ContraceptionPhase 2NCT00896571
Transdermal Contraceptive Patch - Endometrial Effects Study
A Phase 2 study testing Ethinylestradiol/Gestogene (BAY86-5016) in people with Contraception, run by Bayer at 1 site in Germany.
Trial summary
The aim of the present study is to investigate the effects of the transdermal patch on the endometrium in healthy women who require contraception. 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/Gestogene (BAY86-5016)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2009to Aug 2011
- 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
- Requiring contraception
- Normal cervical smear
- Smokers not older than 30 years
- History of regular cyclic menstrual periods
Who cannot join
- Pregnancy or lactation
- Obesity (BMI> 30 kg/m2)
- 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
1 site in 1 country.
About this study
Official title: Single-center,Open-label, Uncontrolled Study to Investigate the Effects of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinylestradiol and 2.1 mg Gestodene on the Endometrium in a 21-day Regimen for 13 Cycles in 80 Healthy Women
The aim of the present study is to investigate the effects of the transdermal patch on the endometrium in healthy women who require contraception.
- Conditions
- Contraception
- Being tested
- Ethinylestradiol/Gestogene (BAY86-5016)
- Keywords
- Fertility control, Contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethinylestradiol/Gestogene (BAY86-5016)Drug
7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Ethinylestradiol/Gestogene (BAY86-5016) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on the endometrium at cycle 13
Measured: 13 treatment cycles (each consisting of 28 days)
Secondary outcomes (5)
Cervical smear
Measured: 13 treatment cycles (each consisting of 28 days)
Adverse events
Measured: 13 treatment cycles (each consisting of 28 days)
Cycle control
Measured: 13 treatment cycles (each consisting of 28 days)
Safety laboratory
Measured: 13 treatment cycles (each consisting of 28 days)
Occurence of pregnancy
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 posted11 May 2009 (estimated)
- Study startJul 2009
- Primary completionMay 2011
- Study completionAug 2011
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
- 92 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
- NCT00896571
- Sponsor's protocol ID
- 14287
- Other IDs
- 2009-010599-45, 2009
- Status last verified
- Nov 2014
- First submitted
- 8 May 2009
- Last updated
- 26 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center,Open-label, Uncontrolled Study to Investigate the Effects of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinylestradiol and 2.1 mg Gestodene on the Endometrium in a 21-day Regimen for 13 Cycles in 80 Healthy Women
- ClinicalTrials.gov ID
- NCT00896571
- Acronym / sponsor ID
- 14287
- Conditions
- Contraception
- Keywords
- Fertility control, Contraception
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 11 May 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.
The aim of the present study is to investigate the effects of the transdermal patch on the endometrium in healthy women who require contraception.
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/Gestogene (BAY86-5016) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Requiring contraception
- Normal cervical smear
- Smokers not older than 30 years
- History of regular cyclic menstrual periods
Key exclusion criteria (5 listed)
- Pregnancy or lactation
- Obesity (BMI> 30 kg/m2)
- 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 |
|---|---|---|
| Ethinylestradiol/Gestogene (BAY86-5016)7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen | Drug | Arm 1 |
Primary outcome
Effect on the endometrium at cycle 13
Time frame: 13 treatment cycles (each consisting of 28 days)
5 secondary outcomes
Cervical smear
Time frame: 13 treatment cycles (each consisting of 28 days)
Adverse events
Time frame: 13 treatment cycles (each consisting of 28 days)
Cycle control
Time frame: 13 treatment cycles (each consisting of 28 days)
Safety laboratory
Time frame: 13 treatment cycles (each consisting of 28 days)
Occurence of pregnancy
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 26 Nov 2014.
- Click here and search for EMA websynopsis resultLink provided by the sponsor.
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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
1 site 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/Gestogene (BAY86-5016) in people with Contraception, run by Bayer at 1 site in Germany.
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 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 26 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Effect on the endometrium at cycle 13 (time frame: 13 treatment cycles (each consisting of 28 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 26 Nov 2014.