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

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ClinicalTrials.gov Identifier: NCT01181479
Recruitment Status : Completed
First Posted : August 13, 2010
Last Update Posted : February 1, 2013
Sponsor:
Information provided by (Responsible Party):
Agile Therapeutics

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
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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
Arms and Interventions
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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


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

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT01181479


  Show 80 Study Locations
Sponsors and Collaborators
Agile Therapeutics
Investigators
Study Director: Marie Foegh, MD, DrSc Agile Therapeutics
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Agile Therapeutics
ClinicalTrials.gov 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:
Contraceptive

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