Conditions: Contraception
Keywords: Contraception
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 1683
Healthy volunteers: yes

Brief summary:
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.

Detailed description:

Arms:
arm 1: Norethindrone/Ethinyl Estradiol

Interventions: intervention 1: Norethindrone acetate/ethinyl estradiol
Intervention descriptions: intervention 1: one tablet per day

Protocol document: