Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System
Open-label, Randomized, Parallel Group, Study of Efficacy and Safety of a Transdermal Contraceptive Delivery System (TCDS) in Comparison to a Low-dose Oral Contraceptive Containing 0.02 mg EE and 0.1 mg LNG in a 21-day Regimen.
2 other identifiers
interventional
1,504
1 country
80
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 P75+ for phase_3
Started Aug 2010
80 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 12, 2010
CompletedFirst Posted
Study publicly available on registry
August 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
July 3, 2018
CompletedJuly 3, 2018
July 1, 2018
1.3 years
August 12, 2010
July 21, 2017
July 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pregnancy
Pregnancy outcomes was determine by measuring 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.
AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year
Other Outcomes (5)
Cycle Control
6 months
Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE)
Lessina: 6 months; AG200-15: 1 year; AG200-15: 6 months
Self-reported Irritation at Application Site
1 year
- +2 more other outcomes
Study Arms (2)
AG200-15 (cycles 1-13)
EXPERIMENTALAG200-15 containing ethinyl estradiol and levonorgestrel. Type of intervention is drug.
Lessina crossover to AG200-15
ACTIVE COMPARATORLessina containing ethinyl estradiol and levonorgestrel for 6 cycles followed by AG200-15 for 6 cycles. Type of intervention is drug.
Interventions
AG200-15 containing ethinyl estradiol and levonorgestrel
Low dose oral contraceptive containing 20 mcg ethinyl estradiol and 100 mcg Levonorgestrel in 21 day regimen for 6 cycles followed by AG200-15 for 6 cycles.
Eligibility Criteria
You may qualify if:
- Healthy females
- (in states where the legal age of consent to receive contraceptives is 17)-40 years
- Regular, consistent menstrual cycles between 25 and 35 days
- Sexually active women requesting birth control
- In good general health, confirmed by medical history, physical (including gynecologic) examination and 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 (80)
Agile Investigational Site
Huntsville, Alabama, 35801, United States
Agile Investigational Site
Mobile, Alabama, 36608, United States
Agile Investigational Site
Chandler, Arizona, 85224, United States
Agile Investigational Site
Green Valley, Arizona, 85614, United States
Agile Investigational Site
Tucson, Arizona, 85712, United States
Agile Investigational Site
Little Rock, Arkansas, 72205, United States
Agile Investigational Site
La Mesa, California, 91942, United States
Agile Investigational Site
Los Angeles, California, 90057, United States
Agile Investigational
Sacramento, California, 95831, United States
Agile Investigational Site
San Diego, California, 92103, United States
Agile Investigational Site
Santa Ana, California, 92705, United States
Agile Investigational Site
Vista, California, 92083, United States
Agile Investigational Site
West Hills, California, 91307, United States
Agile Investigational Site
Boulder, Colorado, 80302, United States
Agile Investigational Site
Colorado Springs, Colorado, 80907, United States
Agile Investigational Site
Denver, Colorado, 80207, United States
Agile Investigational Site
Fort Collins, Colorado, 80524, United States
Agile Investigational Site
Wheat Ridge, Colorado, 80033, United States
Agile Investigational Site
Milford, Connecticut, 06460, United States
Agile Investigational Site
New London, Connecticut, 06320, United States
Agile Investigational Site
Waterbury, Connecticut, 06708, United States
Agile Investigational Site
Boynton Beach, Florida, 33472, United States
Agile Investigational Site
Clearwater, Florida, 33759, United States
Agile Investigational Site
Daytona Beach, Florida, 32114, United States
Agile Investigational Site
DeLand, Florida, 32720, United States
Agile Investigational Site
Fort Myers, Florida, 33916, United States
Agile Investigational Site
Jacksonville, Florida, 32207, United States
Agile Investigational Site
Pinellas Park, Florida, 33781, United States
Agile Investigational Site
South Miami, Florida, 33143, United States
Agile Investigational Site
St. Petersburg, Florida, 33709, United States
Agile Investigational Site
West Palm Beach, Florida, 33409, United States
Agile Investigational Site
Atlanta, Georgia, 30342, United States
Agile Investigational Site
Decatur, Georgia, 30034, United States
Agile Investigational Site
Sandy Springs, Georgia, 30328, United States
Agile Investigational Site
Champaign, Illinois, 61820, United States
Agile Investigational Site
Chicago, Illinois, 60654, United States
Agile Investigational Site
Indianapolis, Indiana, 46250, United States
Agile Investigational Site
Newburgh, Indiana, 47630, United States
Agile Investigational Site
Overland Park, Kansas, 66202, United States
Agile Investigational Site
Wichita, Kansas, 67205, United States
Agile Investigational Site
Lexington, Kentucky, 40509, United States
Agile Investigational Site
Louisville, Kentucky, 40291, United States
Agile Investigational Site
Marrero, Louisiana, 70072, United States
Agile Investigational Site
Lincoln, Nebraska, 68510, United States
Agile Investigational Site
Las Vegas, Nevada, 89106, United States
Agile Investigational Site
Edison, New Jersey, 08817, United States
Agile Investigational Site
Lawrenceville, New Jersey, 08648, United States
Agile Investigational Site
Rochester, New York, 14609, United States
Agile Investigational Site
Cary, North Carolina, 27518, United States
Agile Investigational Site
Charlotte, North Carolina, 28209, United States
Agile Investigational Site
Kernersville, North Carolina, 27284, United States
Agile Investigational Site
Raleigh, North Carolina, 27609, United States
Agile Investigational Site
Salisbury, North Carolina, 28144, United States
Agile Investigational Site
Wilmington, North Carolina, 28401, United States
Agile Investigational Site
Winston-Salem, North Carolina, 27103, United States
Agile Investigational Site
Akron, Ohio, 44311, United States
Agile Investigational Site
Cincinnati, Ohio, 45267, United States
Agile Investigational Site
Cleveland, Ohio, 44122, United States
Agile Investigational Site
Columbus, Ohio, 43213, United States
Agile Investigational Site
Englewood, Ohio, 45322, United States
Agile Investigational Site
Mayfield Heights, Ohio, 44124, United States
Agile Investigational Site
Oklahoma City, Oklahoma, 73112, United States
Agile Investigational Site
Tulsa, Oklahoma, 74105, United States
Agile Investigational Site
Medford, Oregon, 97504, United States
Agile Investigational Site
Jackson, Tennessee, 38305, United States
Agile Investigational Site
Knoxville, Tennessee, 37920, United States
Agile Investigational Site
Memphis, Tennessee, 38120, United States
Agile Investigational Site
Austin, Texas, 78702, United States
Agile Investigational Site
Bedford, Texas, 76022, United States
Agile Investigational Site
Corpus Christi, Texas, 78414, United States
Agile Investigational Site
Dallas, Texas, 75231, United States
Agile Investigational Site
Houston, Texas, 77089, United States
Agile Investigational Site
San Antonio, Texas, 78229, United States
Agile Investigational Site
Sugar Land, Texas, 77479, United States
Agile Investigational Site
Webster, Texas, 77598, United States
Agile Investigational Site
Salt Lake City, Utah, 84109, United States
Agile Investigational Site
Newport News, Virginia, 23606, United States
Agile Investigational Site
Norfolk, Virginia, 23502, United States
Agile Investigational Site
Richmond, Virginia, 23294, United States
Agile Investigational Site
Seattle, Washington, 98105, United States
Related Publications (3)
Kaunitz AM, Portman D, Westhoff CL, Mishell DR Jr, Archer DF, Foegh M. New contraceptive patch wearability assessed by investigators and participants in a randomized phase 3 study. Contraception. 2015 Mar;91(3):211-6. doi: 10.1016/j.contraception.2014.11.013. Epub 2014 Nov 25.
PMID: 25586864DERIVEDKaunitz AM, Portman D, Westhoff CL, Archer DF, Mishell DR Jr, Foegh M. Self-reported and verified compliance in a phase 3 clinical trial of a novel low-dose contraceptive patch and pill. Contraception. 2015 Mar;91(3):204-10. doi: 10.1016/j.contraception.2014.11.011. Epub 2014 Nov 25.
PMID: 25582984DERIVEDKaunitz AM, Portman D, Westhoff CL, Archer DF, Mishell DR Jr, Rubin A, Foegh M. Low-dose levonorgestrel and ethinyl estradiol patch and pill: a randomized controlled trial. Obstet Gynecol. 2014 Feb;123(2 Pt 1):295-303. doi: 10.1097/AOG.0000000000000095.
PMID: 24402597DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Joseph Chiodo III, Senior Medical Director
- Organization
- Agile Therapeutics
Study Officials
- STUDY DIRECTOR
Elizabeth Garner, MD, MPH
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
August 12, 2010
First Posted
August 13, 2010
Study Start
August 1, 2010
Primary Completion
December 1, 2011
Study Completion
March 1, 2012
Last Updated
July 3, 2018
Results First Posted
July 3, 2018
Record last verified: 2018-07