Efficacy and Safety of Two Flexible Extended Regimens of BAY86-5300 (SH T00186D) in Comparison With the Conventional Regimen of YAZ
Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT00567164
Collaborator
(none)
1,887
85
3
25
22.2
0.9
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether the study drug is safe and effective.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
The primary efficacy parameter is the number of observed unintended pregnancy during 1 year of treatment. Secondary efficacy parameter include bleeding parameters and menstrual related symptoms Safety parameters included assessment of adverse events, laboratory evaluations.
Study Design
Study Type:
Interventional
Actual Enrollment
:
1887 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Multicenter, Open-label, Three-arm, Active-controlled Study to Assess the Efficacy and Safety of the Oral Contraceptive SH T00186D (0.02 mg Ethinyl Estradiol as Betadex Clathrate and 3 mg Drospirenone) in Two Flexible Extended Regimens and a Conventional Regimen of YAZ in 1756 Healthy Females for 1 Year
Study Start Date
:
Oct 1, 2007
Actual Primary Completion Date
:
Nov 1, 2009
Actual Study Completion Date
:
Nov 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Flexible (extended) regimen no. 1 of EE20/DRSP (BAY86-5300) Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment |
Drug: EE20/DRSP (BAY86-5300)
Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone
Other Names:
|
| Experimental: Flexible (extended) regimen no. 2 of EE20/DRSP (BAY86-5300) Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. |
Drug: EE20/DRSP (BAY86-5300)
Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone
Other Names:
|
| Active Comparator: Conventional regimen of EE20/DRSP (YAZ, BAY86-5300) 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of tablets without active substance (together resulting in one cycle of 24+4 standard treatment). 13 withdrawal bleeding episodes during one year of treatment were expected. |
Drug: EE20/DRSP (YAZ, BAY86-5300)
Fixed package per cycle containing combination tablets containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone (24 per cycle) + tablets without active substance (4 per cycle)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Pearl Index [Up to 1 year]
The Pearl Index (PI) is the number of pregnancies per 100 woman years. The PI is obtained by dividing the number of pregnancies during treatment (conception date on/after the 1st day of treatment and not later than last day of treatment +14 days) by the treatment exposure time (in 100 women years) that the women were under risk of getting pregnant. The Pearl Index was not calculated individually for either the Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) treatment arm, nor for the Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) treatment arm, because the low sample size in these treatment arms (approximately. 200 subjects per group) did not allow a reliable PI calculation of these groups alone.
Secondary Outcome Measures
- Number of Bleeding Days (Including Spotting Days) [Up to 1 year]
Number of days per participant with bleeding or spotting
- Number of Bleeding Days (Excluding Spotting Days) [Up to 1 year]
Number of days per participant with bleeding (excluding spotting days)
- Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 1. [Day 1 to Day 90]
Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 1. Reference period 1 (Day 1 to Day 90) was a 90 day period starting with the initial intake of study medication (protocol-specified to occur on first day of menstrual or withdrawal bleeding after screening). Therefore, the first 90-day reference period contains additional bleeding days (associated with the menstrual cycle prior to the start of study medication) when compared to any other reference period.
- Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 2. [Day 91 to Day 180]
Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 2. Reference period 2 (Day 91 to Day 180) was a 90-day period that started with the intake of study medication at the beginning of Cycle 4.
- Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 3 [Day 181 to Day 270]
Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 3. Reference period 3 (Day 181 to Day 270) was a 90-day period that started with the intake of study medication at the beginning of Cycle 7.
- Number of Days With Bleeding/ (Including and Excluding Spotting) Within 90-day Reference Period 4 [Day 271 to Day 360]
Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 4. Reference period 4 (Day 271 to Day 360) was a 90-day period that started with the intake of study medication at the beginning of Cycle 10.
- Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 1 [Up to 1 year]
A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
- Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 2 [Up to 1 year]
A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
- Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 3 [Up to 1 year]
A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
- Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 4 [Up to 1 year]
A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
- Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 5 [Up to 1 year]
A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
- Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 6 [Up to 1 year]
A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
- Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 7 [Up to 1 year]
A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
- Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 8 [Up to 1 year]
A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
- Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 9 [Up to 1 year]
A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
- Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 10 [Up to 1 year]
A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
- Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 11 [Up to 1 year]
A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
- Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 12 [Up to 1 year]
A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
- Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 13 [Up to 1 year]
A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. There were no participants who provided bleeding data for cycle 13 in the Flexible (extended) regimen no.1 of EE20/DRSP (BAY86-5300), although one women did receive 13 cycles of treatment.
- Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 14 [Up to 1 year]
A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. There were no participants who received treatment in cycle 14 in the Flexible (extended) regimen no.1 of EE20/DRSP (BAY86-5300). There were no participants who provided bleeding data for cycle 14 in the Flexible (extended) regimen no.2 of EE20/DRSP (BAY86-5300), although one woman did receive 14 cycles of treatment.
- Number of Intracyclic Bleeding Days [Up to 1 year]
Intracyclic bleeding was considered any bleeding/spotting that occurred between withdrawal bleedings.
- Number of Scheduled and Unscheduled Bleeding Days [Up to 1 year]
Scheduled bleeding is any bleeding/spotting (bl/sp) that occurs during the tablet free interval through the next 4 days of the subsequent treatment cycle. Unscheduled bleeding is any bl/sp that occurs while taking active hormones, except for bl/sp that occurs during the tablet free interval through day 4 of the subsequent treatment cycle or bl/sp on days 1-7 of treatment cycle 1.
- Length of Cycles [Up to 1 year]
Cycle length per cycle. For the flexible and stop and go extended treatment arms, a treatment cycle started with the first day of pill intake after a tablet-free interval and ended with the last day of the subsequent tablet-free interval. A tablet-free interval (treatment withdrawal) was defined as at least 3 consecutive days without tablet intake. For the standard 24+4 treatment arm, a new cycle started each time a new blister pack of medication was started.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Healthy women between 18 and 45 requesting oral contraception. Smokers may not exceed 35 years of age.
Exclusion Criteria:
- The use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Montgomery | Alabama | United States | 36116 | |
| 2 | Chandler | Arizona | United States | 85224 | |
| 3 | Mesa | Arizona | United States | 85203 | |
| 4 | Mesa | Arizona | United States | 85213 | |
| 5 | Phoenix | Arizona | United States | 85031 | |
| 6 | Tempe | Arizona | United States | 85283 | |
| 7 | Tucson | Arizona | United States | 85712 | |
| 8 | Tucson | Arizona | United States | 85741 | |
| 9 | Anaheim | California | United States | 92801-2811 | |
| 10 | Beverly Hills | California | United States | 90212 | |
| 11 | Pacific Palisades | California | United States | 90272 | |
| 12 | San Diego | California | United States | 92103 | |
| 13 | San Diego | California | United States | 92108 | |
| 14 | Santa Ana | California | United States | 92705 | |
| 15 | Vallejo | California | United States | 94589 | |
| 16 | Colorado Springs | Colorado | United States | 80909 | |
| 17 | Denver | Colorado | United States | 80218 | |
| 18 | Greenwood Village | Colorado | United States | 80111 | |
| 19 | Littleton | Colorado | United States | 80123 | |
| 20 | Waterbury | Connecticut | United States | 06708 | |
| 21 | Boynton Beach | Florida | United States | 33472-2952 | |
| 22 | Brooksville | Florida | United States | 34613 | |
| 23 | Clearwater | Florida | United States | 33759 | |
| 24 | Coral Gables | Florida | United States | 33134 | |
| 25 | Crystal River | Florida | United States | 34429 | |
| 26 | Jacksonville | Florida | United States | 32259 | |
| 27 | Lake Worth | Florida | United States | 33461 | |
| 28 | Miami | Florida | United States | 33186 | |
| 29 | Naples | Florida | United States | 34102 | |
| 30 | North Miami | Florida | United States | 33161 | |
| 31 | Pembroke Pines | Florida | United States | 33024 | |
| 32 | Plantation | Florida | United States | 33313 | |
| 33 | South Miami | Florida | United States | 33143 | |
| 34 | St. Petersburg | Florida | United States | 33709 | |
| 35 | West Palm Beach | Florida | United States | 33409 | |
| 36 | Atlanta | Georgia | United States | 30328 | |
| 37 | Decatur | Georgia | United States | 30034 | |
| 38 | Boise | Idaho | United States | 83702 | |
| 39 | Boise | Idaho | United States | 83704 | |
| 40 | Idaho Falls | Idaho | United States | 83404 | |
| 41 | Champaign | Illinois | United States | 61820 | |
| 42 | Chicago | Illinois | United States | 60612 | |
| 43 | Newburgh | Indiana | United States | 47630 | |
| 44 | Wichita | Kansas | United States | 67207 | |
| 45 | Lexington | Kentucky | United States | 40509 | |
| 46 | Marrero | Louisiana | United States | 70072 | |
| 47 | Paw Paw | Michigan | United States | 49079 | |
| 48 | Chesterfield | Missouri | United States | 63017 | |
| 49 | Kansas City | Missouri | United States | 64114 | |
| 50 | Lincoln | Nebraska | United States | 68510 | |
| 51 | Las Vegas | Nevada | United States | 89104 | |
| 52 | Las Vegas | Nevada | United States | 89109 | |
| 53 | LasVegas | Nevada | United States | 89106 | |
| 54 | Moorestown | New Jersey | United States | 08057 | |
| 55 | New Brunswick | New Jersey | United States | 08901 | |
| 56 | Rochester | New York | United States | 14618 | |
| 57 | Durham | North Carolina | United States | 27713 | |
| 58 | New Bern | North Carolina | United States | 28562 | |
| 59 | Winston-Salem | North Carolina | United States | 27103 | |
| 60 | Bismarck | North Dakota | United States | 58501 | |
| 61 | Cleveland | Ohio | United States | 44122 | |
| 62 | Columbus | Ohio | United States | 43213 | |
| 63 | Oklahoma City | Oklahoma | United States | 73112 | |
| 64 | Portland | Oregon | United States | 97239-3011 | |
| 65 | Portland | Oregon | United States | 97239 | |
| 66 | Jenkintown | Pennsylvania | United States | 19046 | |
| 67 | Philadelphia | Pennsylvania | United States | 19114 | |
| 68 | Pittsburgh | Pennsylvania | United States | 15206 | |
| 69 | Columbia | South Carolina | United States | 29201 | |
| 70 | Mt. Pleasant | South Carolina | United States | 29464 | |
| 71 | Chattanooga | Tennessee | United States | 37404 | |
| 72 | Jackson | Tennessee | United States | 38305-3618 | |
| 73 | Knoxville | Tennessee | United States | 37920 | |
| 74 | Memphis | Tennessee | United States | 38120 | |
| 75 | Nashville | Tennessee | United States | 37203 | |
| 76 | Colleyville | Texas | United States | 76034 | |
| 77 | Corpus Christi | Texas | United States | 78414 | |
| 78 | Dallas | Texas | United States | 75234 | |
| 79 | Houston | Texas | United States | 77054 | |
| 80 | Houston | Texas | United States | 77074 | |
| 81 | West Jordan | Utah | United States | 84088 | |
| 82 | Richmond | Virginia | United States | 23233 | |
| 83 | Richmond | Virginia | United States | 23294 | |
| 84 | Seattle | Washington | United States | 98105 | |
| 85 | Spokane | Washington | United States | 99207 |
Sponsors and Collaborators
- Bayer
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT00567164
Other Study ID Numbers:
- 91698
- 311642
First Posted:
Dec 4, 2007
Last Update Posted:
Mar 12, 2014
Last Verified:
Jan 1, 2014
Keywords provided by Bayer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The date of first subject, first visit was 22 Oct 2007. The date of last subject, last visit was 11 Nov 2009. |
|---|---|
| Pre-assignment Detail | A total of 2450 subjects were screened ; 563 failed screening. The remaining 1887 subjects were assigned to treatment. Of these, 1864 (98.8%) were in the Full Analysis Set (FAS), ie, study medication was dispensed to them and they had at least 1 post-baseline observation. A total of 1196 (63.4%) subjects completed the study. |
| Arm/Group Title | Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) | Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) |
|---|---|---|---|
| Arm/Group Description | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. | 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected. |
| Period Title: Overall Study | |||
| STARTED | 1421 | 234 | 232 |
| Subjects Received Treatment | 1406 | 232 | 226 |
| COMPLETED | 875 | 161 | 160 |
| NOT COMPLETED | 546 | 73 | 72 |
Baseline Characteristics
| Arm/Group Title | Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) | Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | Total |
|---|---|---|---|---|
| Arm/Group Description | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. | 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected. | Total of all reporting groups |
| Overall Participants | 1406 | 232 | 226 | 1864 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
25.2
(4.5)
|
26.8
(6.8)
|
27.3
(6.4)
|
25.7
(5.2)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
1406
100%
|
232
100%
|
226
100%
|
1864
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Pearl Index |
|---|---|
| Description | The Pearl Index (PI) is the number of pregnancies per 100 woman years. The PI is obtained by dividing the number of pregnancies during treatment (conception date on/after the 1st day of treatment and not later than last day of treatment +14 days) by the treatment exposure time (in 100 women years) that the women were under risk of getting pregnant. The Pearl Index was not calculated individually for either the Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) treatment arm, nor for the Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) treatment arm, because the low sample size in these treatment arms (approximately. 200 subjects per group) did not allow a reliable PI calculation of these groups alone. |
| Time Frame | Up to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set of Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) treatment arm. Pooled Full Analysis Sets of Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) and Regimen no. 2 of EE20/DRSP (BAY86-5300) treatment arms. |
| Arm/Group Title | Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 |
|---|---|---|
| Arm/Group Description | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment | Pooled FAS of Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) (see first arm) and Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300). Regimen no. 2: Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. |
| Measure Participants | 1406 | 1638 |
| Mean (95% Confidence Interval) [Pregnancies per 100 years of exposure] |
1.65
|
1.92
|
| Title | Number of Bleeding Days (Including Spotting Days) |
|---|---|
| Description | Number of days per participant with bleeding or spotting |
| Time Frame | Up to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data. |
| Arm/Group Title | Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) | Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) |
|---|---|---|---|
| Arm/Group Description | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. | 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected. |
| Measure Participants | 1317 | 222 | 207 |
| Mean (Standard Deviation) [Days] |
39.9
(29.6)
|
46.8
(33.1)
|
51.8
(34.6)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300), Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0001 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -11.85 | |
| Confidence Interval |
() 95% -16.3 to -7.394 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 30.356 |
|
| Estimation Comments | ||
| Title | Number of Bleeding Days (Excluding Spotting Days) |
|---|---|
| Description | Number of days per participant with bleeding (excluding spotting days) |
| Time Frame | Up to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data. |
| Arm/Group Title | Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) | Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) |
|---|---|---|---|
| Arm/Group Description | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. | 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected. |
| Measure Participants | 1317 | 222 | 207 |
| Mean (Standard Deviation) [Days] |
19.4
(15.7)
|
21.4
(15.6)
|
32.9
(23.5)
|
| Title | Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 1. |
|---|---|
| Description | Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 1. Reference period 1 (Day 1 to Day 90) was a 90 day period starting with the initial intake of study medication (protocol-specified to occur on first day of menstrual or withdrawal bleeding after screening). Therefore, the first 90-day reference period contains additional bleeding days (associated with the menstrual cycle prior to the start of study medication) when compared to any other reference period. |
| Time Frame | Day 1 to Day 90 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 1. |
| Arm/Group Title | Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) | Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) |
|---|---|---|---|
| Arm/Group Description | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. | 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected. |
| Measure Participants | 1067 | 176 | 169 |
| Including days with spotting |
16.6
(12.2)
|
18.5
(12.9)
|
19.7
(9.8)
|
| Excluding days with spotting |
8.3
(6.9)
|
9.1
(7.2)
|
12.6
(6.5)
|
| Title | Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 2. |
|---|---|
| Description | Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 2. Reference period 2 (Day 91 to Day 180) was a 90-day period that started with the intake of study medication at the beginning of Cycle 4. |
| Time Frame | Day 91 to Day 180 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 2. |
| Arm/Group Title | Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) | Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) |
|---|---|---|---|
| Arm/Group Description | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. | 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected. |
| Measure Participants | 950 | 161 | 145 |
| Including days with spotting |
11.0
(9.7)
|
12.5
(10.5)
|
14.8
(8.0)
|
| Excluding days with spotting |
5.1
(5.2)
|
5.4
(5.5)
|
9.7
(6.3)
|
| Title | Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 3 |
|---|---|
| Description | Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 3. Reference period 3 (Day 181 to Day 270) was a 90-day period that started with the intake of study medication at the beginning of Cycle 7. |
| Time Frame | Day 181 to Day 270 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 3. |
| Arm/Group Title | Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) | Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) |
|---|---|---|---|
| Arm/Group Description | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. | 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected. |
| Measure Participants | 863 | 156 | 131 |
| Including days with spotting |
10.0
(8.7)
|
11.4
(10.8)
|
14.8
(8.0)
|
| Excluding days with spotting |
4.7
(4.8)
|
4.9
(5.0)
|
9.4
(6.5)
|
| Title | Number of Days With Bleeding/ (Including and Excluding Spotting) Within 90-day Reference Period 4 |
|---|---|
| Description | Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 4. Reference period 4 (Day 271 to Day 360) was a 90-day period that started with the intake of study medication at the beginning of Cycle 10. |
| Time Frame | Day 271 to Day 360 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 4. |
| Arm/Group Title | Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) | Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) |
|---|---|---|---|
| Arm/Group Description | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. | 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected. |
| Measure Participants | 808 | 143 | 112 |
| Including days with spotting |
9.0
(9.2)
|
9.5
(10.3)
|
13.6
(7.3)
|
| Excluding days with spotting |
4.2
(4.8)
|
4.0
(4.8)
|
8.4
(5.5)
|
| Title | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 1 |
|---|---|
| Description | A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. |
| Time Frame | Up to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 1. |
| Arm/Group Title | Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) | Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) |
|---|---|---|---|
| Arm/Group Description | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. | 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected. |
| Measure Participants | 1124 | 191 | 187 |
| Number [Percentage of Participants] |
84.2
6%
|
83.8
36.1%
|
66.8
29.6%
|
| Title | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 2 |
|---|---|
| Description | A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. |
| Time Frame | Up to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 2. |
| Arm/Group Title | Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) | Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) |
|---|---|---|---|
| Arm/Group Description | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. | 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected. |
| Measure Participants | 1025 | 176 | 180 |
| Number [Percentage of Participants] |
85.9
6.1%
|
84.7
36.5%
|
86.7
38.4%
|
| Title | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 3 |
|---|---|
| Description | A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. |
| Time Frame | Up to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 3. |
| Arm/Group Title | Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) | Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) |
|---|---|---|---|
| Arm/Group Description | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. | 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected. |
| Measure Participants | 868 | 154 | 182 |
| Number [Percentage of Participants] |
78.6
5.6%
|
79.2
34.1%
|
84.6
37.4%
|
| Title | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 4 |
|---|---|
| Description | A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. |
| Time Frame | Up to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 4. |
| Arm/Group Title | Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) | Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) |
|---|---|---|---|
| Arm/Group Description | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. | 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected. |
| Measure Participants | 601 | 121 | 161 |
| Number [Percentage of Participants] |
73.4
5.2%
|
66.1
28.5%
|
86.3
38.2%
|
| Title | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 5 |
|---|---|
| Description | A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. |
| Time Frame | Up to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 5. |
| Arm/Group Title | Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) | Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) |
|---|---|---|---|
| Arm/Group Description | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. | 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected. |
| Measure Participants | 368 | 71 | 155 |
| Number [Percentage of Participants] |
78.0
5.5%
|
69.0
29.7%
|
85.8
38%
|
| Title | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 6 |
|---|---|
| Description | A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. |
| Time Frame | Up to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 6. |
| Arm/Group Title | Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) | Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) |
|---|---|---|---|
| Arm/Group Description | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. | 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected. |
| Measure Participants | 229 | 43 | 155 |
| Number [Percentage of Participants] |
77.7
5.5%
|
69.8
30.1%
|
85.2
37.7%
|
| Title | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 7 |
|---|---|
| Description | A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. |
| Time Frame | Up to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 7. |
| Arm/Group Title | Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) | Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) |
|---|---|---|---|
| Arm/Group Description | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. | 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected. |
| Measure Participants | 129 | 30 | 144 |
| Number [Percentage of Participants] |
78.3
5.6%
|
70.0
30.2%
|
84.0
37.2%
|
| Title | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 8 |
|---|---|
| Description | A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. |
| Time Frame | Up to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 8. |
| Arm/Group Title | Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) | Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) |
|---|---|---|---|
| Arm/Group Description | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. | 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected. |
| Measure Participants | 78 | 13 | 143 |
| Number [Percentage of Participants] |
82.1
5.8%
|
69.2
29.8%
|
86.7
38.4%
|
| Title | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 9 |
|---|---|
| Description | A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. |
| Time Frame | Up to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 9. |
| Arm/Group Title | Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) | Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) |
|---|---|---|---|
| Arm/Group Description | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. | 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected. |
| Measure Participants | 46 | 10 | 138 |
| Number [Percentage of Participants] |
73.9
5.3%
|
80.0
34.5%
|
85.5
37.8%
|
| Title | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 10 |
|---|---|
| Description | A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. |
| Time Frame | Up to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 10. |
| Arm/Group Title | Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) | Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) |
|---|---|---|---|
| Arm/Group Description | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. | 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected. |
| Measure Participants | 19 | 10 | 130 |
| Number [Percentage of Participants] |
78.9
5.6%
|
70.0
30.2%
|
84.6
37.4%
|
| Title | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 11 |
|---|---|
| Description | A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. |
| Time Frame | Up to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 11. |
