FC Patch Low: Metabolism Study

Phase 2

Completed

• Conditions: Contraception
• Interventions: Drug: EE/Levonorgestrel (Microgynon, BAY86-4977); Drug: Gestodene/EE Patch (BAY86-5016)

• Registration Number: NCT00933179
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-03
• Study First Submitted QC: 2009-07-03
• Study First Posted: 2009-07-07
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-13
• Last Update Posted: 2014-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 2	EE/Levonorgestrel (Microgynon, BAY86-4977)	-
Arm 1	Gestodene/EE Patch (BAY86-5016)	-

Primary Outcome Measures

Name	Time	Method
Prothrombin fragment 1+2, D-dimer	Screening, visit 3-7

Secondary Outcome Measures

Name	Time	Method
Thrombin and Fibrin turnover parameters	Screening, visit 3-7
Procoagulatory parameters	Screening, visit 3-7
Anticoagulatory parameters	Screening, visit 3-7