	-1.97 (18.09)	4.39 (16.40)

102. Secondary Outcome

Title	Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Leisure Time Activities
Description	Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (leisure time activities - 6 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Time Frame	Baseline up to Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	147	155
Mean (Standard Deviation) [Scores on a scale]	1.22 (12.0)	2.77 (14.36)

103. Secondary Outcome

Title	Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Leisure Time Activities
Description	Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (leisure time activities - 6 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Time Frame	Baseline up to Cycle 13 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	124	128
Mean (Standard Deviation) [Scores on a scale]	2.72 (14.45)	2.37 (15.19)

104. Secondary Outcome

Title	Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Social Relationship
Description	Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (social relationship - 11 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Time Frame	Baseline up to Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	147	155
Mean (Standard Deviation) [Scores on a scale]	-0.30 (11.15)	0.41 (13.52)

105. Secondary Outcome

Title	Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Social Relationship
Description	Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (social relationship - 11 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Time Frame	Baseline up to Cycle 13 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	124	128
Mean (Standard Deviation) [Scores on a scale]	1.01 (12.58)	1.75 (13.94)

106. Secondary Outcome

Title	Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - General Activities
Description	Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (general activities - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Time Frame	Baseline up to Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	147	155
Mean (Standard Deviation) [Scores on a scale]	0.56 (9.83)	1.27 (10.55)

107. Secondary Outcome

Title	Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - General Activities
Description	Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (general activities - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Time Frame	Baseline up to Cycle 13 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	124	128
Mean (Standard Deviation) [Scores on a scale]	0.73 (10.28)	1.34 (13.03)

108. Secondary Outcome

Title	Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Item Satisfaction
Description	Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (item satisfaction). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Time Frame	Baseline up to Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	110	129
Mean (Standard Deviation) [Scores on a scale]	-0.1 (0.7)	0.1 (0.9)

109. Secondary Outcome

Title	Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Item Satisfaction
Description	Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (item satisfaction). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Time Frame	Baseline up to Cycle 13 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	93	107
Mean (Standard Deviation) [Scores on a scale]	0.0 (0.6)	0.1 (0.9)

110. Secondary Outcome

Title	Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Overall Life Satisfaction and Contentment
Description	Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (overall life satisfaction and contentment). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Time Frame	Baseline up to Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	147	155
Mean (Standard Deviation) [Scores on a scale]	-0.1 (0.7)	0.0 (0.8)

111. Secondary Outcome

Title	Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Overall Life Satisfaction and Contentment
Description	Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (overall life satisfaction and contentment). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Time Frame	Baseline up to Cycle 13 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	124	128
Mean (Standard Deviation) [Scores on a scale]	-0.1 (0.8)	0.0 (0.8)

112. Secondary Outcome

Title	Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6
Description	CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.
Time Frame	At Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	147	155
Very much improved	21.1 11%	20.0 9.8%
Much improved	41.5 21.7%	25.2 12.4%
Minimally improved	27.2 14.2%	33.5 16.4%

113. Secondary Outcome

Title	Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 13
Description	CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.
Time Frame	At Cycle 13 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	124	128
Very much improved	37.9 19.8%	20.3 10%
Much improved	32.3 16.9%	26.6 13%
Minimally improved	15.3 8%	27.3 13.4%

114. Secondary Outcome

Title	Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6
Description	In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.
Time Frame	At Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	147	155
Very much improved	25.2 13.2%	11.6 5.7%
Much improved	32.7 17.1%	30.3 14.9%
Minimally improved	29.3 15.3%	32.2 15.8%

115. Secondary Outcome

Title	Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 13
Description	In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.
Time Frame	At Cycle 13 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	124	128
Very much improved	33.9 17.7%	17.2 8.4%
Much improved	35.5 18.6%	25.0 12.3%
Minimally improved	16.9 8.8%	28.1 13.8%

116. Other Pre-specified Outcome

Title	Percentage of Participants With no Increase in Rescue Medication and VAS Decrease During Cycle Days 22 to 28 From Baseline to Cycle 6
Description	Rescue medication was standardized intake of 200 mg Ibuprofen tablets. Baseline: 7 days (Day 22) before first menstrual bleeding to Day 28. Treatment: 7 days (Day 22) before withdrawal bleeding of 6th cycle to Day 28 before the same cycle. The visual analog scale (VAS) is a subject-assessed measure of pelvic pain or headache consisting of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).
Time Frame	Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	191	204
15 mm VAS decrease	68.1 35.7%	54.4 26.7%
30 mm VAS decrease	58.1 30.4%	42.6 20.9%
45 mm VAS decrease	38.2 20%	26.0 12.7%
25% VAS decrease	67.0 35.1%	54.4 26.7%
50% VAS decrease	56.0 29.3%	42.2 20.7%
75% VAS decrease	38.2 20%	25.5 12.5%
Half-SD decrease	70.2 36.8%	59.8 29.3%

