ContraceptionPhase 3NCT00910637
Study Investigating the Efficacy and Safety of a Contraceptive Patch for 13 Cycles
A Phase 3 study testing Gestodene/EE Patch (BAY86-5016) in people with Contraception, run by Bayer at 63 sites in United States.
Trial summary
This study is examining a birth control patch for 13 cycles (1 year). 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
- What is being tested?
- Gestodene/EE Patch (BAY86-5016)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,502 participants
- Where
- 63 sitesUnited States
- Study dates
- 1 May 2009to 13 Dec 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Requiring contraception
- Normal cervical smear
- Maximum age for smokers is 35
- History of regular cyclic menstrual periods
Who cannot join
- Pregnancy or lactation
- Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
- Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
- Use of other contraceptive methods than study medication
Trial locations and contacts
63 sites in 1 country.
63 sites in 1 country
United States63 sites
Study site
Albuquerque, New Mexico, 87102
Study site
Atlanta, Georgia, 30328
Study site
Birmingham, Alabama, 35235
Research Associates
Boise, Idaho, 83702
Study site
Boston, Massachusetts, 02118
Visions Clinical Research
Boynton Beach, Florida, 33472-2952
Study site
Carmichael, California, 95608
Study site
Chaska, Minnesota, 55318
Study site
Chattanooga, Tennessee, 37404
Study site
Chicago, Illinois, 60612
Study site
Cincinnati, Ohio, 45267-0457
Study site
Cleveland, Ohio, 44122
Study site
Columbia, South Carolina, 29201
Study site
Columbus, Ohio, 43213
Study site
Corpus Christi, Texas, 78414
Practice Research Organization
Dallas, Texas, 75230
Study site
Decatur, Georgia, 30034
Study site
Denver, Colorado, 80218
Study site
Eugene, Oregon, 97401
Study site
Glendale, Arizona, 85304
Advances in Health, inc.
Houston, Texas, 77030
The Woman's Hospital of Texas
Houston, Texas, 77054
Rosemark Women Care Specialist
Idaho Falls, Idaho, 83404
Study site
Jacksonville, Florida, 32207
Study site
Knoxville, Tennessee, 37920
Study site
Las Vegas, Nevada, 89030
Study site
Las Vegas, Nevada, 89106
Office of Dr. R. Garn Mabey, MD
Las Vegas, Nevada, 89128
Study site
Lawrenceville, New Jersey, 08648
Study site
Lincoln, Nebraska, 68510
Study site
Littleton, Colorado, 80122
Study site
Marrero, Louisiana, 70072
Women's Care Center, PLC
Memphis, Tennessee, 38119
Study site
Miami, Florida, 33186
Study site
Moorestown, New Jersey, 08057
Study site
Mt. Pleasant, South Carolina, 29464
Study site
Nashville, Tennessee, 37203
Study site
Nashville, Tennessee, 37205
Study site
New Bern, North Carolina, 28562
Study site
New London, Connecticut, 06320
Study site
New York, New York, 10032
Study site
Newburgh, Indiana, 47630
Study site
Norfolk, Virginia, 23507
York Clinical Consulting
Oklahoma City, Oklahoma, 73120
Study site
Pacific Palisades, California, 90272
Study site
Paramount, California, 90723
Study site
Pembroke Pines, Florida, 33024
Study site
Philadelphia, Pennsylvania, 19114
Precision Trials
Phoenix, Arizona, 85032
Study site
Pittsburgh, Pennsylvania, 15213
Study site
Portland, Oregon, 97239-3011
Study site
Roswell, Georgia, 30075
Genesis Center for Clinical Research
San Diego, California, 92103
Study site
San Diego, California, 92108
Study site
San Diego, California, 92123
Study site
Santa Ana, California, 92705
Women's Clinical Research Center
Seattle, Washington, 98105
Study site
South Bend, Indiana, 46601
Meridien Research
St. Petersburg, Florida, 33709
Study site
Torrance, California, 90502
Visions Clinical Research - Tucson
Tucson, Arizona, 85712
Study site
Warwick, Rhode Island, 02886
Study site
Winston-Salem, North Carolina, 27103
About this study
Official title: Multicenter, Open-label, Uncontrolled Study to Investigate the Efficacy and Safety of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinyl Estradiol and 2.1 mg Gestodene in a 21-day Regimen for 13 Cycles in 1650 Healthy Female Subjects
This study is examining a birth control patch for 13 cycles (1 year).
- Conditions
- Contraception
- Being tested
- Gestodene/EE Patch (BAY86-5016)
- Keywords
- Pregnancy prevention, Female contraception, Patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gestodene/EE Patch (BAY86-5016)Drug
55 mg ethinyl estradiol \& 2.1 mg gestodene, 21 days for 13 cycles
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Gestodene/EE Patch (BAY86-5016) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of pregnancy (yes/no) while on treatment
Measured: 13 treatment cycles each consisting of 28 days and follow-up period of 14 days
Secondary outcomes (4)
Vital signs
Measured: 13 treatment cycles each consisting of 28 days
Physical and gynecological examinations
Measured: 13 treatment cycles each consisting of 28 days
Laboratory assessments
Measured: 13 treatment cycles each consisting of 28 days
Adverse events (AE monitoring)
Measured: 13 treatment cycles each consisting of 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study start1 May 2009
- Primary completion13 Dec 2010
- Study completion13 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,502 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
- NCT00910637
- Sponsor's protocol ID
- 91555
- Other IDs
- 310802
- Status last verified
- Apr 2021
- First submitted
- 29 May 2009
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-label, Uncontrolled Study to Investigate the Efficacy and Safety of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinyl Estradiol and 2.1 mg Gestodene in a 21-day Regimen for 13 Cycles in 1650 Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT00910637
- Acronym / sponsor ID
- 91555
- Conditions
- Contraception
- Keywords
- Pregnancy prevention, Female contraception, Patch
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,502 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 1 May 2009 (actual)
- Primary completion
- 13 Dec 2010 (actual)
- Study completion
- 13 Dec 2010 (actual)
- First posted
- 1 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is examining a birth control patch for 13 cycles (1 year).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Gestodene/EE Patch (BAY86-5016) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Requiring contraception
- Normal cervical smear
- Maximum age for smokers is 35
- History of regular cyclic menstrual periods
Key exclusion criteria (4 listed)
- Pregnancy or lactation
- Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
- Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
- Use of other contraceptive methods than study medication
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 |
|---|---|---|
| Gestodene/EE Patch (BAY86-5016)55 mg ethinyl estradiol \& 2.1 mg gestodene, 21 days for 13 cycles | Drug | Arm 1 |
Primary outcome
Occurrence of pregnancy (yes/no) while on treatment
Time frame: 13 treatment cycles each consisting of 28 days and follow-up period of 14 days
4 secondary outcomes
Vital signs
Time frame: 13 treatment cycles each consisting of 28 days
Physical and gynecological examinations
Time frame: 13 treatment cycles each consisting of 28 days
Laboratory assessments
Time frame: 13 treatment cycles each consisting of 28 days
Adverse events (AE monitoring)
Time frame: 13 treatment cycles each consisting of 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
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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
63 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 Gestodene/EE Patch (BAY86-5016) in people with Contraception, run by Bayer at 63 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 4 inclusion and 4 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 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of pregnancy (yes/no) while on treatment (time frame: 13 treatment cycles each consisting of 28 days and follow-up period of 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2021.