Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea
Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT00461305
Collaborator
(none)
420
26
2
30
16.2
0.5
Study Details
Study Description
Brief Summary
The purpose of this study is to investigate efficacy of ethinylestradiol for intracyclic bleeding profile in patients with dysmenorrhea and to investigate the long term safety
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Detailed Description
The "drospirenone 3 mg/ethinylestradiol 20 μg (13 cycles)" group is to be treated by oral administration for 52 weeks, 13 cycles. The "drospirenone 3 mg/ethinylestradiol 30 μg (6 cycles)" group is to be treated by oral administration for 24 weeks, 6 cycles.
The trial is sponsored by Bayer Yakuhin, Ltd.
Study Design
Study Type:
Interventional
Actual Enrollment
:
420 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Single-blind, Randomized Study, to Investigate Efficacy of Ethinylestradiol for Intracyclic Bleeding Profile During 24 Weeks (6 Cycles) by Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg and Drospirenone 3 mg/ Ethinylestradiol 30 µg in Patients With Dysmenorrheal and to Investigate the Long Term Safety Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg Administered for 52 Weeks (13 Cycles)
Study Start Date
:
Feb 1, 2007
Actual Primary Completion Date
:
Jan 1, 2009
Actual Study Completion Date
:
Aug 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DRSP 3 mg/EE 20 µg (13 cycles) 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) |
Drug: DRSP 3 mg/EE 20 µg (13 cycles)
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
|
| Experimental: DRSP 3 mg/EE 30 µg (6 cycles) 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) |
Drug: DRSP 3 mg/EE 30 µg (6 cycles)
1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Intracyclic Bleeding at Cycle 6 [Up to Cycle 6 (168 days) with 28 days per cycle]
Intracyclic bleedings were defined as bleedings while a participant takes active tablets.
Secondary Outcome Measures
- Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 [From baseline up to Cycle 6 (168 days) with 28 days per cycle]
Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change.
- Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13 [From baseline up to Cycle 13 (364 days) with 28 days per cycle]
Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change.
- Distribution of Total Dysmenorrhea Score at Cycle 6 [Up to Cycle 6 (168 days) with 28 days per cycle]
Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.
- Distribution of Total Dysmenorrhea Score at Cycle 13 [Up to Cycle 13 (364 days) with 28 days per cycle]
Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.
- Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6 [Up to Cycle 6 (168 days) with 28 days per cycle]
Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
- Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13 [Up to Cycle 13 (364 days) with 28 days per cycle]
Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
- Distribution of Severity of Lumbago During Menstruation at Cycle 6 [Up to Cycle 6 (168 days) with 28 days per cycle]
Severity of lumbago during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
- Distribution of Severity of Lumbago During Menstruation at Cycle 13 [Up to Cycle 13 (364 days) with 28 days per cycle]
Severity of lumbago during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
- Distribution of Severity of Headache During Menstruation at Cycle 6 [Up to Cycle 6 (168 days) with 28 days per cycle]
Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
- Distribution of Severity of Headache During Menstruation at Cycle 13 [Up to Cycle 13 (364 days) with 28 days per cycle]
Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
- Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6 [Up to Cycle 6 (168 days) with 28 days per cycle]
Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
- Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13 [Up to Cycle 13 (364 days) with 28 days per cycle]
Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
- Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6 [Up to Cycle 6 (168 days) with 28 days per cycle]
Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.
- Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13 [Up to Cycle 13 (364 days) with 28 days per cycle]
Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.
- Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 6 [From baseline up to Cycle 6 (168 days) with 28 days per cycle]
VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).
- Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 13 [From baseline up to Cycle 13 (364 days) with 28 days per cycle]
VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).
- Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 6 [From baseline up to Cycle 6 (168 days) with 28 days per cycle]
VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).
- Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 13 [From baseline up to Cycle 13 (364 days) with 28 days per cycle]
VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).
- Number of Any Bleeding Episodes From Cycle 1 to Cycle 6 [Up to Cycle 6 (168 days) with 28 days per cycle]
Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days).
- Number of Any Bleeding Episodes From Cycle 1 to Cycle 13 [Up to Cycle 13 (364 days) with 28 days per cycle]
Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days), reference period 3 is from Cycle 7 to Cycle 9 (the 3rd 90 days), reference period 4 is from Cycle 10 to Cycle 12 (the 4th 90 days).
- Number of Any Bleeding Days From Cycle 1 to Cycle 6 [Up to Cycle 6 (168 days) with 28 days per cycle]
Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days).
- Number of Any Bleeding Days From Cycle 1 to Cycle 13 [Up to Cycle 13 (364 days) with 28 days per cycle]
Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 4 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days), reference period 3 is from Cycle 7 to Cycle 9 (the 3rd 90 days), reference period 4 is from Cycle 10 to Cycle 12 (the 4th 90 days).
- Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6 [Up to Cycle 6 (168 days) with 28 days per cycle]
Intracyclic bleedings were defined as bleedings while a participant takes active tablets.
- Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13 [Up to Cycle 13 (364 days) with 28 days per cycle]
Intracyclic bleedings were defined as bleedings while a participant takes active tablets.
- Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6 [Up to Cycle 6 (168 days) with 28 days per cycle]
Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.
- Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13 [Up to Cycle 13 (364 days) with 28 days per cycle]
Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.
- Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6 [Up to Cycle 6 (168 days) with 28 days per cycle]
Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).
- Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13 [Up to Cycle 13 (364 days) with 28 days per cycle]
Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).
- Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6 [Up to Cycle 6 (168 days) with 28 days per cycle]
Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).
- Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13 [Up to Cycle 13 (364 days) with 28 days per cycle]
Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).
- Change in Serum Carbohydrate Antigen-125 (CA-125) From Baseline to Cycle 6 [From baseline up to Cycle 6 (168 days) with 28 days per cycle]
CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.
- Change in Serum CA-125 From Baseline to Cycle 13 [From baseline up to Cycle 13 (364 days) with 28 days per cycle]
CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.
- Change in Serum C-reactive Protein (CRP) From Baseline to Cycle 6 [From baseline up to Cycle 6 (168 days) with 28 days per cycle]
CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation.
- Change in Serum CRP From Baseline to Cycle 13 [From baseline up to Cycle 13 (364 days) with 28 days per cycle]
CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation.
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients aged 20 years or older at obtaining informed consent
-
Patients having the normal menstrual cycle (25 to 38 days) in the latest two menses before the final enrollment
-
Patients having a total dysmenorrheal score of at least 3 points in twice of the latest menstruation before the final enrollment
Exclusion Criteria:
-
Patients with ovarian chocolate cysts
-
Patients with fibroid needed to be treated
-
Patients with estrogen-dependent tumors and patients with cervical cancer or suspected cervical cancer
-
Patients with undiagnosed abnormal vaginal bleeding
-
Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease, or coronary artery disease or a history of those diseases
-
Patients aged 35 years or older who smoke at least 15 cigarettes per day
-
Patients with migraine accompanied by prodromata
-
Patients with pulmonary hypertension or valvular heart disease
-
Patients who are regularly taking nutritional products that contain St. John's Wort
-
Patients who underwent surgical treatment for endometriosis within 2 months prior to screening
-
Patients who may need to regularly use analgesics for therapeutic objectives other than relief from the pain of dysmenorrhea during this study (occasional use permitted)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nagoya | Aichi | Japan | 460-0007 | |
| 2 | Nagoya | Aichi | Japan | 460-0011 | |
| 3 | Nagoya | Aichi | Japan | 464-0066 | |
| 4 | Maebashi | Gunma | Japan | 371-0024 | |
| 5 | Takasaki | Gunma | Japan | 370-0883 | |
| 6 | Kobe | Hyogo | Japan | 650-0021 | |
| 7 | Nishinomiya | Hyogo | Japan | 663-8204 | |
| 8 | Yamato | Kanagawa | Japan | 242-0007 | |
| 9 | Yokohama | Kanagawa | Japan | 231-0861 | |
| 10 | Sendai | Miyagi | Japan | 980-0021 | |
| 11 | Sendai | Miyagi | Japan | 981-0933 | |
| 12 | Sendai | Miyagi | Japan | 984-0042 | |
| 13 | Toyonaka | Osaka | Japan | 560-0022 | |
| 14 | Chuo-ku | Tokyo | Japan | 104-0061 | |
| 15 | Hachioji | Tokyo | Japan | 192-0046 | |
| 16 | Machida | Tokyo | Japan | 194-0022 | |
| 17 | Musashino | Tokyo | Japan | 180-0003 | |
| 18 | Ota-ku | Tokyo | Japan | 144-0052 | |
| 19 | Setagaya-ku | Tokyo | Japan | 156-0042 | |
| 20 | Setagaya-ku | Tokyo | Japan | 157-0066 | |
| 21 | Shibuya-ku | Tokyo | Japan | 150-0013 | |
| 22 | Shinagawa-ku | Tokyo | Japan | 140-0013 | |
| 23 | Suginami-ku | Tokyo | Japan | 167-0051 | |
| 24 | Toshima-ku | Tokyo | Japan | 171-0021 | |
| 25 | Osaka | Japan | 530-0013 | ||
| 26 | Osaka | Japan | 534-0014 |
Sponsors and Collaborators
- Bayer
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00461305
Other Study ID Numbers:
- 91616
- 310284
First Posted:
Apr 18, 2007
Last Update Posted:
Jan 24, 2013
Last Verified:
Jan 1, 2013
Keywords provided by ,
,
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Full Analysis Set (FAS) consisted of all patients randomized who received at least one dose of study drug. Patients were analyzed as treated. FAS was the primary analysis set for the efficacy and safety. Per Protocol Set (PPS) was a subgroup of the FAS. The PPS consisted of patients in the FAS without major protocol deviations reported by Cycle 6. |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (13 Cycles) | DRSP 3 mg/EE 30 µg (6 Cycles) |
|---|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) | 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) |
| Period Title: Treatment | ||
