Conditions: Contraception
Keywords: pregnancy prevention oral contraceptives
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 2235
Healthy volunteers: yes

Brief summary:
This is an open-label, single treatment study. All subjects will receive one year of oral contraceptive therapy with DR-1011. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.

Detailed description:

Arms:
arm 1: Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.

Interventions: intervention 1: DR-1011
Intervention descriptions: intervention 1: Eighty-four orange, embossed tablets, each containing 100 μg levonorgestrel (LNG) / 20 μg ethinyl estradiol (EE) and 7 yellow, embossed tablets, each containing 10 μg of EE. One combination tablet was to be taken each day for 84 days followed by 7 days of EE tablets in 91-day cycles repeated consecutively for approximately one year (four 91-day cycles).

Protocol document: