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

Agile Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AG200-15

Study type: Interventional

Funder types: Industry

Identifiers

NCT01375946

ATI-CL16

Details and patient eligibility

About

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.

Full description

Normal conditions - average daily living activities, Dry Sauna - 10 minutes at 168.8 - 179.6 degrees Fahrenheit, Whirlpool - 10 minutes at 102.2 - 105.8 degrees Fahrenheit, Treadmill - 20 - 30 minutes at 60-80% max heart rate, Cold Water - 5 - 15 minutes at 71.6 degrees Fahrenheit.

There will be three treatment periods. Subjects will be randomly assigned to one of the five conditions for the treatment period. The subject will be exposed daily to the condition assigned while wearing the patch. The study patch will be worn for a 7 day treatment period, followed by a 7 day washout period. The total duration of the study is 6 weeks.

Enrollment: 24 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

AG200-15 location

Experimental group

Description:

The subject will wear AG200-15 for 7 days and be exposed to one of 5 external conditions (normal, treadmill, cold water, whirlpool, dry sauna).

Treatment:

Drug: AG200-15