ContraceptionPhase 2NCT00873483
US Ovulation Inhibition Study in Obese Women
A Phase 2 study testing Ethinylestradiol/Gestodene (BAY86-5016) in people with Contraception, run by Bayer at 6 sites in United States.
Trial summary
Birth Control Patch Study Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Ethinylestradiol/Gestodene (BAY86-5016)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 6 sitesUnited States
- Study dates
- 30 Apr 2009to 3 Mar 2010
- Phase
- Phase 2
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female subject requesting contraception
- Age: 18 - 35 years (inclusive); smokers must not be older than 30 years at the time of informed consent
- Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months)
- History of regular cyclic menstrual periods
- Willingness to use non-hormonal methods of contraception during the entire study.
Who cannot join
- Pregnancy or lactation (less than 3 menstrual cycles since delivery, abortion, or lactation before start of treatment)
- Hypersensitivity to any ingredient of the study drug
- Significant skin reaction to transdermal preparations or sensitivity to surgical/medical tape
- Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug (e.g., known skin disease with suspected alteration of dermal absorption or poor adherence of the patch such as psoriasis)
- Any disease or condition that may worsen under hormonal treatment.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Houston, Texas, 77054
Study site
Philadelphia, Pennsylvania, 19114
Study site
San Diego, California, 92108
Study site
Sandy Springs, Georgia, 30328
Study site
Seattle, Washington, 98105
Study site
Tucson, Arizona, 85712
About this study
Official title: Multicenter, Open-Label, Uncontrolled Study to Investigate the Impact of Weight and BMI on Inhibition of Ovulation of a Transdermal Patch Formulation Containing 0.55 mg Ethinylestradiol and 2.1 mg Gestodene in Young Female Volunteers Stratified by BMI Over a Period of 3 Treatment Cycles
Birth Control Patch Study
- Conditions
- Contraception
- Being tested
- Ethinylestradiol/Gestodene (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.
Ethinylestradiol/Gestodene (BAY86-5016)Drug
0.55 mg ethinyl estradiol \& 2.1 mg gestodene, 21 days for 3 cycles
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Ethinylestradiol/Gestodene (BAY86-5016) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Hoogland Scores
Measured: Treatment Cycles 2 & 3
Secondary outcomes (3)
Laboratory values for E2, progesterone, FSH and LH
Measured: Pretreatment & regularly during Treatment Cycles 1, 2, 3
Endometrial thickness
Measured: Pretreatment & regularly during Treatment Cycles 1, 2, 3
Follicle size
Measured: Pretreatment & regularly during Treatment Cycles 1, 2, 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2009 (estimated)
- Study start30 Apr 2009
- Primary completion3 Mar 2010
- Study completion3 Mar 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 173 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
- NCT00873483
- Sponsor's protocol ID
- 13871
- Status last verified
- Apr 2021
- First submitted
- 31 Mar 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 Impact of Weight and BMI on Inhibition of Ovulation of a Transdermal Patch Formulation Containing 0.55 mg Ethinylestradiol and 2.1 mg Gestodene in Young Female Volunteers Stratified by BMI Over a Period of 3 Treatment Cycles
- ClinicalTrials.gov ID
- NCT00873483
- Acronym / sponsor ID
- 13871
- Conditions
- Contraception
- Keywords
- Pregnancy prevention, female contraception, patch
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2009 (actual)
- Primary completion
- 3 Mar 2010 (actual)
- Study completion
- 3 Mar 2010 (actual)
- First posted
- 1 Apr 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.
Birth Control Patch Study
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: Ethinylestradiol/Gestodene (BAY86-5016) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female subject requesting contraception
- Age: 18 - 35 years (inclusive); smokers must not be older than 30 years at the time of informed consent
- Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months)
- History of regular cyclic menstrual periods
- Willingness to use non-hormonal methods of contraception during the entire study.
Key exclusion criteria (5 listed)
- Pregnancy or lactation (less than 3 menstrual cycles since delivery, abortion, or lactation before start of treatment)
- Hypersensitivity to any ingredient of the study drug
- Significant skin reaction to transdermal preparations or sensitivity to surgical/medical tape
- Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug (e.g., known skin disease with suspected alteration of dermal absorption or poor adherence of the patch such as psoriasis)
- Any disease or condition that may worsen under hormonal treatment.
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 |
|---|---|---|
| Ethinylestradiol/Gestodene (BAY86-5016)0.55 mg ethinyl estradiol \& 2.1 mg gestodene, 21 days for 3 cycles | Drug | Arm 1 |
Primary outcome
Determination of Hoogland Scores
Time frame: Treatment Cycles 2 & 3
3 secondary outcomes
Laboratory values for E2, progesterone, FSH and LH
Time frame: Pretreatment & regularly during Treatment Cycles 1, 2, 3
Endometrial thickness
Time frame: Pretreatment & regularly during Treatment Cycles 1, 2, 3
Follicle size
Time frame: Pretreatment & regularly during Treatment Cycles 1, 2, 3
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
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ethinylestradiol/Gestodene (BAY86-5016) in people with Contraception, run by Bayer at 6 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 5 inclusion and 5 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 6 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Determination of Hoogland Scores (time frame: Treatment Cycles 2 & 3). 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.