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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Watson Pharmaceuticals
• Treatments: Norethindrone; Norethindrone Acetate

Criteria

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