Relative Bioavailability, Transdermally Administered EE and GSD, 3 Applications Sites

Study Overview
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Brief Summary
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Influence of different application sites on the blood levels after administration of a fertility control patch

Official Title
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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

Conditions
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Contraception

Intervention / Treatment
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* Drug: Gestodene/EE Patch (BAY86-5016)
* Drug: Gestodene/EE Patch (BAY86-5016)
* Drug: Gestodene/EE Patch (BAY86-5016)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Gestodene/EE Patch (BAY86-5016)<br>* Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: buttocks<br>|
| Experimental: Arm 2<br> | Drug: Gestodene/EE Patch (BAY86-5016)<br>* Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: arm<br>|
| Experimental: Arm 3<br> | Drug: Gestodene/EE Patch (BAY86-5016)<br>* Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: abdomen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC(0-168) for EE and Gestodene during week 4 of each treatment period |  | Week 4 of each treatment period ( 3 periods) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters of EE and GSD: Cmax, Cmin, Cav, tmax, t1/2 obtained during week 4, Ctrough obtained at the end of each week |  | Week 1-5 of each treatment period | 
| Adverse Events |  | Week 1-5 of each treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics