Transdermal Contraceptive Patch - Endometrial Effects Study
Phase 2
Completed
- Conditions
- Contraception
- Interventions
- Drug: Ethinylestradiol/Gestogene (BAY86-5016)
- Registration Number
- NCT00896571
- Lead Sponsor
- Bayer
- Brief Summary
The aim of the present study is to investigate the effects of the transdermal patch on the endometrium in healthy women who require contraception.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 92
Inclusion Criteria
- Requiring contraception
- Normal cervical smear
- Smokers not older than 30 years
- History of regular cyclic menstrual periods
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Ethinylestradiol/Gestogene (BAY86-5016) -
- Primary Outcome Measures
Name Time Method Effect on the endometrium at cycle 13 13 treatment cycles (each consisting of 28 days)
- Secondary Outcome Measures
Name Time Method Cervical smear 13 treatment cycles (each consisting of 28 days) Adverse events 13 treatment cycles (each consisting of 28 days) Cycle control 13 treatment cycles (each consisting of 28 days) Safety laboratory 13 treatment cycles (each consisting of 28 days) Occurence of pregnancy 13 treatment cycles (each consisting of 28 days)