NCT00914693
Completed
Phase 3
Multicenter, Open-label, Uncontrolled Study to Investigate the Efficacy and Safety of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinyl Estradiol and 2.1 mg Gestodene (Material no. 80876395) in a 21-day Regimen for 13 Cycles in 1650 Healthy Female Subjects
ConditionsContraception
InterventionsEthinylestradiol/Gestodene (BAY86-5016)
Overview
- Phase
- Phase 3
- Intervention
- Ethinylestradiol/Gestodene (BAY86-5016)
- Conditions
- Contraception
- Sponsor
- Bayer
- Enrollment
- 1694
- Primary Endpoint
- Occurrence of pregnancy
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The aim of the present study is to prove efficacy and safety of a new contraceptive patch.
Investigators
Eligibility Criteria
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
Arms & Interventions
Arm 1
Intervention: Ethinylestradiol/Gestodene (BAY86-5016)
Outcomes
Primary Outcomes
Occurrence of pregnancy
Time Frame: 13 treatment cycles each consisting of 28 days and follow-up period of 14 days
Secondary Outcomes
- Bleeding pattern and cycle control(13 treatment cycles each consisting of 28 days)
- Cervical smear(13 treatment cycles each consisting of 28 days)
- Adverse events(13 treatment cycles each consisting of 28 days)
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