Pharmacokinetic Study of AG200-15 Transdermal Patch to Three Anatomical Sites in Healthy Females
This is a pharmacokinetics and safety study over 3 weekly applications.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||A Pharmacokinetic Study of the Agile TCDS AG200-15 Following Weekly Application to Three Anatomical Sites (Abdomen, Buttock and Upper Torso) in Healthy Female Volunteers|
- Pharmacokinetic profile of LNG and EE [ Time Frame: Sampling will occur at 0 hour, 3, 6, 12, 24, 48, 72, 120, 144, 168 hours and after patch removal at 174, 180, 192, 216, 240 hours. ] [ Designated as safety issue: No ]
Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK results will be reported in pg/mL.
Log-transformed PK parameters (AUCs Cmax and Css) will be analyzed with an analysis of variance (ANOVA) model.
- Patch adhesion [ Time Frame: 168 hour timepoint ] [ Designated as safety issue: No ]Adhesion assessed immediately prior to patch removal
- Safety [ Time Frame: Adverse Events will be collected from first dose through 30 days post-dosing ] [ Designated as safety issue: Yes ]Safety evaluations are based on the number of discontinuations due to Adverse Events, changes in physical and gynecological examination, and treatment-emergent changes in vital signs and body weight.
|Study Start Date:||February 2011|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Subjects will be randomly assigned to one of six treatment (site of application) sequences. Each sequence will include three patch application sites: abdomen, buttock, or upper torso excluding breasts.
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.
Pharmacokinetic study to evaluate the safety and pharmacokinetic profile of AG200-15 following application at three different anatomical sites (abdomen, buttock and upper torso).
|United States, Nebraska|
|Lincoln, Nebraska, United States, 68502|
|United States, New Jersey|
|Neptune, New Jersey, United States, 07753|
|Study Director:||Marie Foegh, MD||Agile Therapeutics|