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

Watson Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Contraceptive Usage

Treatments: Drug: Norethindrone Acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01140217

NE0906

Details and patient eligibility

About

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.

Full description

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

Enrollment: 1,659 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,659 participants in 1 patient group

Active treatment

Experimental group

Description:

Norethindrone Acetate Transdermal Delivery System

Treatment:

Drug: Norethindrone Acetate