Trial Condition(s):

Contraception

Transdermal contraceptive patch - endometrial effects study

Bayer Identifier:

14287

ClinicalTrials.gov Identifier:

NCT00896571

EudraCT Number:

2009-010599-45

Study Completed

Trial Purpose

The aim of the present study is to investigate the effects of the transdermal patch on the endometrium in healthy women who require contraception.

Inclusion Criteria
- Requiring contraception
 - Normal cervical smear
 - Smokers not older than 30 years
 - History of regular cyclic menstrual periods
Exclusion Criteria
- Pregnancy or lactation
 - Obesity (BMI> 30 kg/m2)
 - Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
 - Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
 - Use of other contraceptive methods than study medication

Trial Summary

Enrollment Goal
92
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

emovis GmbH

Berlin, Germany, 10629

Status
Completed
 

Trial Design