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COMPLETEDPhase 3NCT01140217

Efficacy and Safety Study of Norethindrone Acetate Transdermal Delivery System in Contraception

The purpose of this study is to determine whether NEA TDS is effective in the prevention of pregnancy. The safety of this product will also be evaluated.

Lead sponsor: Watson Pharmaceuticals•53 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Watson Pharmaceuticals

An Open Label Study to Evaluate the Contraceptive Efficacy and Safety of Norethindrone Acetate Transdermal Delivery System.

Age

18 - 45 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy females
•18-45 years
•Regular, consistent menstrual cycles between 25 and 35 days
•Sexually active and at risk of becoming pregnant

Exclusion Criteria

•History of infertility
•Known contraindications to progestogen administration
•Pap smear suggestive of a high-grade precancerous lesion(s)
•Clinically significant deviation from normal in any of the screening tests or exams

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: September 19, 2013Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment1,659

Start dateMay 2010

Last updatedSep 19, 2013

Condition

Contraceptive Usage

Locations shown

Watson Investigational Site

Birmingham, Alabama

Watson Investigational Site

Mobile, Alabama

Watson Investigational Site

Montgomery, Alabama

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2013Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions