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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

Brief Summary:
Pharmacokinetics and safety of AG200-15 over two consecutive cycles of therapy will be evaluated.

Condition or disease Intervention/treatment Phase
Healthy Drug: Ortho-Cyclen Drug: AG200-15 Phase 1

Detailed Description:

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).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : August 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ortho-Cyclen®
Ortho-Cyclen® is a comparator drug intervention
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

Experimental: AG200-15
AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).

  8. 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).

  9. 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).

  10. 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).

  11. 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.

  12. 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.

  13. 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).



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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): NCT01243580


Locations
United States, Florida
Miami, Florida, United States, 33169
Sponsors and Collaborators
Agile Therapeutics
Investigators
Study Director: Elizabeth Garner, MD, MPH Agile Therapeutics

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Agile Therapeutics
ClinicalTrials.gov Identifier: NCT01243580     History of Changes
Other Study ID Numbers: ATI-CL14
First Posted: November 18, 2010    Key Record Dates
Results First Posted: December 19, 2017
Last Update Posted: January 23, 2018
Last Verified: December 2017

Keywords provided by Agile Therapeutics:
PK and safety
Pharmacokinetic profile (PK) and safety

Additional relevant MeSH terms:
Estradiol
Ethinyl Estradiol
Contraceptive Agents
Norgestimate, ethinyl estradiol drug combination
Ethinyl estradiol, levonorgestrel drug combination
Contraceptives, Oral
Moxifloxacin
Fluoroquinolones
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Combined
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nucleic Acid Synthesis Inhibitors