| Arm/Group Title | Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) | Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) |
|---|---|---|---|
| Arm/Group Description | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. | 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected. |
| Measure Participants | 9 | 8 | 128 |
| Number [Percentage of Participants] |
55.6
4%
|
62.5
26.9%
|
85.9
38%
|
| Title | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 12 |
|---|---|
| Description | A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. |
| Time Frame | Up to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 12. |
| Arm/Group Title | Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) | Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) |
|---|---|---|---|
| Arm/Group Description | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. | 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected. |
| Measure Participants | 4 | 3 | 117 |
| Number [Percentage of Participants] |
0
0%
|
33.3
14.4%
|
78.6
34.8%
|
| Title | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 13 |
|---|---|
| Description | A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. There were no participants who provided bleeding data for cycle 13 in the Flexible (extended) regimen no.1 of EE20/DRSP (BAY86-5300), although one women did receive 13 cycles of treatment. |
| Time Frame | Up to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 13. |
| Arm/Group Title | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) | Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) |
|---|---|---|
| Arm/Group Description | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. | 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected. |
| Measure Participants | 1 | 73 |
| Number [Percentage of Participants] |
0
0%
|
20.5
8.8%
|
| Title | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 14 |
|---|---|
| Description | A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. There were no participants who received treatment in cycle 14 in the Flexible (extended) regimen no.1 of EE20/DRSP (BAY86-5300). There were no participants who provided bleeding data for cycle 14 in the Flexible (extended) regimen no.2 of EE20/DRSP (BAY86-5300), although one woman did receive 14 cycles of treatment. |
| Time Frame | Up to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 14. |
| Arm/Group Title | Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) |
|---|---|
| Arm/Group Description | 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected. |
| Measure Participants | 11 |
| Number [Percentage of Participants] |
9.1
0.6%
|
| Title | Number of Intracyclic Bleeding Days |
|---|---|
| Description | Intracyclic bleeding was considered any bleeding/spotting that occurred between withdrawal bleedings. |
| Time Frame | Up to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding and tablet intake data sufficient to calculate intracyclic bleeding. |
| Arm/Group Title | Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) | Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) |
|---|---|---|---|
| Arm/Group Description | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. | 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected. |
| Measure Participants | 1222 | 208 | 201 |
| Including spotting only episodes |
8.0
(11.8)
|
14.4
(19.1)
|
7.1
(12.7)
|
| Excluding spotting only episodes |
3.6
(7.9)
|
7.3
(12.8)
|
5.2
(11.4)
|
| Title | Number of Scheduled and Unscheduled Bleeding Days |
|---|---|
| Description | Scheduled bleeding is any bleeding/spotting (bl/sp) that occurs during the tablet free interval through the next 4 days of the subsequent treatment cycle. Unscheduled bleeding is any bl/sp that occurs while taking active hormones, except for bl/sp that occurs during the tablet free interval through day 4 of the subsequent treatment cycle or bl/sp on days 1-7 of treatment cycle 1. |
| Time Frame | Up to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding and tablet intake data sufficient to calculate scheduled/unscheduled bleeding. Analysis was only performed for the flexible and stop-and-go extended regimens. |
| Arm/Group Title | Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) |
|---|---|---|
| Arm/Group Description | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. |
| Measure Participants | 1316 | 222 |
| Scheduled bleeding days |
20.6
(14.1)
|
21.9
(13.9)
|
| Unscheduled bleeding days |
20.0
(20.4)
|
25.3
(27.8)
|
| Title | Length of Cycles |
|---|---|
| Description | Cycle length per cycle. For the flexible and stop and go extended treatment arms, a treatment cycle started with the first day of pill intake after a tablet-free interval and ended with the last day of the subsequent tablet-free interval. A tablet-free interval (treatment withdrawal) was defined as at least 3 consecutive days without tablet intake. For the standard 24+4 treatment arm, a new cycle started each time a new blister pack of medication was started. |
