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

NCT01181479 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1504

Last updated 2018-07-03

Study results available
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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.

Conditions

  • Contraception

Interventions

DRUG

AG200-15 (cycles 1-13)

AG200-15 containing ethinyl estradiol and levonorgestrel

DRUG

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.

Sponsors & Collaborators

  • Agile Therapeutics

    lead INDUSTRY

Principal Investigators

  • Elizabeth Garner, MD, MPH · Agile Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-12-31
Completion
2012-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01181479 on ClinicalTrials.gov