Pharmacokinetic Study Of AGILE AG200-15 After Weekly Application Under Various Conditions in Healthy Female Volunteers

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

A study to evaluate pharmacokinetic profile, wearability and safety of AG200-15, transdermal delivery of levonorgestrel (LNG) and ethinyl estradiol (EE), under normal conditions and external conditions of heat, humidity, cold water and exercise.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Agile Therapeutics
• Treatments: Contraceptive Agents

Criteria

Inclusion Criteria:

• Healthy women, ages 18-45

• Body mass index (BMI)of ≥18 and less than or equal to 32, and weight ≥ 110 lbs.

• Willing to use a non-hormonal method of contraception if of childbearing potential, or have already undergone previous bilateral tubal ligation or hysterectomy

• Willing to refrain from use of alcohol and grapefruit juice from 48 hours prior to patch application until completion of each treatment period

• Willing to give informed consent to participate in study

Exclusion Criteria:

• Known or suspected pregnancy

• Breast-feeding or within 1 month after stopping breast-feeding

• Smokers

• Any disease that may worsen with hormonal treatment

• Hypersensitivity to transdermal preparations or sensitivity to surgical/medical tape