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

Phase 3

Completed

• Conditions: Contraception
• Interventions: Drug: AG200-15 (cycles 1-13); Drug: Lessina crossover to AG200-15

• Registration Number: NCT01181479
• Lead Sponsor: Agile Therapeutics

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).

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-12
• Study First Submitted QC: 2010-08-12
• Study First Posted: 2010-08-13
• Primary Completion: 2011-12
• Study Completion: 2012-03
• Disposition First Submitted: 2013-01-22
• Disposition First Submitted QC: 2013-01-30
• Disposition First Posted: 2013-02-01
• Results First Submitted: 2017-07-21
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-02
• Last Update Submitted: 2018-07-02
• Results First Posted: 2018-07-03
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1504

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AG200-15 (cycles 1-13)	AG200-15 (cycles 1-13)	AG200-15 containing ethinyl estradiol and levonorgestrel. Type of intervention is drug.
Lessina crossover to AG200-15	Lessina crossover to AG200-15	Lessina containing ethinyl estradiol and levonorgestrel for 6 cycles followed by AG200-15 for 6 cycles. Type of intervention is drug.

Primary Outcome Measures

Name	Time	Method
Pregnancy	AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year	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.

Trial Locations

Locations (2)

Agile Investigational Site; 🇺🇸 Seattle, Washington, United States

Agile Investigational; 🇺🇸 Sacramento, California, United States