| Time Frame | Up to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (ie, all treated participants). Only cycle data from participants with sufficient data to calculate cycle length are included. |
| Arm/Group Title | Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) | Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) |
|---|---|---|---|
| Arm/Group Description | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. | 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected. |
| Measure Participants | 1317 | 222 | 207 |
| Measure Cycles | 5575 | 1021 | 2082 |
| Mean (Standard Deviation) [Days] |
70.9
(41.3)
|
67.6
(39.1)
|
28.8
(10.8)
|
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) | Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | |||
| Arm/Group Description | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. | 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected. | |||
All Cause Mortality |
||||||
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) | Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) | Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 12/1406 (0.9%) | 6/232 (2.6%) | 2/226 (0.9%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal pain | 0/1406 (0%) | 0 | 1/232 (0.4%) | 1 | 0/226 (0%) | 0 |
| Hepatobiliary disorders | ||||||
| Cholecystitis acute | 1/1406 (0.1%) | 1 | 0/232 (0%) | 0 | 0/226 (0%) | 0 |
| Infections and infestations | ||||||
| Acute tonsillitis | 1/1406 (0.1%) | 1 | 0/232 (0%) | 0 | 0/226 (0%) | 0 |
| Appendicitis | 2/1406 (0.1%) | 2 | 0/232 (0%) | 0 | 0/226 (0%) | 0 |
| Diverticulitis | 0/1406 (0%) | 0 | 1/232 (0.4%) | 1 | 0/226 (0%) | 0 |
| Gastroenteritis | 0/1406 (0%) | 0 | 1/232 (0.4%) | 1 | 0/226 (0%) | 0 |
| Influenza | 1/1406 (0.1%) | 1 | 0/232 (0%) | 0 | 0/226 (0%) | 0 |
| Pneumonia | 1/1406 (0.1%) | 1 | 0/232 (0%) | 0 | 0/226 (0%) | 0 |
| Pyelonephritis | 0/1406 (0%) | 0 | 1/232 (0.4%) | 1 | 0/226 (0%) | 0 |
| Sepsis | 0/1406 (0%) | 0 | 1/232 (0.4%) | 1 | 0/226 (0%) | 0 |
| Urinary tract infection | 0/1406 (0%) | 0 | 1/232 (0.4%) | 1 | 0/226 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| Accident | 0/1406 (0%) | 0 | 0/232 (0%) | 0 | 1/226 (0.4%) | 1 |
| Metabolism and nutrition disorders | ||||||
| Dehydration | 0/1406 (0%) | 0 | 1/232 (0.4%) | 1 | 0/226 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Breast cancer | 1/1406 (0.1%) | 1 | 0/232 (0%) | 0 | 0/226 (0%) | 0 |
| Malignant melanoma | 0/1406 (0%) | 0 | 1/232 (0.4%) | 1 | 0/226 (0%) | 0 |
| Thyroid cancer | 1/1406 (0.1%) | 1 | 0/232 (0%) | 0 | 0/226 (0%) | 0 |
| Pregnancy, puerperium and perinatal conditions | ||||||
| Abortion spontaneous | 2/1406 (0.1%) | 2 | 0/232 (0%) | 0 | 1/226 (0.4%) | 1 |
| Psychiatric disorders | ||||||
| Depression | 1/1406 (0.1%) | 1 | 1/232 (0.4%) | 1 | 0/226 (0%) | 0 |
| Renal and urinary disorders | ||||||
| Renal failure | 1/1406 (0.1%) | 1 | 0/232 (0%) | 0 | 0/226 (0%) | 0 |
| Reproductive system and breast disorders | ||||||
| Pelvic prolapse | 1/1406 (0.1%) | 1 | 0/232 (0%) | 0 | 0/226 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) | Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 330/1406 (23.5%) | 68/232 (29.3%) | 65/226 (28.8%) | |||
| Infections and infestations | ||||||
| Nasopharyngitis | 83/1406 (5.9%) | 95 | 15/232 (6.5%) | 17 | 13/226 (5.8%) | 18 |
| Sinusitis | 88/1406 (6.3%) | 103 | 16/232 (6.9%) | 17 | 6/226 (2.7%) | 6 |
| Upper respiratory tract infection | 93/1406 (6.6%) | 102 | 23/232 (9.9%) | 25 | 27/226 (11.9%) | 31 |
| Reproductive system and breast disorders | ||||||
| Cervical dysplasia | 105/1406 (7.5%) | 112 | 21/232 (9.1%) | 22 | 23/226 (10.2%) | 28 |
Limitations/Caveats
The Flexible (extended) Regimen no. 1 Group was enrolled under slightly different eligibility criteria for age, BMI, and fertility status than the other two treatment groups. This did not affect the results or interpretation of the results.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Publication of subgroup data and single center data shall not be performed until the complete study has been published. All relevant aspects regarding publication will be part of the contract between the sponsor and the investigator/institution.
Results Point of Contact
| Name/Title | Therapeutic Area Head |
|---|---|
| Organization | BAYER |
| Phone | |
| clinical-trials-contact@bayerhealthcare.com |
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT00567164
Other Study ID Numbers:
- 91698
- 311642
First Posted:
Dec 4, 2007
Last Update Posted:
Mar 12, 2014
Last Verified:
Jan 1, 2014