Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Agile Therapeutics
• Treatments: Contraceptive Agents; Contraceptives, Oral; Estradiol; Ethinyl Estradiol

Criteria

Inclusion Criteria:

Healthy females

• 17(in states where the legal age of consent to receive contraceptives is 17)-40 years

• Regular, consistent menstrual cycles between 25 and 35 days

• Sexually active women requesting birth control

• In good general health, confirmed by medical history, physical (including gynecologic) examination and screening laboratory values

Exclusion Criteria:

• Known or suspected pregnancy;

• Lactating women

• 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