Inhibition of Ovulation and Pharmacokinetics of Transdermal Ethinylestradiol (EE) and Gestodene (GSD)

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Contraception, Ovulation Inhibition

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Ethinylestradiol/Gestodene (BAY86-5016)<br>* 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)<br>|
| Experimental: Arm 2<br> | Drug: Ethinylestradiol/Gestodene (BAY86-5016)<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3 |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3 |  | 4 months | 
| Course of gonadotropins (FSH, LH, P, E2) |  | 4 months | 
| Endometrial thickness and Follicle size |  | 4 months | 
| Pharmacokinetics of Ethinylestradiol (EE), Gestodene (GSD) and SHBG in treatment cycles 2 and 3 |  | 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 |  | 4 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Female contraception, Ovulation inhibition