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

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: AG200-15

Registration Number: NCT01375946

Lead Sponsor: Agile Therapeutics

Brief 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 24

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AG200-15 location	AG200-15	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).

Primary Outcome Measures

Name	Time	Method
AUC(0-168) Profile of Ethinyl Estradiol (EE)	6 weeks	AUC(0-168) profile of EE for external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.
Steady-state Concentration (Css) (48-168) Profile of LNG	6 weeks	Css (48-168) profile of LNG for external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.
Css (48-168) Profile of EE	6 weeks	Css (48-168) profile of EE for external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.
Area Under the Concentration Versus Time Curve (AUC) (0-168) Profile of Levonorgestrel (LNG)	6 weeks	AUC(0-168) profile of LNG for each external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.

Secondary Outcome Measures

Name	Time	Method
Patch Adhesion	6 weeks	Patch adhesion scores by investigator evaluation by external condition; including dry sauna, whirlpool, treadmill exercise, normal, and cold water conditions; using the following scale: 0: \>90% adhered (essentially no lift off of the skin) 1. \>75% adhered but \<90% (some edges showing lift) 2. \>50% adhered but \<75% (half of system lifts off) 3. \<50% (\> half of system lifts off, but undetached) 4. patch completely detached Patches were assessed prior to patch removal.