Trial Condition(s):
Contraception, Ovulation inhibition, Contraceptives, Oral
Efficacy and safety of two flexible extended regimens of BAY86-5300 (SH T00186D) in comparison with the conventional regimen of YAZ
Trial Purpose
The purpose of this study is to determine whether the study drug is safe and effective.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | ||
|---|---|---|---|
Locations Comprehensive Clinical Trials West Palm Beach, United States, 33409 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Rosemark Women Care Specialist Idaho Falls, United States, 83404 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Women's Health Care Specialist Paw Paw, United States, 49079 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Volunteer Research Group Knoxville, United States, 37920 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations National Clinical Research, Inc. Richmond, United States, 23294 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Coastal Carolina Research Center Mt. Pleasant, United States, 29464 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Seattle Women's: Health, Research, Gynecology Seattle, United States, 98105 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Affiliated Clinical Research, Inc. LasVegas, United States, 89106 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Eastern Carolina Women's Center New Bern, United States, 28562 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations South Carolina Clinical Research Center Columbia, United States, 29201 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Clinical Research of Philadelphia, LLC Philadelphia, United States, 19114 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations University Clinical Research, Inc. Pembroke Pines, United States, 33024 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Blue Hill Medical Group Pacific Palisades, United States, 90272 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Lyndhurst Gynecologic Associates Winston-Salem, United States, 27103 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Rapid Medical Research Inc. Cleveland, United States, 44122 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Clinical Trials Research Services, LLC Pittsburgh, United States, 15206 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Mount Vernon Clinical Research Atlanta, United States, 30328 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Genesis Center for Clinical Research San Diego, United States, 92103 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations New Age Medical Research Corp. Miami, United States, 33186 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Visions Clinical Research - Tucson Tucson, United States, 85712 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Hawthorne Medical Research, Inc. Winston-Salem, United States, 27103 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Oregon Health and Science University Portland, United States, 97239 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations The Clinical Trial Center, LLC Jenkintown, United States, 19046 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Phoenix Ob-Gyn Assoicates Moorestown, United States, 08057 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Medical Center for Clinical Research San Diego, United States, 92108 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Women's Clinic of Lincoln, PC Lincoln, United States, 68510 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Research Across America Dallas, United States, 75234 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Center for Women's Research Chicago, United States, 60612 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Adam Patterson OB-GYN Memphis, United States, 38120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Clinical Research Center of Nevada Las Vegas, United States, 89104 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Obstetrical & Gynecological Associates, PA Houston, United States, 77054 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Advanced Clinical Research West Jordan, United States, 84088 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations York Clinical Consulting Marrero, United States, 70072 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Columbus Center for Women's Health Research Columbus, United States, 43213 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Woman’s Clinical Research Newburgh, United States, 47630 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Phoenix Internal Medicine Associates Waterbury, United States, 06708 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Odyssey Research Services Bismarck, United States, 58501 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Montgomery Women's Health Associates Montgomery, United States, 36116 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Central Kentucky Research Associates, Inc. Lexington, United States, 40509 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Miami Research Associates South Miami, United States, 33143 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations North Spokane Women's Clinic Spokane, United States, 99207 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations AGMG Clinical Research Anaheim, United States, 92801-2811 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Lynn Health Science Institute Oklahoma City, United States, 73112 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Solano Clinical Research Vallejo, United States, 94589 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Downtown Women's Healthcare Denver, United States, 80218 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Women's Health Practice Champaign, United States, 61820 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Women's Medical Research Group, LLC Clearwater, United States, 33759 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Advanced Research Associates Corpus Christi, United States, 78414 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Estrella Womens Health Center Phoenix, United States, 85031 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Clinical Research of South Floirda Coral Gables, United States, 33134 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Clinical Trial Center of Colorado Greenwood Village, United States, 80111 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations East Valley Family Physicians, PLC Chandler, United States, 85224 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Mesa Family Medical Center Mesa, United States, 85203 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Advanced Clinical Research Boise, United States, 83704 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Jackson Clinic Jackson, United States, 38305-3618 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Chattanooga Medical Research, LLC Chattanooga, United States, 37404 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Visions Clinical Research Boynton Beach, United States, 33472-2952 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Lynn Institute of the Rockies Colorado Springs, United States, 80909 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Soapstone