Russia/Ukraine Suppression of Ovarian Activity Study

Study Overview
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Brief Summary
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The purpose of this study is to look into the effectiveness of a new investigational medication applied as a transdermal patch. The patch is applied on the skin with study medication that is absorbed through the skin suppressing ovarian activity and therefore preventing an egg from leaving an ovary (ovulation). The study will look into the study drug's safety and how well it is tolerated and its absorption, breakdown and elimination in the body. It describes how the body affects a specific drug after administration.

Official Title
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Multicenter, Open-label, Uncontrolled Study to Investigate Suppression of Ovarian Activity of a Transdermal Contraceptive Patch Containing 0.55 mg Ethinyl Estradiol and 2.1 mg Gestodene in 80 Young Female Volunteers Over 3 Treatment Cycles

Conditions
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Contraception

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy female subjects requesting contraception Aged 18 to 35 years (inclusive); smokers must not be older than 30 years Normal or clinically insignificant cervical smear not requiring further follow-up History of regular cyclic menstrual periods Willingness to use nonhormonal methods of contraception during the entire study Proven ovulation upon completion of the pretreatment cycle Exclusion Criteria: Pregnancy or lactation Obesity (body mass index [BMI] > 30.0 kg/m2) Significant skin reaction to transdermal preparations or sensitivity to surgical/medical tape Any disease or condition that may worsen under hormonal treatment Use of hormonal contraception other than study medication during the study

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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gestodene/EE Patch<br> | Drug: Gestodene/EE Patch (BAY86-5016)<br>* 7 day patch containing 0.55 mg ethinyl estradiol and 2.1 gestodene in a 21 day regimen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suppression of ovulatory activity proved by progesterone and estradiol concentrations | Estradiol levels > 100pmol/L indicate some ovarian activity and progesterone levels > 5nmol/L in subjects with estradiol levels > 100pmol/L reflect ovulation or luteinized unruptured follicles. | Treatment day 29 to day 84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentration, AUC (area under curve) of Gestodene |  | Multiple time points up to treatment day 84 | 
| Serum concentration, AUC (area under curve) of ethinyl estradiol |  | Multiple time points up to treatment day 84 | 
| Serum concentration, AUC (area under curve) of Sexual hormone binding globulin |  | Multiple time points up to treatment day 84 | 
| Number of patients with adverse events |  | Up to 84 days | 
| Number of patients with abnormal safety laboratory |  | Up to 84 days | 
| Time course of follicle-stimulating hormone | Serum concentration of follicle-stimulating hormone (FSH) | Day 27 of pretreatment cycle to treatment day 83 | 
| Time course of luteinizing hormone | Serum concentration of luteinizing hormone (LH) | Day 27 of pretreatment cycle to treatment day 83 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contraception, Transdermal contraceptive patch, Safety, Efficacy, Pharmacokinetic