ContraceptionPhase 3NCT00567164
Efficacy and Safety of Two Flexible Extended Regimens of BAY86-5300 (SH T00186D) in Comparison With the Conventional Regimen of YAZ
A Phase 3 study testing EE20/DRSP (BAY86-5300) and EE20/DRSP (YAZ, BAY86-5300) in people with Contraception and Ovulation Inhibition, run by Bayer at 85 sites in United States.
Trial summary
The purpose of this study is to determine whether the study drug is safe and effective. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Ovulation Inhibition, Contraceptives, Oral
- What is being tested?
- EE20/DRSP (BAY86-5300) and EE20/DRSP (YAZ, BAY86-5300)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,887 participants
- Where
- 85 sitesUnited States
- Study dates
- Oct 2007to Nov 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women between 18 and 45 requesting oral contraception. Smokers may not exceed 35 years of age.
Who cannot join
- The use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study.
Trial locations and contacts
85 sites in 1 country.
85 sites in 1 country
United States85 sites
Study site
Anaheim, California, 92801-2811
Study site
Atlanta, Georgia, 30328
Study site
Beverly Hills, California, 90212
Study site
Bismarck, North Dakota, 58501
Study site
Boise, Idaho, 83702
Study site
Boise, Idaho, 83704
Study site
Boynton Beach, Florida, 33472-2952
Study site
Brooksville, Florida, 34613
Study site
Champaign, Illinois, 61820
Study site
Chandler, Arizona, 85224
Study site
Chattanooga, Tennessee, 37404
Study site
Chesterfield, Missouri, 63017
Study site
Chicago, Illinois, 60612
Study site
Clearwater, Florida, 33759
Study site
Cleveland, Ohio, 44122
Study site
Colleyville, Texas, 76034
Study site
Colorado Springs, Colorado, 80909
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Columbia, South Carolina, 29201
Study site
Columbus, Ohio, 43213
Study site
Coral Gables, Florida, 33134
Study site
Corpus Christi, Texas, 78414
Study site
Crystal River, Florida, 34429
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Dallas, Texas, 75234
Study site
Decatur, Georgia, 30034
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Denver, Colorado, 80218
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Durham, North Carolina, 27713
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Greenwood Village, Colorado, 80111
Study site
Houston, Texas, 77054
Study site
Houston, Texas, 77074
Study site
Idaho Falls, Idaho, 83404
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Jackson, Tennessee, 38305-3618
Study site
Jacksonville, Florida, 32259
Study site
Jenkintown, Pennsylvania, 19046
Study site
Kansas City, Missouri, 64114
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Knoxville, Tennessee, 37920
Study site
Lake Worth, Florida, 33461
Study site
Las Vegas, Nevada, 89104
Study site
Las Vegas, Nevada, 89109
Study site
LasVegas, Nevada, 89106
Study site
Lexington, Kentucky, 40509
Study site
Lincoln, Nebraska, 68510
Study site
Littleton, Colorado, 80123
Study site
Marrero, Louisiana, 70072
Study site
Memphis, Tennessee, 38120
Study site
Mesa, Arizona, 85203
Study site
Mesa, Arizona, 85213
Study site
Miami, Florida, 33186
Study site
Montgomery, Alabama, 36116
Study site
Moorestown, New Jersey, 08057
Study site
Mt. Pleasant, South Carolina, 29464
Study site
Naples, Florida, 34102
Study site
Nashville, Tennessee, 37203
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New Bern, North Carolina, 28562
Study site
New Brunswick, New Jersey, 08901
Study site
Newburgh, Indiana, 47630
Study site
North Miami, Florida, 33161
Study site
Oklahoma City, Oklahoma, 73112
Study site
Pacific Palisades, California, 90272
Study site
Paw Paw, Michigan, 49079
Study site
Pembroke Pines, Florida, 33024
Study site
Philadelphia, Pennsylvania, 19114
Study site
Phoenix, Arizona, 85031
Study site
Pittsburgh, Pennsylvania, 15206
Study site
Plantation, Florida, 33313
Study site
Portland, Oregon, 97239-3011
Study site
Portland, Oregon, 97239
Study site
Richmond, Virginia, 23233
Study site
Richmond, Virginia, 23294
Study site
Rochester, New York, 14618
Study site
San Diego, California, 92103
Study site
San Diego, California, 92108
Study site
Santa Ana, California, 92705
Study site
Seattle, Washington, 98105
Study site
South Miami, Florida, 33143
Study site
Spokane, Washington, 99207
Study site
St. Petersburg, Florida, 33709
Study site
Tempe, Arizona, 85283
Study site
Tucson, Arizona, 85712
Study site
Tucson, Arizona, 85741
Study site
Vallejo, California, 94589
Study site
Waterbury, Connecticut, 06708
Study site
West Jordan, Utah, 84088
Study site
West Palm Beach, Florida, 33409
Study site
Wichita, Kansas, 67207
Study site
Winston-Salem, North Carolina, 27103
About this study
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
The purpose of this study is to determine whether the study drug is safe and effective.
Read the 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.
