Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System

Contraception Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01181479
• Other study ID #: ATI-CL12
• Secondary ID: 57731
• Status: Completed
• Phase: Phase 3
• Start date: August 2010
• Est. completion date: March 2012

Study information

• Verified date: July 2018
• Source: Agile Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1504
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 17 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• AG200-15 (cycles 1-13)
AG200-15 containing ethinyl estradiol and levonorgestrel
• Lessina crossover to AG200-15
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.

Locations

Country	Name	City	State
United States	Agile Investigational Site	Akron	Ohio
United States	Agile Investigational Site	Atlanta	Georgia
United States	Agile Investigational Site	Austin	Texas
United States	Agile Investigational Site	Bedford	Texas
United States	Agile Investigational Site	Boulder	Colorado
United States	Agile Investigational Site	Boynton Beach	Florida
United States	Agile Investigational Site	Cary	North Carolina
United States	Agile Investigational Site	Champaign	Illinois
United States	Agile Investigational Site	Chandler	Arizona
United States	Agile Investigational Site	Charlotte	North Carolina
United States	Agile Investigational Site	Chicago	Illinois
United States	Agile Investigational Site	Cincinnati	Ohio
United States	Agile Investigational Site	Clearwater	Florida
United States	Agile Investigational Site	Cleveland	Ohio
United States	Agile Investigational Site	Colorado Springs	Colorado
United States	Agile Investigational Site	Columbus	Ohio
United States	Agile Investigational Site	Corpus Christi	Texas
United States	Agile Investigational Site	Dallas	Texas
United States	Agile Investigational Site	Daytona Beach	Florida
United States	Agile Investigational Site	Decatur	Georgia
United States	Agile Investigational Site	DeLand	Florida
United States	Agile Investigational Site	Denver	Colorado
United States	Agile Investigational Site	Edison	New Jersey
United States	Agile Investigational Site	Englewood	Ohio
United States	Agile Investigational Site	Fort Collins	Colorado
United States	Agile Investigational Site	Fort Myers	Florida
United States	Agile Investigational Site	Green Valley	Arizona
United States	Agile Investigational Site	Houston	Texas
United States	Agile Investigational Site	Huntsville	Alabama
United States	Agile Investigational Site	Indianapolis	Indiana
United States	Agile Investigational Site	Jackson	Tennessee
United States	Agile Investigational Site	Jacksonville	Florida
United States	Agile Investigational Site	Kernersville	North Carolina
United States	Agile Investigational Site	Knoxville	Tennessee
United States	Agile Investigational Site	La Mesa	California
United States	Agile Investigational Site	Las Vegas	Nevada
United States	Agile Investigational Site	Lawrenceville	New Jersey
United States	Agile Investigational Site	Lexington	Kentucky
United States	Agile Investigational Site	Lincoln	Nebraska
United States	Agile Investigational Site	Little Rock	Arkansas
United States	Agile Investigational Site	Los Angeles	California
United States	Agile Investigational Site	Louisville	Kentucky
United States	Agile Investigational Site	Marrero	Louisiana
United States	Agile Investigational Site	Mayfield Heights	Ohio
United States	Agile Investigational Site	Medford	Oregon
United States	Agile Investigational Site	Memphis	Tennessee
United States	Agile Investigational Site	Milford	Connecticut
United States	Agile Investigational Site	Mobile	Alabama
United States	Agile Investigational Site	New London	Connecticut
United States	Agile Investigational Site	Newburgh	Indiana
United States	Agile Investigational Site	Newport News	Virginia
United States	Agile Investigational Site	Norfolk	Virginia
United States	Agile Investigational Site	Oklahoma City	Oklahoma
United States	Agile Investigational Site	Overland Park	Kansas
United States	Agile Investigational Site	Pinellas Park	Florida
United States	Agile Investigational Site	Raleigh	North Carolina
United States	Agile Investigational Site	Richmond	Virginia
United States	Agile Investigational Site	Rochester	New York
United States	Agile Investigational	Sacramento	California
United States	Agile Investigational Site	Saint Petersburg	Florida
United States	Agile Investigational Site	Salisbury	North Carolina
United States	Agile Investigational Site	Salt Lake City	Utah
United States	Agile Investigational Site	San Antonio	Texas
United States	Agile Investigational Site	San Diego	California
United States	Agile Investigational Site	Sandy Springs	Georgia
United States	Agile Investigational Site	Santa Ana	California
United States	Agile Investigational Site	Seattle	Washington
United States	Agile Investigational Site	South Miami	Florida
United States	Agile Investigational Site	Sugar Land	Texas
United States	Agile Investigational Site	Tucson	Arizona
United States	Agile Investigational Site	Tulsa	Oklahoma
United States	Agile Investigational Site	Vista	California
United States	Agile Investigational Site	Waterbury	Connecticut
United States	Agile Investigational Site	Webster	Texas
United States	Agile Investigational Site	West Hills	California
United States	Agile Investigational Site	West Palm Beach	Florida
United States	Agile Investigational Site	Wheat Ridge	Colorado
United States	Agile Investigational Site	Wichita	Kansas
United States	Agile Investigational Site	Wilmington	North Carolina
United States	Agile Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Agile Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cycle Control	Measuring the breakthrough bleeding (BTB) and/or breakthrough spotting (BTS). Measured as a percent of total number of cycles in each Arm/Group with BTB and/or BTS.	6 months
Other	Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE)	Measurement of plasma concentrations of LNG and EE for cycles 2, 6 and 13.	Lessina: 6 months; AG200-15: 1 year; AG200-15: 6 months
Other	Self-reported Irritation at Application Site	Evaluation of irritation at application site was determined using the following scores: 0: None; Mild; Moderate; Severe	1 year
Other	Patch Adhesion by Investigator Evaluation at Each Visit	Evaluation of patch adhesion was determined using the following scores: 0: >= 90% adhered (no lift); >= 75% adhered but < 90% (some edges showing lift); >= 50% adhered but < 75% (half of system lifts off); < 50% (> half of system lifts off, but undetached); patch completely detached	1 year
Other	Self-reported Itching at Patch Application Site	Evaluation of itching at patch application site was determined using the following scores: 0: None; Mild; Moderate; Severe	1 year
Primary	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