Trial Condition(s):
Contraception
Transdermal contraceptive patch - endometrial effects study
Bayer Identifier:
14287
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations emovis GmbH Berlin, Germany, 10629 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Single-center,open-label, uncontrolled study to investigate the effects of the transdermal contraceptive patch containing 0.55 mg ethinylestradiol and 2.1 mg gestodene on the endometrium in a 21-day regimen for 13 cycles in 80 healthy women
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Effect on the endometrium at cycle 13Timeframe: 13 treatment cycles (each consisting of 28 days)
Secondary Outcome
- Cervical smearTimeframe: 13 treatment cycles (each consisting of 28 days)
- Adverse eventsTimeframe: 13 treatment cycles (each consisting of 28 days)
- Cycle controlTimeframe: 13 treatment cycles (each consisting of 28 days)
- Safety laboratoryTimeframe: 13 treatment cycles (each consisting of 28 days)
- Occurence of pregnancyTimeframe: 13 treatment cycles (each consisting of 28 days)
Additional Information
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