Conditions: Dysmenorrhea
Keywords: Dysmenorrhea Dysmenorrheal score Drospirenone DRSP Ethinylestradiol
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 249
Healthy volunteers: no

Brief summary:
The purpose of this study is to investigate efficacy of drospirenone for dysmenorrhea.

Detailed description:

Arms:
arm 1: 1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle arm 2: 1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle arm 3: 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle arm 4: 1 tablet per day placebo for 28 days in each 28-day cycle

Interventions: intervention 1: SH T04740B intervention 2: SH T00186DF intervention 3: SH T04740F intervention 4: Placebo
Intervention descriptions: intervention 1: Drospirenone 1mg/EE 20µg (ß-CDC) intervention 2: Drospirenone 3 mg/EE 20µg (ß-CDC) intervention 3: Drospirenone 2 mg/EE 20µg (ß-CDC) intervention 4: Placebo

Protocol document: