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

NCT01236768 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 407

Last updated 2017-09-15

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

Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period.

DRUG

Levora

One tablet of Levora will be taken each day for a 28 day cycle.

Sponsors & Collaborators

  • Agile Therapeutics

    lead INDUSTRY

Principal Investigators

  • Marie Foegh, MD · Agile Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-06-30
Completion
2011-06-30

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 NCT01236768 on ClinicalTrials.gov