Trial Condition(s):

Contraception

FC Patch low: Metabolism Study

Bayer Identifier:

91557

ClinicalTrials.gov Identifier:

NCT00933179

EudraCT Number:

2008-007024-26

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
30
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Gestodene/EE Patch (BAY86-5016)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Dinox GmbH Berlin

Berlin, Germany, 10115

Status
Completed
 

Trial Design