FC Patch Low: Metabolism Study

Study Overview
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Brief Summary
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The aim of the present study is to investigate the effects of the transdermal patch on the parameters of hemostasis (blood clotting), lipid (fat), and carbohydrate (sugars) metabolism in healthy women who require contraception.

Official Title
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A Single-Center, Open-Label, Crossover, Randomized Study to Investigate the Impact of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinylestradiol and 2.1 mg Gestodene (Material no. 80876395) in a 21-day Regimen as Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (0.03mg/0.15mg) in a 21-day Regimen on Hemostatic Parameters in 30 Women Aged 18 182 35 Years Over 3 Treatment Cycles in Each Period

Conditions
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Contraception

Intervention / Treatment
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* Drug: Gestodene/EE Patch (BAY86-5016)
* Drug: EE/Levonorgestrel (Microgynon, BAY86-4977)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy woman requesting contraception Normal cervical smear not requiring further follow-up History of regular cyclic menstrual periods Willingness to use non-hormonal contraception during the two wash-out cycles both before the start of treatment and between the two treatment periods Exclusion Criteria: Pregnancy or lactation - Obesity (Body Mass Index [BMI] > 30.0 kg/m2) Any diseases or conditions that can compromise the function of the body systems Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results Any disease or condition that may worsen under hormonal treatment Undiagnosed abnormal genital bleeding Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results

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
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>* 21-day regimen per cycle (1 patch a week for 3 weeks followed by a 7-day patch-free period) for 3 cycles<br>|
| Active Comparator: Arm 2<br> | Drug: EE/Levonorgestrel (Microgynon, BAY86-4977)<br>* 21-day regimen per cycle (1 tablet a day for 3 weeks followed by a 7-day tablet-free period) for 3 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prothrombin fragment 1+2, D-dimer |  | Screening, visit 3-7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procoagulatory parameters |  | Screening, visit 3-7 | 
| Anticoagulatory parameters |  | Screening, visit 3-7 | 
| Thrombin and Fibrin turnover parameters |  | Screening, visit 3-7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention of pregnancy