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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.
Information provided by (Responsible Party):
Agile Therapeutics Identifier:
First received: August 12, 2010
Last updated: January 30, 2013
Last verified: January 2013
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
Drug: AG200-15 transdermal patch
Drug: Oral Contraceptive
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
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.

Further study details as provided by Agile Therapeutics:

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

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).

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

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

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 )
Study First Received: August 12, 2010
Last Updated: January 30, 2013

Keywords provided by Agile Therapeutics:

Additional relevant MeSH terms:
Ethinyl Estradiol
Contraceptives, Oral
Contraceptive Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents, Female
Reproductive Control Agents processed this record on April 24, 2017