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

Phase 3

Completed

• Conditions: Contraceptive Usage
• Interventions: Drug: Norethindrone Acetate

• Registration Number: NCT01140217
• Lead Sponsor: Watson Pharmaceuticals

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-18
• Study First Submitted QC: 2010-06-07
• Study First Posted: 2010-06-09
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Disposition First Submitted: 2013-06-03
• Disposition First Submitted QC: 2013-06-03
• Disposition First Posted: 2013-06-11
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-13
• Last Update Posted: 2013-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1659

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active treatment	Norethindrone Acetate	Norethindrone Acetate Transdermal Delivery System

Primary Outcome Measures

Name	Time	Method
Pregnancy Rate	1 year	The pregnancy rate will be calculated using the Pearl Index that defined as 1300\*Number of pregnancies/Number of cycles of treatment.

Trial Locations

Locations (1)

Watson Investigational Site; 🇺🇸 Seattle, Washington, United States