Conditions: Primary Dysmenorrhea
Keywords: Primary Dysmenorrhea Oral Contraception
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 507
Healthy volunteers: yes

Brief summary:
To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on alleviating complaints of dysmenorrhea associated with oral contraceptive use.

Detailed description:

Arms:
arm 1: Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles arm 2: Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles

Interventions: intervention 1: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) intervention 2: Ethinyl estradiol, Levonorgestrel (Miranova) intervention 3: Placebo Match to SH T00658ID intervention 4: Placebo Match to SH D593B
Intervention descriptions: intervention 1: Daily oral administration of one tablet SH T00658ID for 28 days per cycle in the respective treatment period; no tablet-free interval intervention 2: Daily oral administration of one tablet for 28 days per cycle in the respective treatment period; no tablet-free interval intervention 3: Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles. intervention 4: Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.

Protocol document: