Transdermal Contraceptive Delivery System (TCDS), Also Known as AG200-15 Patch Arm

• Status: Completed
• Trial end date: 2011-06-01
• 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; Contraceptives, Oral, Hormonal; Estradiol; Ethinyl Estradiol; Levonorgestrel

Criteria

Inclusion Criteria:

• sexually active women requesting contraception

• Regular menses every 24 - 35 days

• In good general health, confirmed by medical history, physical (including gynecologic examination adn 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