- Conditions
- Contraception, Ovulation Inhibition, Contraceptives, Oral
- Being tested
- EE20/DRSP (BAY86-5300), EE20/DRSP (YAZ, BAY86-5300)
- Keywords
- Oral Contraception, Birth Control pill, Healthy women requesting oral contraception, Contraceptive efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EE20/DRSP (BAY86-5300)Drug
Also called SH T00186D
Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone
EE20/DRSP (BAY86-5300)Drug
Also called SH T00186D
Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone
EE20/DRSP (YAZ, BAY86-5300)Drug
Also called SH T00186D
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)
| Study group | Role | What they receive |
|---|---|---|
| Flexible (extended) regimen no. 1 of EE20/DRSP (BAY86-5300) | Experimental | 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 Receives: Drug: EE20/DRSP (BAY86-5300) |
| Flexible (extended) regimen no. 2 of EE20/DRSP (BAY86-5300) | Experimental | 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. Receives: Drug: EE20/DRSP (BAY86-5300) |
| Conventional regimen of EE20/DRSP (YAZ, BAY86-5300) | Active comparator | 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. Receives: Drug: EE20/DRSP (YAZ, BAY86-5300) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year
Secondary outcomes (23)
Number of Bleeding Days (Including Spotting Days)
Number of days per participant with bleeding or spotting
Measured: Up to 1 year
Number of Bleeding Days (Excluding Spotting Days)
Number of days per participant with bleeding (excluding spotting days)
Measured: 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.
Measured: 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.
Measured: Day 91 to Day 180
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.
Measured: Day 181 to Day 270
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.
Measured: Day 271 to Day 360
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.
Measured: Up to 1 year
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.
Measured: Up to 1 year
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.
Measured: Up to 1 year
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.
Measured: Up to 1 year
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.
Measured: Up to 1 year
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.
Measured: Up to 1 year
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.
Measured: Up to 1 year
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.
Measured: Up to 1 year
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.
Measured: Up to 1 year
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.
Measured: Up to 1 year
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.
Measured: Up to 1 year
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.
Measured: Up to 1 year
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.
Measured: Up to 1 year
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.
Measured: Up to 1 year
Number of Intracyclic Bleeding Days
Intracyclic bleeding was considered any bleeding/spotting that occurred between withdrawal bleedings.
Measured: Up to 1 year
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.
Measured: Up to 1 year
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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2007 (estimated)
- Study startOct 2007
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,887 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567164
- Sponsor's protocol ID
- 91698
- Other IDs
- 311642
- Status last verified
- Jan 2014
- First submitted
- 3 Dec 2007
- Last updated
- 12 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Jensen JT, Garie SG, Trummer D, Elliesen J. Bleeding profile of a flexible extended regimen of ethinylestradiol/drospirenone in US women: an open-label, three-arm, active-controlled, multicenter study. Contraception. 2012 Aug;86(2):110-8. doi: 10.1016/j.contraception.2011.12.009. Epub 2012 Jan 26.
PubMed 22281416
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00567164
- Acronym / sponsor ID
- 91698
- Conditions
- Contraception, Ovulation Inhibition, Contraceptives, Oral
- Keywords
- Oral Contraception, Birth Control pill, Healthy women requesting oral contraception, Contraceptive efficacy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,887 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 4 Dec 2007 (estimated)
- Results
- Posted 12 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the study drug is safe and effective.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Flexible (extended) regimen no. 1 of EE20/DRSP (BAY86-5300) | Experimental | Drug: 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 |
| Flexible (extended) regimen no. 2 of EE20/DRSP (BAY86-5300) | Experimental | Drug: 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. |
| Conventional regimen of EE20/DRSP (YAZ, BAY86-5300) | Active comparator | Drug: 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy women between 18 and 45 requesting oral contraception. Smokers may not exceed 35 years of age.
Key exclusion criteria (1 listed)
- The use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EE20/DRSP (BAY86-5300)Also: SH T00186DCombination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone | Drug | Flexible (extended) regimen no. 1 of EE20/DRSP (BAY86-5300) |
| EE20/DRSP (BAY86-5300)Also: SH T00186DCombination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone | Drug | Flexible (extended) regimen no. 2 of EE20/DRSP (BAY86-5300) |
| EE20/DRSP (YAZ, BAY86-5300)Also: SH T00186DFixed 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) | Drug | Conventional regimen of EE20/DRSP (YAZ, BAY86-5300) |
Primary outcome
Pearl Index
Time frame: 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.
23 secondary outcomes
Number of Bleeding Days (Including Spotting Days)
Time frame: Up to 1 year
Number of Bleeding Days (Excluding Spotting Days)
Time frame: Up to 1 year
Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 1.
Time frame: Day 1 to Day 90
Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 2.
Time frame: Day 91 to Day 180
Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 3
Time frame: Day 181 to Day 270
Number of Days With Bleeding/ (Including and Excluding Spotting) Within 90-day Reference Period 4
Time frame: Day 271 to Day 360
Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 1
Time frame: Up to 1 year
Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 2
Time frame: Up to 1 year
Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 3
Time frame: Up to 1 year
Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 4
Time frame: Up to 1 year
Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 5
Time frame: Up to 1 year
Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 6
Time frame: Up to 1 year
Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 7
Time frame: Up to 1 year
Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 8
Time frame: Up to 1 year
Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 9
Time frame: Up to 1 year
Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 10
Time frame: Up to 1 year
Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 11
Time frame: Up to 1 year
Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 12
Time frame: Up to 1 year
Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 13
Time frame: Up to 1 year
Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 14
Time frame: Up to 1 year
Number of Intracyclic Bleeding Days
Time frame: Up to 1 year
Number of Scheduled and Unscheduled Bleeding Days
Time frame: Up to 1 year
Length of Cycles
Time frame: Up to 1 year
Results and safety
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Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22281416Jensen JT, Garie SG, Trummer D, Elliesen J. Bleeding profile of a flexible extended regimen of ethinylestradiol/drospirenone in US women: an open-label, three-arm, active-controlled, multicenter study. Contraception. 2012 Aug;86(2):110-8. doi: 10.1016/j.contraception.2011.12.009. Epub 2012 Jan 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
85 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EE20/DRSP (BAY86-5300) and EE20/DRSP (YAZ, BAY86-5300) in people with Contraception and Ovulation Inhibition, run by Bayer at 85 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 85 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pearl Index (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00567164, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2014.