Study of Safety and Efficacy of an Oral Contraceptive

Warner Chilcott

Status and phase: Completed; Phase 3

Conditions: Prevention of Pregnancy

Treatments: Drug: Norethindrone Acetate/Ethinyl Estradiol 24 Days; Drug: Norethindrone Acetate /Ethinyl Estradiol 21 Days

Study type: Interventional

Funder types: Industry

Identifiers

NCT00932321

PR-03903

Details and patient eligibility

About

This is a 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 of norethindrone acetate/ethinyl estradiol (NETA/EE) administered for 24 days and NETA/EE administered for 21 days; and to assess the safety and tolerability of the product.

Enrollment: 938 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: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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938 participants in 2 patient groups

24 Day NA/EE

Experimental group

Description:

Norethindrone acetate 1 mg /ethinyl estradiol 20 mcg for 24 days of each 28 day cycle

Treatment:

Drug: Norethindrone Acetate/Ethinyl Estradiol 24 Days

21 Day NA/EE

Active Comparator group

Description:

Norethindrone acetate 1 mg/ethinyl estradiol 20 mcg for 21 days of each 28 day cycle

Treatment:

Drug: Norethindrone Acetate /Ethinyl Estradiol 21 Days