| STARTED | 355 | 65 |
| Subjects Dispensed Drugs | 350 | 65 |
| Subjects Received Treatment | 349 | 65 |
| COMPLETED | 254 | 56 |
| NOT COMPLETED | 101 | 9 |
| Period Title: Treatment | ||
| STARTED | 349 | 0 |
| COMPLETED | 254 | 0 |
| NOT COMPLETED | 95 | 0 |
Baseline Characteristics
| Arm/Group Title | DRSP 3 mg/EE 20 µg (13 Cycles) | DRSP 3 mg/EE 30 µg (6 Cycles) | Total |
|---|---|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) | 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) | Total of all reporting groups |
| Overall Participants | 349 | 65 | 414 |
| Age (years) [Mean (Full Range) ] | |||
| Mean (Full Range) [years] |
29.0
|
30.9
|
29.3
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
349
100%
|
65
100%
|
414
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Diagnosis type (participants) [Number] | |||
| Functional dysmenorrhea |
273
78.2%
|
53
81.5%
|
326
78.7%
|
| Organic dysmenorrhea |
76
21.8%
|
12
18.5%
|
88
21.3%
|
| Details of organic dysmenorrhea (participants) [Number] | |||
| Endometriosis |
24
6.9%
|
4
6.2%
|
28
6.8%
|
| Uterine fibroids |
27
7.7%
|
7
10.8%
|
34
8.2%
|
| Uterine adenomyosis |
35
10%
|
8
12.3%
|
43
10.4%
|
| Endometrial polyp |
1
0.3%
|
0
0%
|
1
0.2%
|
| Bicornuate uterus |
3
0.9%
|
0
0%
|
3
0.7%
|
| Multiple endometrial polyp |
1
0.3%
|
0
0%
|
1
0.2%
|
| Uterine enlargement |
1
0.3%
|
0
0%
|
1
0.2%
|
| Average length of menstrual cycle (days) [Mean (Full Range) ] | |||
| Mean (Full Range) [days] |
29.5
|
29.5
|
29.5
|
| Body Mass Index (kg/m^2) [Mean (Full Range) ] | |||
| Mean (Full Range) [kg/m^2] |
20.73
|
20.56
|
20.70
|
Outcome Measures
| Title | Number of Participants With Intracyclic Bleeding at Cycle 6 |
|---|---|
| Description | Intracyclic bleedings were defined as bleedings while a participant takes active tablets. |
| Time Frame | Up to Cycle 6 (168 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with data at Cycle 6) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (6 Cycles) | DRSP 3 mg/EE 30 µg (6 Cycles) |
|---|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) | 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) |
| Measure Participants | 299 | 56 |
| Number [participants] |
40
11.5%
|
4
6.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DRSP 3 mg/EE 20 µg (6 Cycles) |
|---|---|---|
| Comments | Exact 95% confident intervals were calculated using F-distribution by treatment group. If the upper confidence limit is lower than 27.56% (threshold incidence), the treatment arm will be concluded to be acceptable. No group comparison was planned. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Incidence on one treatment arm |
| Estimated Value | 13.4 | |
| Confidence Interval |
(2-Sided) 95% 9.73 to 17.77 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | No group comparison were planned. Binomial parameter on each treatment arm was estimated by exact method. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | DRSP 3 mg/EE 30 µg (6 Cycles) |
|---|---|---|
| Comments | Exact 95% confident intervals were calculated using F-distribution by treatment group. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Incidence on one treatment arm |
| Estimated Value | 7.1 | |
| Confidence Interval |
() 95% 1.98 to 17.29 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 |
|---|---|
| Description | Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change. |
| Time Frame | From baseline up to Cycle 6 (168 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with data at Cycle 6) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (6 Cycles) | DRSP 3 mg/EE 30 µg (6 Cycles) |
|---|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) | 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) |
| Measure Participants | 272 | 54 |
| -6 (change in total dysmenorrhea scores) |
5
1.4%
|
2
3.1%
|
| -5 (change in total dysmenorrhea scores) |
22
6.3%
|
3
4.6%
|
| -4 (change in total dysmenorrhea scores) |
41
11.7%
|
8
12.3%
|
| -3 (change in total dysmenorrhea scores) |
70
20.1%
|
13
20%
|
| -2 (change in total dysmenorrhea scores) |
71
20.3%
|
10
15.4%
|
| -1 (change in total dysmenorrhea scores) |
30
8.6%
|
12
18.5%
|
| 0 (change in total dysmenorrhea scores) |
25
7.2%
|
4
6.2%
|
| 1 (change in total dysmenorrhea scores) |
4
1.1%
|
2
3.1%
|
| 2 (change in total dysmenorrhea scores) |
4
1.1%
|
0
0%
|
| 3 (change in total dysmenorrhea scores) |
0
0%
|
0
0%
|
| 4 (change in total dysmenorrhea scores) |
0
0%
|
0
0%
|
| 5 (change in total dysmenorrhea scores) |
0
0%
|
0
0%
|
| 6 (change in total dysmenorrhea scores) |
0
0%
|
0
0%
|
| Title | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13 |
|---|---|
| Description | Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change. |
| Time Frame | From baseline up to Cycle 13 (364 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (13 Cycles) |
|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) |
| Measure Participants | 242 |
| -6 (change in total dysmenorrhea scores) |
4
1.1%
|
| -5 (change in total dysmenorrhea scores) |
22
6.3%
|
| -4 (change in total dysmenorrhea scores) |
47
13.5%
|
| -3 (change in total dysmenorrhea scores) |
68
19.5%
|
| -2 (change in total dysmenorrhea scores) |
44
12.6%
|
| -1 (change in total dysmenorrhea scores) |
32
9.2%
|
| 0 (change in total dysmenorrhea scores) |
12
3.4%
|
| 1 (change in total dysmenorrhea scores) |
11
3.2%
|
| 2 (change in total dysmenorrhea scores) |
2
0.6%
|
| 3 (change in total dysmenorrhea scores) |
0
0%
|
| 4 (change in total dysmenorrhea scores) |
0
0%
|
| 5 (change in total dysmenorrhea scores) |
0
0%
|
| 6 (change in total dysmenorrhea scores) |
0
0%
|
| Title | Distribution of Total Dysmenorrhea Score at Cycle 6 |
|---|---|
| Description | Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest. |
| Time Frame | Up to Cycle 6 (168 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with data at Cycle 6) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (6 Cycles) | DRSP 3 mg/EE 30 µg (6 Cycles) |
|---|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) | 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) |
| Measure Participants | 272 | 54 |
| 0 |
65
18.6%
|
13
20%
|
| 1 |
79
22.6%
|
16
24.6%
|
| 2 |
49
14%
|
9
13.8%
|
| 3 |
42
12%
|
8
12.3%
|
| 4 |
19
5.4%
|
3
4.6%
|
| 5 |
17
4.9%
|
4
6.2%
|
| 6 |
1
0.3%
|
1
1.5%
|
| Title | Distribution of Total Dysmenorrhea Score at Cycle 13 |
|---|---|
| Description | Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest. |
| Time Frame | Up to Cycle 13 (364 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (13 Cycles) |
|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) |
| Measure Participants | 242 |
| 0 |
73
20.9%
|
| 1 |
66
18.9%
|
| 2 |
41
11.7%
|
| 3 |
24
6.9%
|
| 4 |
24
6.9%
|
| 5 |
13
3.7%
|
| 6 |
1
0.3%
|
| Title | Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6 |
|---|---|
| Description | Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities). |
| Time Frame | Up to Cycle 6 (168 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with data at Cycle 6) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (6 Cycles) | DRSP 3 mg/EE 30 µg (6 Cycles) |
|---|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) | 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) |
| Measure Participants | 272 | 54 |
| none |
75
21.5%
|
14
21.5%
|
| mild |
119
34.1%
|
19
29.2%
|
| moderate |
59
16.9%
|
16
24.6%
|
| severe |
19
5.4%
|
5
7.7%
|
| Title | Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13 |
|---|---|
| Description | Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities). |
| Time Frame | Up to Cycle 13 (364 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (13 Cycles) |
|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) |
| Measure Participants | 242 |
| none |
78
22.3%
|
| mild |
106
30.4%
|
| moderate |
47
13.5%
|
| severe |
11
3.2%
|
| Title | Distribution of Severity of Lumbago During Menstruation at Cycle 6 |
|---|---|
| Description | Severity of lumbago during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities). |
| Time Frame | Up to Cycle 6 (168 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with data at Cycle 6) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (6 Cycles) | DRSP 3 mg/EE 30 µg (6 Cycles) |
|---|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) | 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) |
| Measure Participants | 272 | 54 |
| none |
154
44.1%
|
21
32.3%
|
| mild |
88
25.2%
|
29
44.6%
|
| moderate |
26
7.4%
|
2
3.1%
|
| severe |
4
1.1%
|
2
3.1%
|
| Title | Distribution of Severity of Lumbago During Menstruation at Cycle 13 |
|---|---|
| Description | Severity of lumbago during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities). |
| Time Frame | Up to Cycle 13 (364 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (13 Cycles) |
|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) |
| Measure Participants | 242 |
| none |
148
42.4%
|
| mild |
72
20.6%
|
| moderate |
19
5.4%
|
| severe |
3
0.9%
|
| Title | Distribution of Severity of Headache During Menstruation at Cycle 6 |
|---|---|
| Description | Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities). |
| Time Frame | Up to Cycle 6 (168 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with data at Cycle 6) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (6 Cycles) | DRSP 3 mg/EE 30 µg (6 Cycles) |
|---|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) | 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) |
| Measure Participants | 272 | 54 |
| none |
187
53.6%
|
37
56.9%
|
| mild |
41
11.7%
|
4
6.2%
|
| moderate |
29
8.3%
|
11
16.9%
|
| severe |
15
4.3%
|
2
3.1%
|
| Title | Distribution of Severity of Headache During Menstruation at Cycle 13 |
|---|---|
| Description | Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities). |
| Time Frame | Up to Cycle 13 (364 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (13 Cycles) |
|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) |
| Measure Participants | 242 |
| none |
168
48.1%
|
| mild |
38
10.9%
|
| moderate |
30
8.6%
|
| severe |
6
1.7%
|
| Title | Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6 |
|---|---|
| Description | Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities). |
| Time Frame | Up to Cycle 6 (168 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with data at Cycle 6) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (6 Cycles) | DRSP 3 mg/EE 30 µg (6 Cycles) |
|---|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) | 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) |
| Measure Participants | 272 | 54 |
| none |
251
71.9%
|
51
78.5%
|
| mild |
14
4%
|
1
1.5%
|
| moderate |
4
1.1%
|
2
3.1%
|
| severe |
3
0.9%
|
0
0%
|
| Title | Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13 |
|---|---|
| Description | Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities). |
| Time Frame | Up to Cycle 13 (364 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (13 Cycles) |
|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) |
| Measure Participants | 242 |
| none |
229
65.6%
|
| mild |
11
3.2%
|
| moderate |
2
0.6%
|
| severe |
0
0%
|
| Title | Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6 |
|---|---|
| Description | Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest. |
| Time Frame | Up to Cycle 6 (168 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with data at Cycle 6) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (6 Cycles) | DRSP 3 mg/EE 30 µg (6 Cycles) |
|---|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) | 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) |
| Measure Participants | 271 | 54 |
| 0 |
202
57.9%
|
34
52.3%
|
| 1 |
52
14.9%
|
13
20%
|
| 2 |
11
3.2%
|
4
6.2%
|
| 3 |
2
0.6%
|
1
1.5%
|
| 4 |
2
0.6%
|
1
1.5%
|
| 5 |
2
0.6%
|
0
0%
|
| 6 |
0
0%
|
1
1.5%
|
| Title | Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13 |
|---|---|
| Description | Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest. |
| Time Frame | Up to Cycle 13 (364 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (13 Cycles) |
|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) |
| Measure Participants | 242 |
| 0 |
177
50.7%
|
| 1 |
49
14%
|
| 2 |
12
3.4%
|
| 3 |
2
0.6%
|
| 4 |
2
0.6%
|
| 5 |
0
0%
|
| 6 |
0
0%
|
| Title | Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 6 |
|---|---|
| Description | VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced). |
| Time Frame | From baseline up to Cycle 6 (168 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with data at Cycle 6) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (6 Cycles) | DRSP 3 mg/EE 30 µg (6 Cycles) |
|---|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) | 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) |
| Measure Participants | 272 | 54 |
| Mean (Full Range) [scores on a scale] |
-37.2
|
-31.9
|
| Title | Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 13 |
|---|---|
| Description | VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced). |
| Time Frame | From baseline up to Cycle 13 (364 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (13 Cycles) |
|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) |
| Measure Participants | 242 |
| Mean (Full Range) [scores on a scale] |
-41.6
|
| Title | Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 6 |
|---|---|
| Description | VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced). |
| Time Frame | From baseline up to Cycle 6 (168 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with data at Cycle 6) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (6 Cycles) | DRSP 3 mg/EE 30 µg (6 Cycles) |
|---|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) | 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) |
| Measure Participants | 271 | 54 |
| Mean (Full Range) [scores on a scale] |
6.7
|
12.2
|
| Title | Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 13 |
|---|---|
| Description | VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced). |
| Time Frame | From baseline up to Cycle 13 (364 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (13 Cycles) |
|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) |
| Measure Participants | 242 |
| Mean (Full Range) [scores on a scale] |
6.2
|
| Title | Number of Any Bleeding Episodes From Cycle 1 to Cycle 6 |
|---|---|
| Description | Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days). |
| Time Frame | Up to Cycle 6 (168 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with the defined data, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (6 Cycles) | DRSP 3 mg/EE 30 µg (6 Cycles) |
|---|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) | 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) |
| Measure Participants | 326 | 60 |
| Reference period 1 |
3.3
|
3.4
|
| Reference period 2 |
3.3
|
3.1
|
| Title | Number of Any Bleeding Episodes From Cycle 1 to Cycle 13 |
|---|---|
| Description | Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days), reference period 3 is from Cycle 7 to Cycle 9 (the 3rd 90 days), reference period 4 is from Cycle 10 to Cycle 12 (the 4th 90 days). |
| Time Frame | Up to Cycle 13 (364 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with the defined data, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (13 Cycles) |
|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) |
| Measure Participants | 333 |
| Reference period 1 |
3.2
|
| Reference period 2 |
3.5
|
| Reference period 3 |
3.1
|
| Reference period 4 |
3.2
|
| Title | Number of Any Bleeding Days From Cycle 1 to Cycle 6 |
|---|---|
| Description | Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days). |
| Time Frame | Up to Cycle 6 (168 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with the defined data, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (6 Cycles) | DRSP 3 mg/EE 30 µg (6 Cycles) |
|---|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) | 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) |
| Measure Participants | 326 | 60 |
| Reference period 1 |
30.7
|
28.9
|
| Reference period 2 |
19.3
|
19.9
|
| Title | Number of Any Bleeding Days From Cycle 1 to Cycle 13 |
|---|---|
| Description | Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 4 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days), reference period 3 is from Cycle 7 to Cycle 9 (the 3rd 90 days), reference period 4 is from Cycle 10 to Cycle 12 (the 4th 90 days). |
| Time Frame | Up to Cycle 13 (364 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with the defined data, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (13 Cycles) |
|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) |
| Measure Participants | 337 |
| Reference period 1 |
30.6
|
| Reference period 2 |
19.8
|
| Reference period 3 |
21.2
|
| Reference period 4 |
17.7
|
| Title | Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6 |
|---|---|
| Description | Intracyclic bleedings were defined as bleedings while a participant takes active tablets. |
| Time Frame | Up to Cycle 6 (168 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (6 Cycles) | DRSP 3 mg/EE 30 µg (6 Cycles) |
|---|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) | 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) |
| Measure Participants | 341 | 62 |
| Cycle 1 |
94
26.9%
|
19
29.2%
|
| Cycle 2 |
38
10.9%
|
8
12.3%
|
| Cycle 3 |
45
12.9%
|
8
12.3%
|
| Cycle 4 |
33
9.5%
|
3
4.6%
|
| Cycle 5 |
40
11.5%
|
5
7.7%
|
| Cycle 6 |
29
8.3%
|
4
6.2%
|
| Title | Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13 |
|---|---|
| Description | Intracyclic bleedings were defined as bleedings while a participant takes active tablets. |
| Time Frame | Up to Cycle 13 (364 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (13 Cycles) |
|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) |
| Measure Participants | 343 |
| Cycle 1 |
93
26.6%
|
| Cycle 2 |
38
10.9%
|
| Cycle 3 |
45
12.9%
|
| Cycle 4 |
33
9.5%
|
| Cycle 5 |
41
11.7%
|
| Cycle 6 |
40
11.5%
|
| Cycle 7 |
114
32.7%
|
| Cycle 8 |
24
6.9%
|
| Cycle 9 |
24
6.9%
|
| Cycle 10 |
24
6.9%
|
| Cycle 11 |
21
6%
|
| Cycle 12 |
23
6.6%
|
| Cycle 13 |
31
8.9%
|
| Title | Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6 |
|---|---|
| Description | Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets. |
| Time Frame | Up to Cycle 6 (168 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (6 Cycles) | DRSP 3 mg/EE 30 µg (6 Cycles) |
|---|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) | 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) |
| Measure Participants | 341 | 62 |
| Cycle 1 |
276
79.1%
|
54
83.1%
|
| Cycle 2 |
310
88.8%
|
57
87.7%
|
| Cycle 3 |
302
86.5%
|
58
89.2%
|
| Cycle 4 |
290
83.1%
|
54
83.1%
|
| Cycle 5 |
279
79.9%
|
54
83.1%
|
| Cycle 6 |
185
53%
|
52
80%
|
| Title | Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13 |
|---|---|
| Description | Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets. |
| Time Frame | Up to Cycle 13 (364 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (13 Cycles) |
|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) |
| Measure Participants | 343 |
| Cycle 1 |
274
78.5%
|
| Cycle 2 |
314
90%
|
| Cycle 3 |
307
88%
|
| Cycle 4 |
295
84.5%
|
| Cycle 5 |
289
82.8%
|
| Cycle 6 |
285
81.7%
|
| Cycle 7 |
229
65.6%
|
| Cycle 8 |
259
74.2%
|
| Cycle 9 |
245
70.2%
|
| Cycle 10 |
250
71.6%
|
| Cycle 11 |
246
70.5%
|
| Cycle 12 |
243
69.6%
|
| Cycle 13 |
241
69.1%
|
| Title | Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6 |
|---|---|
| Description | Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding). |
| Time Frame | Up to Cycle 6 (168 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (6 Cycles) | DRSP 3 mg/EE 30 µg (6 Cycles) |
|---|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) | 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) |
| Measure Participants | 349 | 65 |
| Cycle 1 |
90.3
25.9%