117. Other Pre-specified Outcome

Title	The Change of Pelvic Pain or Headache as Determined by the Highest Visual Analog Scale (VAS) Values During Cycle Days 22 to 28 From Baseline to Cycle 6
Description	Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).
Time Frame	Days 22-28 from Baseline to Days 22-28 from Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)	Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Measure Participants	141	153
Mean (Standard Deviation) [mm]	43.60 (29.16)	34.55 (30.64)

Adverse Events

Arm/Group Title	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)		Ortho Tri-Cyclen Lo
Arm/Group Description	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles(treatment encapsulated)		Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
All Cause Mortality
	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)		Ortho Tri-Cyclen Lo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)		Ortho Tri-Cyclen Lo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/191 (1%)		5/204 (2.5%)
Endocrine disorders
Diabetes insipidus	0/191 (0%)		1/204 (0.5%)
Hepatobiliary disorders
Cholecystitis	0/191 (0%)		1/204 (0.5%)
Infections and infestations
Pharyngitis bacterial	1/191 (0.5%)		0/204 (0%)
Nervous system disorders
Loss of consciousness	0/191 (0%)		1/204 (0.5%)
Migraine with aura	0/191 (0%)		2/204 (1%)
Speech disorder	0/191 (0%)		1/204 (0.5%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	1/191 (0.5%)		0/204 (0%)
Psychiatric disorders
Disorientation	0/191 (0%)		1/204 (0.5%)
Other (Not Including Serious) Adverse Events
	Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)		Ortho Tri-Cyclen Lo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	154/191 (80.6%)		159/204 (77.9%)
Gastrointestinal disorders
Abdominal distension	28/191 (14.7%)		35/204 (17.2%)
Abdominal pain	6/191 (3.1%)		4/204 (2%)
Constipation	3/191 (1.6%)		5/204 (2.5%)
Diarrhoea	5/191 (2.6%)		2/204 (1%)
Nausea	27/191 (14.1%)		30/204 (14.7%)
Vomiting	19/191 (9.9%)		9/204 (4.4%)
General disorders
Swelling	3/191 (1.6%)		5/204 (2.5%)
Immune system disorders
Seasonal allergy	2/191 (1%)		6/204 (2.9%)
Infections and infestations
Fungal infection	6/191 (3.1%)		5/204 (2.5%)
Influenza	8/191 (4.2%)		4/204 (2%)
Nasopharyngitis	22/191 (11.5%)		20/204 (9.8%)
Sinusitis	13/191 (6.8%)		10/204 (4.9%)
Upper respiratory tract infection	12/191 (6.3%)		11/204 (5.4%)
Urinary tract infection	23/191 (12%)		10/204 (4.9%)
Vaginitis bacterial	7/191 (3.7%)		8/204 (3.9%)
Vulvovaginal mycotic infection	4/191 (2.1%)		2/204 (1%)
Injury, poisoning and procedural complications
Procedural pain	5/191 (2.6%)		2/204 (1%)
Investigations
Weight increased	4/191 (2.1%)		4/204 (2%)
White blood cells urine positive	5/191 (2.6%)		5/204 (2.5%)
Human papilloma virus test positive	10/191 (5.2%)		7/204 (3.4%)
Musculoskeletal and connective tissue disorders
Arthralgia	5/191 (2.6%)		2/204 (1%)
Back pain	8/191 (4.2%)		8/204 (3.9%)
Neck pain	1/191 (0.5%)		5/204 (2.5%)
Nervous system disorders
Dizziness	3/191 (1.6%)		5/204 (2.5%)
Headache	56/191 (29.3%)		50/204 (24.5%)
Migraine	4/191 (2.1%)		3/204 (1.5%)
Sinus headache	4/191 (2.1%)		0/204 (0%)
Psychiatric disorders
Anxiety	1/191 (0.5%)		5/204 (2.5%)
Mood swings	3/191 (1.6%)		7/204 (3.4%)
Reproductive system and breast disorders
Amenorrhoea	20/191 (10.5%)		1/204 (0.5%)
Breast pain	4/191 (2.1%)		3/204 (1.5%)
Breast tenderness	23/191 (12%)		27/204 (13.2%)
Cervical dysplasia	22/191 (11.5%)		20/204 (9.8%)
Dysmenorrhoea	18/191 (9.4%)		17/204 (8.3%)
Menorrhagia	4/191 (2.1%)		5/204 (2.5%)
Menstruation delayed	5/191 (2.6%)		3/204 (1.5%)
Metrorrhagia	31/191 (16.2%)		25/204 (12.3%)
Pelvic pain	46/191 (24.1%)		47/204 (23%)
Respiratory, thoracic and mediastinal disorders
Nasal congestion	2/191 (1%)		6/204 (2.9%)
Skin and subcutaneous tissue disorders
Acne	5/191 (2.6%)		5/204 (2.5%)
Dermatitis	4/191 (2.1%)		0/204 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Institution and/or Principal Investigator shall furnish the Sponsor with a copy of any proposed publication material at least sixty (60) days in advance of the date of submission for publication or presentation so that the proposed publication may be edited appropriately to remove any confidential information before publication or the Sponsor shall have sufficient additional time (not to exceed sixty (60) days) to file a patent application for such Confidential Information.