Pharmacokinetic Study Of AGILE AG200-15 After Weekly Application Under Various Conditions in Healthy Female Volunteers
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.
|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|
- 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
- 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.
|Study Start Date:||May 2011|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Subjects will be randomized to one of six sequences, over three periods.
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.
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.
|United States, Florida|
|Clinical Pharmacology of Miami, Inc.|
|Miami, Florida, United States, 33014|
|Principal Investigator:||Kenneth C Lasseter, MD||Clinical Pharmacology of Miami, Inc.|