|
89.5
137.7%
|
| Cycle 2 |
97.4
27.9%
|
100.0
153.8%
|
| Cycle 3 |
91.1
26.1%
|
100.0
153.8%
|
| Cycle 4 |
87.9
25.2%
|
100.0
153.8%
|
| Cycle 5 |
87.8
25.2%
|
80.0
123.1%
|
| Cycle 6 |
92.5
26.5%
|
100.0
153.8%
|
| Title | Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13 |
|---|---|
| Description | Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding). |
| Time Frame | Up to Cycle 13 (364 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (13 Cycles) |
|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) |
| Measure Participants | 349 |
| Cycle 1 |
90.3
25.9%
|
| Cycle 2 |
97.4
27.9%
|
| Cycle 3 |
91.1
26.1%
|
| Cycle 4 |
87.9
25.2%
|
| Cycle 5 |
87.8
25.2%
|
| Cycle 6 |
92.5
26.5%
|
| Cycle 7 |
90.4
25.9%
|
| Cycle 8 |
100.0
28.7%
|
| Cycle 9 |
87.5
25.1%
|
| Cycle 10 |
100.0
28.7%
|
| Cycle 11 |
100.0
28.7%
|
| Cycle 12 |
100.0
28.7%
|
| Cycle 13 |
90.3
25.9%
|
| Title | Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6 |
|---|---|
| Description | Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding). |
| Time Frame | Up to Cycle 6 (168 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (6 Cycles) | DRSP 3 mg/EE 30 µg (6 Cycles) |
|---|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) | 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) |
| Measure Participants | 349 | 65 |
| Cycle 1 |
90.1
25.8%
|
87.0
133.8%
|
| Cycle 2 |
90.8
26%
|
94.7
145.7%
|
| Cycle 3 |
91.2
26.1%
|
87.9
135.2%
|
| Cycle 4 |
92.2
26.4%
|
92.6
142.5%
|
| Cycle 5 |
92.7
26.6%
|
88.9
136.8%
|
| Cycle 6 |
90.9
26%
|
88.5
136.2%
|
| Title | Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13 |
|---|---|
| Description | Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding). |
| Time Frame | Up to Cycle 13 (364 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (13 Cycles) |
|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) |
| Measure Participants | 349 |
| Cycle 1 |
90.1
25.8%
|
| Cycle 2 |
90.8
26%
|
| Cycle 3 |
91.2
26.1%
|
| Cycle 4 |
92.2
26.4%
|
| Cycle 5 |
92.7
26.6%
|
| Cycle 6 |
90.9
26%
|
| Cycle 7 |
91.3
26.2%
|
| Cycle 8 |
91.1
26.1%
|
| Cycle 9 |
91.0
26.1%
|
| Cycle 10 |
90.8
26%
|
| Cycle 11 |
91.9
26.3%
|
| Cycle 12 |
93.8
26.9%
|
| Cycle 13 |
93.8
26.9%
|
| Title | Change in Serum Carbohydrate Antigen-125 (CA-125) From Baseline to Cycle 6 |
|---|---|
| Description | CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor. |
| Time Frame | From baseline up to Cycle 6 (168 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS(Participants with data at Cycle 6) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (6 Cycles) | DRSP 3 mg/EE 30 µg (6 Cycles) |
|---|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) | 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) |
| Measure Participants | 281 | 56 |
| Mean (Full Range) [Units/mL] |
-4.33
|
-5.50
|
| Title | Change in Serum CA-125 From Baseline to Cycle 13 |
|---|---|
| Description | CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor. |
| Time Frame | From baseline up to Cycle 13 (364 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (13 Cycles) |
|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) |
| Measure Participants | 254 |
| Mean (Full Range) [Units/mL] |
-4.66
|
| Title | Change in Serum C-reactive Protein (CRP) From Baseline to Cycle 6 |
|---|---|
| Description | CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation. |
| Time Frame | From baseline up to Cycle 6 (168 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS(Participants with data at Cycle 6) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (6 Cycles) | DRSP 3 mg/EE 30 µg (6 Cycles) |
|---|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) | 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) |
| Measure Participants | 281 | 56 |
| Mean (Full Range) [mg/dL] |
0.159
|
0.000
|
| Title | Change in Serum CRP From Baseline to Cycle 13 |
|---|---|
| Description | CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation. |
| Time Frame | From baseline up to Cycle 13 (364 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (13 Cycles) |
|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) |
| Measure Participants | 254 |
| Mean (Full Range) [mg/dL] |
0.014
|
| Title | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6 |
|---|---|
| Description | Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest. |
| Time Frame | Baseline and up to Cycle 6 (168 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (6 Cycles) | DRSP 3 mg/EE 30 µg (6 Cycles) |
|---|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) | 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) |
| Measure Participants | 349 | 65 |
| age: < 30 years |
-2.4
(1.68)
|
-2.2
(1.64)
|
| age: >= 30 years |
-2.2
(1.52)
|
-2.1
(1.69)
|
| weight: < 50 kg |
-2.0
(1.58)
|
-2.3
(1.76)
|
| weight: >= 50kg |
-2.5
(1.61)
|
-2.0
(1.60)
|
| functional dysmenorrhea |
-2.4
(1.64)
|
-2.3
(1.54)
|
| organic dysmenorrhea |
-2.0
(1.45)
|
-1.3
(1.91)
|
