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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01375946

Run by

Agile Therapeutics

People needed

24

Starts

2011-05-01

Expected to finish

2011-06-01

Last updated by the study team

2018-07-31

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Pharmacology of Miami, Inc. — Miami, Florida, United States

Full record on ClinicalTrials.gov

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