Study Completed

Contraception, Ovulation Inhibition, Contraceptives, Oral

Bayer Identifier:

91698

ClinicalTrials.gov Identifier:

NCT00567164

EudraCT Number:

Not Available

EU CT Number:

Not Available

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.

Key Participants Requirements

Sex

Female

Age

18 - 45 Years

Trial summary

Enrollment Goal

1887

Trial Dates

October 2007 - November 2009

Phase

Phase 3

Could I Receive a placebo

Products

EE20/DRSP (BAY86-5300)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	Comprehensive Clinical Trials	West Palm Beach, 33409, United States
Completed	Rosemark Women Care Specialist	Idaho Falls, 83404, United States
Completed	Women's Health Care Specialist	Paw Paw, 49079, United States
Completed	Volunteer Research Group	Knoxville, 37920, United States
Completed	National Clinical Research, Inc.	Richmond, 23294, United States
Completed	Coastal Carolina Research Center	Mt. Pleasant, 29464, United States
Completed	Seattle Women's: Health, Research, Gynecology	Seattle, 98105, United States
Completed	Affiliated Clinical Research, Inc.	LasVegas, 89106, United States
Completed	Eastern Carolina Women's Center	New Bern, 28562, United States
Completed	South Carolina Clinical Research Center	Columbia, 29201, United States
Completed	Clinical Research of Philadelphia, LLC	Philadelphia, 19114, United States
Completed	University Clinical Research, Inc.	Pembroke Pines, 33024, United States
Completed	Blue Hill Medical Group	Pacific Palisades, 90272, United States
Completed	Lyndhurst Gynecologic Associates	Winston-Salem, 27103, United States
Completed	Rapid Medical Research Inc.	Cleveland, 44122, United States
Completed	Clinical Trials Research Services, LLC	Pittsburgh, 15206, United States
Completed	Mount Vernon Clinical Research	Atlanta, 30328, United States
Completed	Genesis Center for Clinical Research	San Diego, 92103, United States
Completed	New Age Medical Research Corp.	Miami, 33186, United States
Completed	Visions Clinical Research - Tucson	Tucson, 85712, United States
Completed	Hawthorne Medical Research, Inc.	Winston-Salem, 27103, United States
Terminated	Oregon Health and Science University	Portland, 97239, United States
Completed	The Clinical Trial Center, LLC	Jenkintown, 19046, United States
Completed	Phoenix Ob-Gyn Assoicates	Moorestown, 08057, United States
Completed	Medical Center for Clinical Research	San Diego, 92108, United States
Completed	Women's Clinic of Lincoln, PC	Lincoln, 68510, United States
Completed	Research Across America	Dallas, 75234, United States
Terminated	Center for Women's Research	Chicago, 60612, United States
Completed	Adam Patterson OB-GYN	Memphis, 38120, United States
Completed	Clinical Research Center of Nevada	Las Vegas, 89104, United States
Completed	Obstetrical & Gynecological Associates, PA	Houston, 77054, United States
Completed	Advanced Clinical Research	West Jordan, 84088, United States
Completed	York Clinical Consulting	Marrero, 70072, United States
Completed	Columbus Center for Women's Health Research	Columbus, 43213, United States
Completed	Woman’s Clinical Research	Newburgh, 47630, United States
Completed	Phoenix Internal Medicine Associates	Waterbury, 06708, United States
Terminated	Odyssey Research Services	Bismarck, 58501, United States
Completed	Montgomery Women's Health Associates	Montgomery, 36116, United States
Completed	Central Kentucky Research Associates, Inc.	Lexington, 40509, United States
Completed	Miami Research Associates	South Miami, 33143, United States
Completed	North Spokane Women's Clinic	Spokane, 99207, United States
Completed	AGMG Clinical Research	Anaheim, 92801-2811, United States
Completed	Lynn Health Science Institute	Oklahoma City, 73112, United States
Completed	Solano Clinical Research	Vallejo, 94589, United States
Completed	Downtown Women's Healthcare	Denver, 80218, United States
Completed	Women's Health Practice	Champaign, 61820, United States
Completed	Women's Medical Research Group, LLC	Clearwater, 33759, United States
Completed	Advanced Research Associates	Corpus Christi, 78414, United States
Completed	Estrella Womens Health Center	Phoenix, 85031, United States
Completed	Clinical Research of South Floirda	Coral Gables, 33134, United States
Terminated	Clinical Trial Center of Colorado	Greenwood Village, 80111, United States
Completed	East Valley Family Physicians, PLC	Chandler, 85224, United States
Completed	Mesa Family Medical Center	Mesa, 85203, United States
Completed	Advanced Clinical Research	Boise, 83704, United States
Completed	Jackson Clinic	Jackson, 38305-3618, United States
Completed	Chattanooga Medical Research, LLC	Chattanooga, 37404, United States
Completed	Visions Clinical Research	Boynton Beach, 33472-2952, United States
Completed	Lynn Institute of the Rockies	Colorado Springs, 80909, United States
Completed	Soapstone Center for Clinical Research	Decatur, 30034, United States
Completed	Bayview Research Group, LLC	Beverly Hills, 90212, United States
Completed	Clinical Trial Network	Houston, 77074, United States
Terminated	NN	Plantation, 33313, United States
Completed	Segal Institute for Clinical Research	North Miami, 33161, United States
Completed	Rochester Clinical Research	Rochester, 14618, United States
Completed	Fiel Family & Sports Medicine, PC	Tempe, 85283, United States
Completed	Altus Research	Lake Worth, 33461, United States
Completed	Meridien Research	St. Petersburg, 33709, United States
Completed	Affiliated Clinical Research, Inc.	Las Vegas, 89109, United States
Completed	Texas FamiliCare Clinical Research	Colleyville, 76034, United States
Completed	PPS Clinical Research, LLC	Chesterfield, 63017, United States
Completed	St. John's Center for Clinical Research	Jacksonville, 32259, United States
Completed	Nature Coast Clinical Research	Crystal River, 34429, United States
Completed	Chase Medical Research, LLC	Waterbury, 06708, United States
Completed	Virginia Women's Center	Richmond, 23233, United States
Completed	Clinical Research Associates, Inc.	Nashville, 37203, United States
Terminated	NN	Plantation, 33313, United States
Completed	University of Medicine & Dentistry of New Jersey	New Brunswick, 08901, United States
Completed	Center for Pharmaceutical Research	Kansas City, 64114, United States
Completed	Meridien Research	Brooksville, 34613, United States
Completed	Oregon Health and Science University	Portland, 97239-3011, United States
Completed	Heartland Research Associates, LLC	Wichita, 67207, United States
Completed	Genova Clinical Research, Inc.	Tucson, 85741, United States
Completed	Carolina Women's Research & Wellness Center	Durham, 27713, United States
Completed	Odyssey Research Services	Bismarck, 58501, United States
Completed	APEX Research Institute	Santa Ana, 92705, United States
Completed	Pinon Family Practice, PC	Littleton, 80123, United States
Completed	Desert Clinical Research	Mesa, 85213, United States
Completed	Hawthorne Medical Research, Inc.	Winston-Salem, 27103, United States
Completed	Anchor Research Center	Naples, 34102, United States
Completed	Research Associates	Boise, 83702, United States

Primary Outcome

Pearl Index
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
Safety Issue:
No

Secondary Outcome

Number of bleeding days (including spotting days)
Number of days per participant with bleeding or spotting
Time Frame:
Up to 1 year
Safety Issue:
No
Number of bleeding days (excluding spotting days)
Number of days per participant with bleeding (excluding spotting days)
Time Frame:
Up to 1 year
Safety Issue:
No
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.
Time Frame:
Day 1 to Day 90
Safety Issue:
No
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.
Time Frame:
Day 91 to Day 180
Safety Issue:
No
Number of days with bleeding (including and excluding spotting) within 90-day reference period 3
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
Safety Issue:
No
Number of days with bleeding/ (including and excluding spotting) within 90-day reference period 4
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
Safety Issue:
No
Percentage of participants with a withdrawal bleeding episode for cycle 1
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
Safety Issue:
No
Percentage of participants with a withdrawal bleeding episode for cycle 2
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
Safety Issue:
No
Percentage of participants with a withdrawal bleeding episode for cycle 3
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
Safety Issue:
No
Percentage of participants with a withdrawal bleeding episode for cycle 4
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
Safety Issue:
No
Percentage of participants with a withdrawal bleeding episode for cycle 5
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
Safety Issue:
No
Percentage of participants with a withdrawal bleeding episode for cycle 6
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
Safety Issue:
No
Percentage of participants with a withdrawal bleeding episode for cycle 7
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
Safety Issue:
No
Percentage of participants with a withdrawal bleeding episode for cycle 8
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
Safety Issue:
No
Percentage of participants with a withdrawal bleeding episode for cycle 9
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
Safety Issue:
No
Percentage of participants with a withdrawal bleeding episode for cycle 10
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
Safety Issue:
No
Percentage of participants with a withdrawal bleeding episode for cycle 11
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
Safety Issue:
No
Percentage of participants with a withdrawal bleeding episode for cycle 12
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
Safety Issue:
No
Percentage of participants with a withdrawal bleeding episode for cycle 13
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
Safety Issue:
No
Percentage of participants with a withdrawal bleeding episode for cycle 14
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
Safety Issue:
No
Number of intracyclic bleeding days
Intracyclic bleeding was considered any bleeding/spotting that occurred between withdrawal bleedings.
Time Frame:
Up to 1 year
Safety Issue:
No
Number of scheduled and unscheduled bleeding days
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
Safety Issue:
No
Length of cycles
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
Safety Issue:
No

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

Additional Information

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