Center for Clinical Research Decatur, United States, 30034 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Bayview Research Group, LLC Beverly Hills, United States, 90212 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Clinical Trial Network Houston, United States, 77074 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations NN Plantation, United States, 33313 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Segal Institute for Clinical Research North Miami, United States, 33161 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Rochester Clinical Research Rochester, United States, 14618 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Fiel Family & Sports Medicine, PC Tempe, United States, 85283 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Altus Research Lake Worth, United States, 33461 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Meridien Research St. Petersburg, United States, 33709 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Affiliated Clinical Research, Inc. Las Vegas, United States, 89109 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Texas FamiliCare Clinical Research Colleyville, United States, 76034 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations PPS Clinical Research, LLC Chesterfield, United States, 63017 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations St. John's Center for Clinical Research Jacksonville, United States, 32259 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Nature Coast Clinical Research Crystal River, United States, 34429 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Chase Medical Research, LLC Waterbury, United States, 06708 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Virginia Women's Center Richmond, United States, 23233 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Clinical Research Associates, Inc. Nashville, United States, 37203 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations University of Medicine & Dentistry of New Jersey New Brunswick, United States, 08901 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Center for Pharmaceutical Research Kansas City, United States, 64114 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Meridien Research Brooksville, United States, 34613 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Oregon Health and Science University Portland, United States, 97239-3011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Heartland Research Associates, LLC Wichita, United States, 67207 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Genova Clinical Research, Inc. Tucson, United States, 85741 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Carolina Women's Research & Wellness Center Durham, United States, 27713 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Odyssey Research Services Bismarck, United States, 58501 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations APEX Research Institute Santa Ana, United States, 92705 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Pinon Family Practice, PC Littleton, United States, 80123 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Desert Clinical Research Mesa, United States, 85213 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Anchor Research Center Naples, United States, 34102 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Research Associates Boise, United States, 83702 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Pearl IndexThe 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.Timeframe: Up to 1 year
Secondary Outcome
- Number of bleeding days (including spotting days)Number of days per participant with bleeding or spottingTimeframe: Up to 1 year
- Number of bleeding days (excluding spotting days)Number of days per participant with bleeding (excluding spotting days)Timeframe: Up to 1 year
- Number of days with bleeding (including and excluding spotting) within 90-day reference period 1.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.Timeframe: Day 1 to Day 90
- Number of days with bleeding (including and excluding spotting) within 90-day reference period 2.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.Timeframe: Day 91 to Day 180
- Number of days with bleeding (including and excluding spotting) within 90-day reference period 3Number 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.Timeframe: Day 181 to Day 270
- Number of days with bleeding/ (including and excluding spotting) within 90-day reference period 4Number 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.Timeframe: Day 271 to Day 360
- Percentage of participants with a withdrawal bleeding episode for cycle 1A 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.Timeframe: Up to 1 year
- Percentage of participants with a withdrawal bleeding episode for cycle 2A 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.Timeframe: Up to 1 year
- Percentage of participants with a withdrawal bleeding episode for cycle 3A 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.Timeframe: Up to 1 year
- Percentage of participants with a withdrawal bleeding episode for cycle 4A 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.Timeframe: Up to 1 year
- Percentage of participants with a withdrawal bleeding episode for cycle 5A 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.Timeframe: Up to 1 year
- Percentage of participants with a withdrawal bleeding episode for cycle 6A 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.Timeframe: Up to 1 year
- Percentage of participants with a withdrawal bleeding episode for cycle 7A 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.Timeframe: Up to 1 year
- Percentage of participants with a withdrawal bleeding episode for cycle 8A 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.Timeframe: Up to 1 year
- Percentage of participants with a withdrawal bleeding episode for cycle 9A 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.Timeframe: Up to 1 year
- Percentage of participants with a withdrawal bleeding episode for cycle 10A 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.Timeframe: Up to 1 year
- Percentage of participants with a withdrawal bleeding episode for cycle 11A 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.Timeframe: Up to 1 year
- Percentage of participants with a withdrawal bleeding episode for cycle 12A 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.Timeframe: Up to 1 year
- Percentage of participants with a withdrawal bleeding episode for cycle 13A 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.Timeframe: Up to 1 year
- Percentage of participants with a withdrawal bleeding episode for cycle 14A 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.Timeframe: Up to 1 year
- Number of intracyclic bleeding daysIntracyclic bleeding was considered any bleeding/spotting that occurred between withdrawal bleedings.Timeframe: Up to 1 year
- Number of scheduled and unscheduled bleeding daysScheduled 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.Timeframe: Up to 1 year
- Length of cyclesCycle 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.Timeframe: Up to 1 year
Additional Information
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