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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Agile Therapeutics
ClinicalTrials.gov Identifier:
NCT01181479
First received: August 12, 2010
Last updated: January 30, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Contraception
 Drug: AG200-15 transdermal patch
Drug: Oral Contraceptive
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Further study details as provided by Agile Therapeutics:

Primary Outcome Measures:
  • Pregnancy [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 1504
Study Start Date: August 2010
Study Completion Date: March 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AG200-15
Transdermal patch contiaing ethinyl estradiol and levornorgestrel
 Drug: AG200-15 transdermal patch
Transdermal patch containing ethinyl estradiol and levonorgestrel
Active Comparator: Lessina
Low dose oral pill containing Ethinyl estardiol and levorgestgrel
 Drug: Oral Contraceptive
Low dose oral contraceptive containing 20 mcg ethinyl estradiol and 100 mcg Levonorgestrel in 21 day regimen

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).

  Eligibility

Ages Eligible for Study:   17 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181479

  Show 80 Study Locations
Sponsors and Collaborators
Agile Therapeutics
Investigators
Study Director: Marie Foegh, MD, DrSc Agile Therapeutics
  More Information

No publications provided

Responsible Party: Agile Therapeutics
ClinicalTrials.gov Identifier: NCT01181479     History of Changes
Other Study ID Numbers: ATI-CL12, 57731
Study First Received: August 12, 2010
Last Updated: January 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Agile Therapeutics:
Contraceptive

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Ethinyl Estradiol
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Therapeutic Uses
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 16, 2013