Pharmacokinetic Study of AG200-15 Transdermal Patch to Three Anatomical Sites in Healthy Females
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|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|
|Actual Primary Completion Date :||April 2011|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|