AG200-15 Transdermal Contraceptive Delivery System (TCDS) of Levonorgestrel and Ethinyl Estradiol
|Healthy||Drug: Ortho-Cyclen (r) Drug: AG200-15 containing LNG and EE||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Study to Evaluate Pharmacokinetic Profile of Agile TCDS AG200-15 and to Compare Exposure to Ethinyl Estradiol to Oral Contraceptive (Orthocyclen®) in Healthy Female Volunteers|
- Comparative evaluation of EE pharmacokinetics between AG200-15 and Ortho-Cyclen® [ Time Frame: 0,6,12,24,48,72,120,144,168 hours post patch; 0.5, 1,1.5,3,6,9,12,16&24 hours post Ortho-Cyclen dosing ]Log-transformed PK parameters (AUCs, Cmax and Css) will be analyzed with an analysis of variance (ANOVA) model.
- Safety of AG200-15 including study discontinuation information, changes in physical and GYN exam findings, changes in vital signs, body weight & lab results & all Adverse Events will be summarized [ Time Frame: Adverse Events will be collected from first dose through 30 days post-dosing ]Safety of AG200-15 over two consecutive cycles of therapy will be evaluated.
|Study Start Date:||August 2009|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Active Comparator: Ortho-Cyclen®
Drug: Ortho-Cyclen (r)
an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen.
Other Name: oral contraceptive
investigational transdermal contraceptive delivery system
Drug: AG200-15 containing LNG and EE
transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE
Other Name: transdermal contraception
This is an open-label study comprised of two parts. Part I is a single-arm, run-in cycle with AG200-15 administered to all subjects as a 21-7 day regimen (three consecutive weeks of patch wear followed by a patch-free week).
Part II employs crossover design with subjects randomly assigned to one of the two treatment sequences. Each sequence will include AG200-15 and oral contraceptive (Ortho-Cyclen®) as described below: Sequence 1: AG200-15 (Period 1) followed by oral contraceptive, Ortho-Cyclen® (Period 2); Sequence 2: Oral contraceptive, Ortho-Cyclen® (Period 1) followed by AG200-15 (Period 2) Both AG200-15 and Ortho-Cyclen® will be administered as 21-7 day regimen (three consecutive weeks of drug-taking followed by a drug-free week). Duration of each treatment Period is 28 days (one cycle of therapy).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01243580
|United States, Florida|
|Miami, Florida, United States, 33169|
|Study Director:||Marie Foegh, MD||Agile Therapeutics|