EU/LA Pearl Index Study - Transdermal Contraceptive Patch

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The aim of the present study is to prove efficacy and safety of a new contraceptive patch.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Contraceptive Agents; Ethinyl Estradiol; Femovan; Gestodene

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