Status:
COMPLETED
Efficacy and Safety Study of Norethindrone Acetate Transdermal Delivery System in Contraception
Lead Sponsor:
Watson Pharmaceuticals
Conditions:
Contraceptive Usage
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- Healthy females
- 18-45 years
- Regular, consistent menstrual cycles between 25 and 35 days
- Sexually active and at risk of becoming pregnant
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
1659 Patients enrolled
Trial Details
Trial ID
NCT01140217
Start Date
May 1 2010
End Date
March 1 2012
Last Update
September 19 2013
Active Locations (53)
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1
Watson Investigational Site
Birmingham, Alabama, United States
2
Watson Investigational Site
Mobile, Alabama, United States
3
Watson Investigational Site
Montgomery, Alabama, United States
4
Watson Investigational Site
Chandler, Arizona, United States