Conditions: Contraception
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 110
Healthy volunteers: yes

Brief summary:
The primary purpose of this study is to evaluate the effects of the NOMAC-E2 combined oral contraceptive (COC) on bone mineral density (BMD).

Detailed description:

Arms:
arm 1: Nomegestrol Acetate (NOMAC) and Estradiol (E2), 2.5 mg NOMAC and 1.5 mg E2 monophasic COC arm 2: Levonorgestrel (LNG) and Ethinyl Estradiol (EE), 0.150 mg LNG and 0.030 mg EE monophasic COC

Interventions: intervention 1: NOMAC-E2 intervention 2: LNG-EE
Intervention descriptions: intervention 1: Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 26 consecutive 28-day menstrual cycles (2 years). intervention 2: Levonorgestrel and Ethinyl Estradiol Tablets, 0.150 mg Levonorgestrel and 0.030 mg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 for 26 consecutive 28-day menstrual cycles (2 years).

Protocol document: