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

Completed · Phase 3

Conditions studied: Contraceptive Usage

In brief

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.

Key facts

Study ID

NCT01140217

Run by

Watson Pharmaceuticals

People needed

1659

Starts

2010-05-01

Expected to finish

2012-03-01

Last updated by the study team

2013-09-19

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Watson Investigational Site — Mobile, Alabama, United States
• Watson Investigational Site — Montgomery, Alabama, United States
• Watson Investigational Site — Chandler, Arizona, United States
• Watson Investigational Site — Little Rock, Arkansas, United States
• Watson Investigational Site — Garden Grove, California, United States
• Watson Investigational Site — La Mesa, California, United States
• Watson Investigational Site — San Diego, California, United States
• Watson Investigational Site — Denver, Colorado, United States
• Watson Investigational Site — Newark, Delaware, United States
• Watson Investigational Site — Washington D.C., District of Columbia, United States
• Watson Investigational Site — Aventura, Florida, United States
• Watson Investigational Site — Daytona Beach, Florida, United States
• Watson Investigational Site — Jacksonville, Florida, United States
• Watson Investigational Site — Lake Worth, Florida, United States
• Watson Investigational Site — Miami, Florida, United States
• Watson Investigational Site — North Miami, Florida, United States
• Watson Investigational Site — Pinellas Park, Florida, United States
• Watson Investigational Site — Sarasota, Florida, United States
• Watson Investigational Site — Atlanta, Georgia, United States
• Watson Investigational Site — Decatur, Georgia, United States
• Watson Investigational Site — Sandy Springs, Georgia, United States
• Watson Investigational Site — Savannah, Georgia, United States
• Watson Investigational Site — Chicago, Illinois, United States
• Watson Investigational Site — Overland Park, Kansas, United States
• Watson Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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