ContraceptionPhase 2NCT00915915
Inhibition of Ovulation and Pharmacokinetics of Transdermal Ethinylestradiol (EE) and Gestodene (GSD)
A Phase 2 study testing Ethinylestradiol/Gestodene (BAY86-5016) in people with Contraception and Ovulation Inhibition, run by Bayer at 2 sites in Germany.
Trial summary
Investigation of two transdermal hormone patch formulations for contraception regarding inhibition of ovulation over a period of 3 treatment cycles in healthy young female volunteers 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, Ovulation Inhibition
- What is being tested?
- Ethinylestradiol/Gestodene (BAY86-5016)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesGermany
- Study dates
- Jun 2009to Apr 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
- BMI: 18 BMI 30 kg/m²
- Healthy female volunteers
- Age 18-35 years (smoker not older than 30 years, inclusive)
- Ovulatory pre-treatment cycle, at least 3 month since delivery
- Abortion or lactation before the first screening examination
- Willingness to use non-hormonal methods of contraception during entire study
Who cannot join
- Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous/artial thromboembolic disease
- Regular intake of medication other than OCs
- Clinically relevant findings (blood pressure, physical and gynaecological examination, laboratory examination) anovulatory pre-treatment cycle
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Study site
Berlin, State of Berlin, 10115
Study site
Berlin, State of Berlin, 13353
About this study
Official title: Multicenter, Open-label, Randomized Study to Evaluate Inhibition of Ovulation of Two Transdermal Patch Formulations Containing 0.55 mg Ethinylestradiol and Either 1.05 or 2.1 mg Gestodene in Healthy Young Female Volunteers Over a Period of 3 Treatment Cycles
Investigation of two transdermal hormone patch formulations for contraception regarding inhibition of ovulation over a period of 3 treatment cycles in healthy young female volunteers
- Conditions
- Contraception, Ovulation Inhibition
- Being tested
- Ethinylestradiol/Gestodene (BAY86-5016)
- Keywords
- Female contraception, Ovulation inhibition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethinylestradiol/Gestodene (BAY86-5016)Drug
Transdermal patch: 0.55mg Ethinylestradiol (EE+2.1mg GSD)Gestodene; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles), 1 Follow - up cycle)
Ethinylestradiol/Gestodene (BAY86-5016)Drug
Transdermal patch: 0.55mg Ethinylestradiol (EE+1.05mg GSD)Gestodene; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles), 1 Follow - up cycle)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Ethinylestradiol/Gestodene (BAY86-5016) |
| Arm 2 | 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.
The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3
Measured: 4 months
Secondary outcomes (5)
The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3
Measured: 4 months
Course of gonadotropins (FSH, LH, P, E2)
Measured: 4 months
Endometrial thickness and Follicle size
Measured: 4 months
Pharmacokinetics of Ethinylestradiol (EE), Gestodene (GSD) and SHBG in treatment cycles 2 and 3
Measured: 4 Months
Cervical effects (Insler Score) for determination of hormonal effects on the cervix and the cervical mucus during pre-treatment cycle and treatment cycle 3
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionApr 2010
- Study completionApr 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 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
- NCT00915915
- Sponsor's protocol ID
- 14348
- Other IDs
- 2009-009177-10, 2009
- Status last verified
- Oct 2014
- First submitted
- 18 May 2009
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-label, Randomized Study to Evaluate Inhibition of Ovulation of Two Transdermal Patch Formulations Containing 0.55 mg Ethinylestradiol and Either 1.05 or 2.1 mg Gestodene in Healthy Young Female Volunteers Over a Period of 3 Treatment Cycles
- ClinicalTrials.gov ID
- NCT00915915
- Acronym / sponsor ID
- 14348
- Conditions
- Contraception, Ovulation Inhibition
- Keywords
- Female contraception, Ovulation inhibition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 8 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.
Investigation of two transdermal hormone patch formulations for contraception regarding inhibition of ovulation over a period of 3 treatment cycles in healthy young female volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Ethinylestradiol/Gestodene (BAY86-5016) |
| Arm 2 | 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 (6 listed)
- BMI: 18 BMI 30 kg/m²
- Healthy female volunteers
- Age 18-35 years (smoker not older than 30 years, inclusive)
- Ovulatory pre-treatment cycle, at least 3 month since delivery
- Abortion or lactation before the first screening examination
Key exclusion criteria (3 listed)
- Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous/artial thromboembolic disease
- Regular intake of medication other than OCs
- Clinically relevant findings (blood pressure, physical and gynaecological examination, laboratory examination) anovulatory pre-treatment cycle
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)Transdermal patch: 0.55mg Ethinylestradiol (EE+2.1mg GSD)Gestodene; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles), 1 Follow - up cycle) | Drug | Arm 1 |
| Ethinylestradiol/Gestodene (BAY86-5016)Transdermal patch: 0.55mg Ethinylestradiol (EE+1.05mg GSD)Gestodene; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles), 1 Follow - up cycle) | Drug | Arm 2 |
Primary outcome
The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3
Time frame: 4 months
5 secondary outcomes
The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3
Time frame: 4 months
Course of gonadotropins (FSH, LH, P, E2)
Time frame: 4 months
Endometrial thickness and Follicle size
Time frame: 4 months
Pharmacokinetics of Ethinylestradiol (EE), Gestodene (GSD) and SHBG in treatment cycles 2 and 3
Time frame: 4 Months
Cervical effects (Insler Score) for determination of hormonal effects on the cervix and the cervical mucus during pre-treatment cycle and treatment cycle 3
Time frame: 4 Months
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 28 Oct 2014.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink 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
2 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 and Ovulation Inhibition, run by Bayer at 2 sites 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 6 inclusion and 3 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 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3 (time frame: 4 months). 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 28 Oct 2014.