Study of Safety and Efficacy of an Oral Contraceptive

Warner Chilcott

Status and phase: Completed; Phase 3

Conditions: Contraception

Treatments: Drug: Norethindrone acetate/ethinyl estradiol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00391807

PR-05806

Details and patient eligibility

About

This is a non-comparative study. The primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of the product.

Enrollment: 1,683 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Women
• Age 18-45
• At risk for pregnancy
• History of regular cycles

Exclusion criteria

• Contraindications for use of hormonal contraception
• Conditions which affect the absorption or metabolism of steroid hormones
• BMI > 35

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,683 participants in 1 patient group

study drug

Experimental group

Description:

Norethindrone/Ethinyl Estradiol

Treatment:

Drug: Norethindrone acetate/ethinyl estradiol