Transdermal Contraceptive Delivery System (TCDS), Also Known as AG200-15 Patch Arm

Phase 3

Completed

• Conditions: Contraception
• Interventions: Drug: AG200-15; Drug: Levora

• Registration Number: NCT01236768
• 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, hormone related adverse events, lipid profile, cycle control (bleeding pattern), subject compliance and serum concentrations of EE and LNG. To evaluate TCDS wearability (including adhesion).

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-11-05
• Study First Submitted QC: 2010-11-05
• Study First Posted: 2010-11-09
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Disposition First Submitted: 2012-07-10
• Disposition First Submitted QC: 2013-01-28
• Disposition First Posted: 2013-01-30
• Results First Submitted: 2017-07-20
• Status Verified: 2017-08
• Results First Submitted QC: 2017-08-17
• Last Update Submitted: 2017-08-17
• Results First Posted: 2017-09-15
• Last Update Posted: 2017-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 407

Inclusion Criteria

• 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

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	AG200-15	Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)
Levora	Levora	oral contraceptive containing 150mcg of LNG and 30mcg of EE

Primary Outcome Measures

Name	Time	Method
Pregnancy Reported as Pearl Index	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Safety	6 months	Adverse events