| with medical surgical history |
-2.3
(1.61)
|
-2.0
(1.69)
|
| without medical surgical history |
-2.4
(1.54)
|
-2.4
(1.60)
|
| with previous medication |
-2.3
(1.61)
|
-2.1
(1.66)
|
| with pregnancy history |
-2.2
(1.67)
|
-2.1
(1.68)
|
| with birth history |
-2.0
(1.71)
|
-2.4
(1.83)
|
| total dysmenorrhea score at baseline 3/4 |
-1.9
(1.37)
|
-1.9
(1.37)
|
| total dysmenorrhea score at baseline 5/6 |
-3.0
(1.73)
|
-2.6
(2.04)
|
| Title | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13 |
|---|---|
| Description | Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest. |
| Time Frame | Baseline and up to Cycle 13 (364 days) with 28 days per cycle |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles) |
| Arm/Group Title | DRSP 3 mg/EE 20 µg (13 Cycles) |
|---|---|
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) |
| Measure Participants | 349 |
| age: < 30 years |
-2.5
(1.67)
|
| age: >= 30 years |
-2.4
(1.70)
|
| weight: < 50 kg |
-2.1
(1.68)
|
| weight: >= 50kg |
-2.7
(1.65)
|
| functional dysmenorrhea |
-2.6
(1.70)
|
| organic dysmenorrhea |
-2.1
(1.59)
|
| with medical surgical history |
-2.5
(1.72)
|
| without medical surgical history |
-2.5
(1.64)
|
| with previous medication |
-2.5
(1.69)
|
| with pregnancy history |
-2.1
(1.75)
|
| with birth history |
-1.9
(1.76)
|
| total dysmenorrhea score at baseline 3/4 |
-2.0
(1.48)
|
| total dysmenorrhea score at baseline 5/6 |
-3.2
(1.75)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | DRSP 3 mg/EE 20 µg (13 Cycles) | DRSP 3 mg/EE 30 µg (6 Cycles) | ||
| Arm/Group Description | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) | 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) | ||
All Cause Mortality |
||||
| DRSP 3 mg/EE 20 µg (13 Cycles) | DRSP 3 mg/EE 30 µg (6 Cycles) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| DRSP 3 mg/EE 20 µg (13 Cycles) | DRSP 3 mg/EE 30 µg (6 Cycles) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/355 (1.4%) | 0/65 (0%) | ||
| Infections and infestations | ||||
| Appendicitis | 1/355 (0.3%) | 1 | 0/65 (0%) | 0 |
| Enteritis infectious | 1/355 (0.3%) | 1 | 0/65 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Endometrial cancer | 1/355 (0.3%) | 1 | 0/65 (0%) | 0 |
| Nervous system disorders | ||||
| Facial palsy | 1/355 (0.3%) | 1 | 0/65 (0%) | 0 |
| Reproductive system and breast disorders | ||||
| Dysmenorrhoea | 1/355 (0.3%) | 1 | 0/65 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| DRSP 3 mg/EE 20 µg (13 Cycles) | DRSP 3 mg/EE 30 µg (6 Cycles) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 335/355 (94.4%) | 63/65 (96.9%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain lower | 53/355 (14.9%) | 68 | 5/65 (7.7%) | 6 |
| Abdominal pain upper | 13/355 (3.7%) | 17 | 5/65 (7.7%) | 5 |
| Constipation | 19/355 (5.4%) | 20 | 1/65 (1.5%) | 1 |
| Diarrhoea | 24/355 (6.8%) | 35 | 3/65 (4.6%) | 3 |
| Nausea | 128/355 (36.1%) | 217 | 25/65 (38.5%) | 37 |
| Vomiting | 22/355 (6.2%) | 24 | 4/65 (6.2%) | 4 |
| Immune system disorders | ||||
| Seasonal allergy | 35/355 (9.9%) | 38 | 4/65 (6.2%) | 4 |
| Infections and infestations | ||||
| Nasopharyngitis | 182/355 (51.3%) | 339 | 34/65 (52.3%) | 44 |
| Vulvovaginal candidiasis | 19/355 (5.4%) | 20 | 0/65 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Post procedural haemorrhage | 55/355 (15.5%) | 82 | 11/65 (16.9%) | 11 |
| Procedural pain | 19/355 (5.4%) | 25 | 1/65 (1.5%) | 1 |
| Investigations | ||||
| Blood triglycerides increased | 29/355 (8.2%) | 33 | 2/65 (3.1%) | 3 |
| Plasminogen increased | 18/355 (5.1%) | 18 | 7/65 (10.8%) | 7 |
| Protein S decreased | 9/355 (2.5%) | 9 | 6/65 (9.2%) | 6 |
| Thrombin-antithrombin III complex increased | 35/355 (9.9%) | 39 | 1/65 (1.5%) | 1 |
| Blood alkaline phosphatase decreased | 3/355 (0.8%) | 3 | 4/65 (6.2%) | 4 |
| Coagulation test abnormal | 70/355 (19.7%) | 71 | 12/65 (18.5%) | 12 |
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 25/355 (7%) | 34 | 2/65 (3.1%) | 2 |
| Nervous system disorders | ||||
| Headache | 215/355 (60.6%) | 679 | 39/65 (60%) | 81 |
| Reproductive system and breast disorders | ||||
| Dysmenorrhoea | 124/355 (34.9%) | 268 | 20/65 (30.8%) | 42 |
| Menorrhagia | 16/355 (4.5%) | 21 | 4/65 (6.2%) | 7 |
| Metrorrhagia | 97/355 (27.3%) | 235 | 9/65 (13.8%) | 23 |
| Breast discomfort | 13/355 (3.7%) | 15 | 5/65 (7.7%) | 5 |
| Genital haemorrhage | 97/355 (27.3%) | 194 | 14/65 (21.5%) | 26 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Rhinitis allergic | 22/355 (6.2%) | 24 | 3/65 (4.6%) | 3 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Sponsor will confirm the contents before disclosure.
Results Point of Contact
| Name/Title | Therapeutic Area Head |
|---|---|
| Organization | BAYER |
| Phone | |
| clinical-trials-contact@bayerhealthcare.com |
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00461305
Other Study ID Numbers:
- 91616
- 310284
First Posted:
Apr 18, 2007
Last Update Posted:
Jan 24, 2013
Last Verified:
Jan 1, 2013