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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01181479
Recruitment Status : Completed
First Posted : August 13, 2010
Last Update Posted : February 1, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Contraception Drug: AG200-15 transdermal patch Drug: Oral Contraceptive Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 1504 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : August 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : March 2012

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Pregnancy [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01181479

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Agile Therapeutics Identifier: NCT01181479     History of Changes
Other Study ID Numbers: ATI-CL12
57731 ( Other Identifier: FDA )
First Posted: August 13, 2010    Key Record Dates
Last Update Posted: February 1, 2013
Last Verified: January 2013

Keywords provided by Agile Therapeutics:

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