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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Agile Therapeutics
ClinicalTrials.gov Identifier:
NCT01375946
First received: June 13, 2011
Last updated: September 16, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: AG200-15
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Pharmacokinetic And Wearability Study of the Agile TCDS AG200-15 Following Weekly Application Under Various External Conditions in Healthy Female Volunteers

Further study details as provided by Agile Therapeutics:

Primary Outcome Measures:
  • Pharmacokinetic (PK) profile of LNG and EE. PK results will be reported in pg/mL. [ Time Frame: Pharmacokinetic sampling will be done after exposure to each external condition at 0 hour, 6, 12, 24, 28 72, 120, 144 and 168 hours. ] [ Designated as safety issue: No ]
    Total weekly EE exposure (estimated by the AUC 0-168) EE steady state concentration level, Css calculated as average concentration within 48 h - 168h time interval


Secondary Outcome Measures:
  • Patch adhesion [ Time Frame: 168 hour timepoint ] [ Designated as safety issue: No ]
    Adhesion assessed immediately prior to patch removal

  • Safety [ Time Frame: Duration of study (up to 6 weeks) ] [ Designated as safety issue: Yes ]
    Safety evaluations are based on the number of discontinuations due to Adverse Events, changes from screening to last assessment in physical and gynecological examinations, vital signs, and clinical laboratory tests.


Enrollment: 24
Study Start Date: May 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AG200-15
Subjects will be randomized to one of six sequences, over three periods.
Drug: AG200-15
A transdermal contraceptive delivery system for LNG and EE. A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01375946

Locations
United States, Florida
Clinical Pharmacology of Miami, Inc.
Miami, Florida, United States, 33014
Sponsors and Collaborators
Agile Therapeutics
Investigators
Principal Investigator: Kenneth C Lasseter, MD Clinical Pharmacology of Miami, Inc.
  More Information

No publications provided

Responsible Party: Agile Therapeutics
ClinicalTrials.gov Identifier: NCT01375946     History of Changes
Other Study ID Numbers: ATI-CL16
Study First Received: June 13, 2011
Last Updated: September 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Agile Therapeutics:
Pharmacokinetic Profile (PK) and Safety
PK analysis of EE and LNG

ClinicalTrials.gov processed this record on April 17, 2014