Conditions: Prevention of Pregnancy
Keywords: Contraception
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 938
Healthy volunteers: yes

Brief summary:
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.

Detailed description:

Arms:
arm 1: Norethindrone acetate 1 mg /ethinyl estradiol 20 mcg for 24 days of each 28 day cycle arm 2: Norethindrone acetate 1 mg/ethinyl estradiol 20 mcg for 21 days of each 28 day cycle

Interventions: intervention 1: Norethindrone Acetate/Ethinyl Estradiol 24 Days intervention 2: Norethindrone Acetate /Ethinyl Estradiol 21 Days
Intervention descriptions: intervention 1: One tablet per day for 24 days of each 28 day cycle followed by 4 placebo tablets intervention 2: One tablet per day for 21 days of each 28 day cycle followed by 7 placebo tablets

Protocol document: