ContraceptionPhase 1NCT01083264
Relative Bioavailability, Transdermally Administered EE and GSD, 3 Applications Sites
A Phase 1 study testing Gestodene/EE Patch (BAY86-5016) in people with Contraception, run by Bayer at 1 site in Germany.
Trial summary
Influence of different application sites on the blood levels after administration of a fertility control patch Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- 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
- 43 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2009to May 2010
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Healthy female subjects
- Age 18-45 years
- Body mass index (BMI) 18-30kg/m²
- At least 3 months since delivery, abortion, or lactation before the first screening examination
- Ability to understand and follow study-related instructions
- Willingness to accept the synchronizing cycle and to use non-hormonal methods of contraception after starting the synchronizing cycle and during the treatment periods
Who cannot join
- Contra-indications for use of combined (estrogen/progestin) contraceptives (e.g. history of venous/arterial disease, liver disorders, migraine)
- Skin diseases with suspected alteration of dermal resorption and /or increased risk for dermal intolerance
- Regular use of medicines other than contraceptives
- Smokers (at the age of 31 to 45 years)
- Clinically relevant findings (e.g. blood pressure, physical and gynecological examination, laboratory examination)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Randomized, Crossover Study to Investigate the Relative Bioavailability of Transdermally Administered Ethinylestradiol (EE) and Gestodene (GSD) After Repeated Applications of a Fertility Control Patch Containing 0.55 mg Ethinylestradiol and 2.1 mg Gestodene to 3 Different Application Sites (Buttocks, Arm Versus Abdomen) in Healthy Young Female Subjects
Influence of different application sites on the blood levels after administration of a fertility control patch
- Conditions
- Contraception
- Being tested
- Gestodene/EE Patch (BAY86-5016)
- Keywords
- Pharmacokinetics
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
Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: buttocks
Gestodene/EE Patch (BAY86-5016)Drug
Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: arm
Gestodene/EE Patch (BAY86-5016)Drug
Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: abdomen
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Gestodene/EE Patch (BAY86-5016) |
| Arm 2 | Experimental | Not described Receives: Drug: Gestodene/EE Patch (BAY86-5016) |
| Arm 3 | 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.
AUC(0-168) for EE and Gestodene during week 4 of each treatment period
Measured: Week 4 of each treatment period ( 3 periods)
Secondary outcomes (2)
Pharmacokinetic parameters of EE and GSD: Cmax, Cmin, Cav, tmax, t1/2 obtained during week 4, Ctrough obtained at the end of each week
Measured: Week 1-5 of each treatment period
Adverse Events
Measured: Week 1-5 of each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startOct 2009
- Primary completionMay 2010
- Study completionMay 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 43 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
- NCT01083264
- Sponsor's protocol ID
- 91608
- Other IDs
- 2009-011151-52, 2009
- Status last verified
- Jun 2014
- First submitted
- 8 Mar 2010
- Last updated
- 23 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Randomized, Crossover Study to Investigate the Relative Bioavailability of Transdermally Administered Ethinylestradiol (EE) and Gestodene (GSD) After Repeated Applications of a Fertility Control Patch Containing 0.55 mg Ethinylestradiol and 2.1 mg Gestodene to 3 Different Application Sites (Buttocks, Arm Versus Abdomen) in Healthy Young Female Subjects
- ClinicalTrials.gov ID
- NCT01083264
- Acronym / sponsor ID
- 91608
- Conditions
- Contraception
- Keywords
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 9 Mar 2010 (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.
Influence of different application sites on the blood levels after administration of a fertility control patch
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Gestodene/EE Patch (BAY86-5016) |
| Arm 2 | Experimental | Drug: Gestodene/EE Patch (BAY86-5016) |
| Arm 3 | Experimental | Drug: Gestodene/EE Patch (BAY86-5016) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy female subjects
- Age 18-45 years
- Body mass index (BMI) 18-30kg/m²
- At least 3 months since delivery, abortion, or lactation before the first screening examination
- Ability to understand and follow study-related instructions
Key exclusion criteria (5 listed)
- Contra-indications for use of combined (estrogen/progestin) contraceptives (e.g. history of venous/arterial disease, liver disorders, migraine)
- Skin diseases with suspected alteration of dermal resorption and /or increased risk for dermal intolerance
- Regular use of medicines other than contraceptives
- Smokers (at the age of 31 to 45 years)
- Clinically relevant findings (e.g. blood pressure, physical and gynecological examination, laboratory examination)
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)Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: buttocks | Drug | Arm 1 |
| Gestodene/EE Patch (BAY86-5016)Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: arm | Drug | Arm 2 |
| Gestodene/EE Patch (BAY86-5016)Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: abdomen | Drug | Arm 3 |
Primary outcome
AUC(0-168) for EE and Gestodene during week 4 of each treatment period
Time frame: Week 4 of each treatment period ( 3 periods)
2 secondary outcomes
Pharmacokinetic parameters of EE and GSD: Cmax, Cmin, Cav, tmax, t1/2 obtained during week 4, Ctrough obtained at the end of each week
Time frame: Week 1-5 of each treatment period
Adverse Events
Time frame: Week 1-5 of each treatment period
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 23 Jun 2014.
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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 1 study testing Gestodene/EE Patch (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 6 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 23 Jun 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
AUC(0-168) for EE and Gestodene during week 4 of each treatment period (time frame: Week 4 of each treatment period ( 3 periods)). 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 23 Jun 2014.