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AG200-15 Transdermal Contraceptive Delivery System (TCDS) of Levonorgestrel and Ethinyl Estradiol

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ClinicalTrials.gov Identifier: NCT01243580
Recruitment Status : Completed
First Posted : November 18, 2010
Results First Posted : December 19, 2017
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Agile Therapeutics

November 16, 2010
November 18, 2010
July 21, 2017
December 19, 2017
January 23, 2018
August 2009
December 2009   (Final data collection date for primary outcome measure)
  • Comparative Evaluation of Ethinyl Estradiol (EE) Cmax Between AG200-15 and Ortho-Cyclen® in Week 1 [ Time Frame: 3 months ]
    Comparative evaluation of ethinyl estradiol (EE) Cmax between AG200-15 and Ortho-Cyclen® in week 1 for cycle 2 and 3.
  • Comparative Evaluation of EE Cmax Between AG200-15 and Ortho-Cyclen® in Week 3 [ Time Frame: 3 months ]
    Comparative evaluation of EE Cmax between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3.
  • Comparative Evaluation of EE AUC(0-168hrs Post-first Dose) Between AG200-15 and Ortho-Cyclen® in Week 1 [ Time Frame: 3 months ]
    Comparative evaluation of EE AUC (0-168hrs post-first dose) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3.
  • Comparative Evaluation of EE AUC (0-168hrs Post-first Dose) Between AG200-15 and Ortho-Cyclen® in Week 3 [ Time Frame: 3 months ]
    Comparative evaluation of EE AUC (0-168hrs post-first dose) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3.
  • Comparative Evaluation of EE Css (1) Between AG200-15 and Ortho-Cyclen® in Week 1 [ Time Frame: 3 months ]
    Comparative evaluation of EE Css (1) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15 the average concentration within the 48-168 h time-interval was measured.
  • Comparative Evaluation of EE Css (1) Between AG200-15 and Ortho-Cyclen® in Week 3 [ Time Frame: 3 months ]
    Comparative evaluation of EE Css (1) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15 the average concentration within the 48-168 h time-interval was measured.
  • Comparative Evaluation of EE Css (2) Between AG200-15 and Ortho-Cyclen® in Week 1 [ Time Frame: 3 months ]
    Comparative evaluation of EE Css (2) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For Ag200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 48-168h time interval (AUC/time interval).
  • Comparative Evaluation of EE Css (2) Between AG200-15 and Ortho-Cyclen® in Week 3 [ Time Frame: 3 months ]
    Comparative evaluation of EE Css (2) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For Ag200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 48-168h time interval (AUC/time interval).
  • Comparative Evaluation of EE Css (3) Between AG200-15 and Ortho-Cyclen® in Week 1 [ Time Frame: 3 months ]
    Comparative evaluation of EE Css (3) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 0-168h time interval (AUC/time interval).
  • Comparative Evaluation of EE Css (3) Between AG200-15 and Ortho-Cyclen® in Week 3 [ Time Frame: 3 months ]
    Comparative evaluation of EE Css (3) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 0-168h time interval (AUC/time interval).
  • Evaluation of LNG Cmax Between AG200-15 in Week 1 and 3 [ Time Frame: 3 months ]
    Evaluation of LNG Cmax Between AG200-15 in Week 1 and 3 for cycles 2 and 3.
  • Evaluation of LNG AUC (0-168hrs Post-first Dose) Between AG200-15 in Week 1 and 3 [ Time Frame: 3 months ]
    Evaluation of LNG AUC (0-168hrs post-first dose) Between AG200-15 in Week 1 and 3 for cycles 2 and 3.
  • Evaluation of LNG Css (1) Between AG200-15 in Week 1 and 3 [ Time Frame: 3 months ]
    Comparative evaluation of EE Css (1) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen, steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For Ag200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 48-168h time interval (AUC/time interval).
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.
Complete list of historical versions of study NCT01243580 on ClinicalTrials.gov Archive Site
Not Provided
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.
Not Provided
Not Provided
 
AG200-15 Transdermal Contraceptive Delivery System (TCDS) of Levonorgestrel and Ethinyl Estradiol
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
Pharmacokinetics and safety of AG200-15 over two consecutive cycles of therapy will be evaluated.

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).

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy
  • Drug: Ortho-Cyclen
    Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen.
    Other Name: oral contraceptive
  • Drug: AG200-15
    AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE
    Other Name: transdermal contraception
  • Active Comparator: Ortho-Cyclen®
    Ortho-Cyclen® is a comparator drug intervention
    Intervention: Drug: Ortho-Cyclen
  • Experimental: AG200-15
    AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention
    Intervention: Drug: AG200-15
Archer DF, Stanczyk FZ, Rubin A, Foegh M. Ethinyl estradiol and levonorgestrel pharmacokinetics with a low-dose transdermal contraceptive delivery system, AG200-15: a randomized controlled trial. Contraception. 2012 Jun;85(6):595-601. doi: 10.1016/j.contraception.2011.10.006. Epub 2011 Nov 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
Same as current
December 2009
December 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy women, ages 18-45
  • Body mass index (BMI) ≥18 and ≤32, and weight ≥ 110 lbs.
  • Willing to use a non-hormonal method of contraception if at risk of pregnancy, OR have already undergone previous bilateral tubal ligation or hysterectomy
  • Willing to refrain from use of alcohol and grapefruit juice from 48 hours prior until completion of each treatment period

Exclusion Criteria:

  • Known or suspected pregnancy;
  • Lactating women
  • Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
  • Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
  • Use of other contraceptive methods than study medication
  • Smokers
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01243580
ATI-CL14
No
Not Provided
Not Provided
Agile Therapeutics
Agile Therapeutics
Not Provided
Study Director: Elizabeth Garner, MD, MPH Agile Therapeutics
Agile Therapeutics
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP