Transdermal Contraceptive Delivery System (TCDS), Also Known as AG200-15 Patch Arm
ATI-CL13
An Open-Label, Randomized, Phase 3 Study of the Contraceptive Efficacy and Safety of Agile Transdermal Contraceptive Delivery System in Comparison to an Oral Contraceptive (OC) Containing 150 mcg LNG and 30 mcg EE
1 other identifier
interventional
407
1 country
21
Brief Summary
The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2010
Shorter than P25 for phase_3
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 5, 2010
CompletedFirst Posted
Study publicly available on registry
November 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
September 15, 2017
CompletedSeptember 15, 2017
August 1, 2017
8 months
November 5, 2010
July 20, 2017
August 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pregnancy Reported as Pearl Index
Pearl Index is the number of on-therapy pregnancies times 1300 divided by the number of 28-day on-therapy cycles and is an estimate of the number of pregnancies per 100 woman-years of product use.
6 months
Secondary Outcomes (1)
Safety
6 months
Other Outcomes (4)
Cycle Control
6 months
Irritation and Itching at Application Site
6 months
Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE)
3 months and 6 months
- +1 more other outcomes
Study Arms (2)
AG200-15
EXPERIMENTALThin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)
Levora
ACTIVE COMPARATORoral contraceptive containing 150mcg of LNG and 30mcg of EE
Interventions
Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period.
One tablet of Levora will be taken each day for a 28 day cycle.
Eligibility Criteria
You may qualify if:
- sexually active women requesting contraception
- Regular menses every 24 - 35 days
- In good general health, confirmed by medical history, physical (including gynecologic examination adn screening laboratory values
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Unknown Facility
Mobile, Alabama, 36608, United States
Unknown Facility
Green Valley, Arizona, 85614, United States
Unknown Facility
Tucson, Arizona, 85712, United States
Unknown Facility
Los Angeles, California, 90036, United States
Unknown Facility
Los Angeles, California, 90057, United States
Unknown Facility
West Hills, California, 91307, United States
Unknown Facility
Boynton Beach, Florida, 33472, United States
Unknown Facility
South Miami, Florida, 33143, United States
Unknown Facility
St. Petersburg, Florida, 33709, United States
Unknown Facility
Newburgh, Indiana, 47630, United States
Unknown Facility
Louisville, Kentucky, 40291, United States
Unknown Facility
Las Vegas, Nevada, 89109, United States
Unknown Facility
Las Vegas, Nevada, 89128, United States
Unknown Facility
Kernersville, North Carolina, 27284, United States
Unknown Facility
Englewood, Ohio, 45322, United States
Unknown Facility
Tulsa, Oklahoma, 74105, United States
Unknown Facility
Mt. Pleasant, South Carolina, 29464, United States
Unknown Facility
Corpus Christi, Texas, 78414, United States
Unknown Facility
Sugar Land, Texas, 77479, United States
Unknown Facility
Newport News, Virginia, 23606, United States
Unknown Facility
Norfolk, Virginia, 23502, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lisa Flood, Associate Director of Clinical Operations
- Organization
- Agile Therapeutics
Study Officials
- STUDY DIRECTOR
Marie Foegh, MD
Agile Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2010
First Posted
November 9, 2010
Study Start
October 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
September 15, 2017
Results First Posted
September 15, 2017
Record last verified: 2017-08