Pharmacokinetic Study of AG200-15 Transdermal Patch to Three Anatomical Sites in Healthy Females
|ClinicalTrials.gov Identifier: NCT01422135|
Recruitment Status : Completed
First Posted : August 23, 2011
Last Update Posted : September 20, 2011
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: AG200-15||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||February 2011|
|Primary Completion Date :||April 2011|
|Study Completion Date :||April 2011|
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 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. ]
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 ]Adhesion assessed immediately prior to patch removal
- Safety [ Time Frame: Adverse Events will be collected from first dose through 30 days post-dosing ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01422135
|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|