Clinical trial NCT01181479: Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Keywords: Contraceptive
Lead sponsor: Agile Therapeutics
Sponsor class: INDUSTRY
First posted: 2010-08-13
Enrollment: 1504
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Comparative evaluation of AG200-15 versus OC with regard to safety, contraceptive efficacy, cycle control (bleeding pattern), subject compliance and serum concentrations of EE and LNG. To evaluate TCDS wearability (including adhesion).

Eligibility criteria: Inclusion Criteria:

Healthy females

* 17(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

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

Primary outcomes:
measure: Pregnancy
timeFrame: AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year
Secondary outcomes:
Other outcomes:
measure: Cycle Control
timeFrame: 6 months
measure: Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE)
timeFrame: Lessina: 6 months; AG200-15: 1 year; AG200-15: 6 months
measure: Self-reported Irritation at Application Site
timeFrame: 1 year
measure: Patch Adhesion by Investigator Evaluation at Each Visit
timeFrame: 1 year
measure: Self-reported Itching at Patch Application Site
timeFrame: 1 year
Locations:
city: Huntsville
country: United States
facility: Agile Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Agile Investigational Site
state: Alabama
city: Chandler
country: United States
facility: Agile Investigational Site
state: Arizona
city: Green Valley
country: United States
facility: Agile Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Agile Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Agile Investigational Site
state: Arkansas
city: La Mesa
country: United States
facility: Agile Investigational Site
state: California
city: Los Angeles
country: United States
facility: Agile Investigational Site
state: California
city: Sacramento
country: United States
facility: Agile Investigational
state: California
city: San Diego
country: United States
facility: Agile Investigational Site
state: California
city: Santa Ana
country: United States
facility: Agile Investigational Site
state: California
city: Vista
country: United States
facility: Agile Investigational Site
state: California
city: West Hills
country: United States
facility: Agile Investigational Site
state: California
city: Boulder
country: United States
facility: Agile Investigational Site
state: Colorado
city: Colorado Springs
country: United States
facility: Agile Investigational Site
state: Colorado
city: Denver
country: United States
facility: Agile Investigational Site
state: Colorado
city: Fort Collins
country: United States
facility: Agile Investigational Site
state: Colorado
city: Wheat Ridge
country: United States
facility: Agile Investigational Site
state: Colorado
city: Milford
country: United States
facility: Agile Investigational Site
state: Connecticut
city: New London
country: United States
facility: Agile Investigational Site
state: Connecticut
city: Waterbury
country: United States
facility: Agile Investigational Site
state: Connecticut
city: Boynton Beach
country: United States
facility: Agile Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Agile Investigational Site
state: Florida
city: Daytona Beach
country: United States
facility: Agile Investigational Site
state: Florida
city: DeLand
country: United States
facility: Agile Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: Agile Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Agile Investigational Site
state: Florida
city: Pinellas Park
country: United States
facility: Agile Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: Agile Investigational Site
state: Florida
city: South Miami
country: United States
facility: Agile Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Agile Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Agile Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Agile Investigational Site
state: Georgia
city: Sandy Springs
country: United States
facility: Agile Investigational Site
state: Georgia
city: Champaign
country: United States
facility: Agile Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Agile Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Agile Investigational Site
state: Indiana
city: Newburgh
country: United States
facility: Agile Investigational Site
state: Indiana
city: Overland Park
country: United States
facility: Agile Investigational Site
state: Kansas
city: Wichita
country: United States
facility: Agile Investigational Site
state: Kansas
city: Lexington
country: United States
facility: Agile Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Agile Investigational Site
state: Kentucky
city: Marrero
country: United States
facility: Agile Investigational Site
state: Louisiana
city: Lincoln
country: United States
facility: Agile Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Agile Investigational Site
state: Nevada
city: Edison
country: United States
facility: Agile Investigational Site
state: New Jersey
city: Lawrenceville
country: United States
facility: Agile Investigational Site
state: New Jersey
city: Rochester
country: United States
facility: Agile Investigational Site
state: New York
city: Cary
country: United States
facility: Agile Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Agile Investigational Site
state: North Carolina
city: Kernersville
country: United States
facility: Agile Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Agile Investigational Site
state: North Carolina
city: Salisbury
country: United States
facility: Agile Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: Agile Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Agile Investigational Site
state: North Carolina
city: Akron
country: United States
facility: Agile Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Agile Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Agile Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Agile Investigational Site
state: Ohio
city: Englewood
country: United States
facility: Agile Investigational Site
state: Ohio
city: Mayfield Heights
country: United States
facility: Agile Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Agile Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Agile Investigational Site
state: Oklahoma
city: Medford
country: United States
facility: Agile Investigational Site
state: Oregon
city: Jackson
country: United States
facility: Agile Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: Agile Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Agile Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Agile Investigational Site
state: Texas
city: Bedford
country: United States
facility: Agile Investigational Site
state: Texas
city: Corpus Christi
country: United States
facility: Agile Investigational Site
state: Texas
city: Dallas
country: United States
facility: Agile Investigational Site
state: Texas
city: Houston
country: United States
facility: Agile Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Agile Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: Agile Investigational Site
state: Texas
city: Webster
country: United States
facility: Agile Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Agile Investigational Site
state: Utah
city: Newport News
country: United States
facility: Agile Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Agile Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Agile Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Agile Investigational Site
state: Washington
Study officials:
affiliation: Agile Therapeutics
name: Elizabeth Garner, MD, MPH
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Kaunitz 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.
citation: Kaunitz 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.