Conditions: Acne Vulgaris
Keywords: Moderate Acne Vulgaris Oral contraceptive Female
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 179
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of YAZ (drospirenone 3 mg / ethinylestradiol 20 µg) in comparison with placebo in female patients with moderate acne vulgaris over 6 treatment cycles.

Detailed description:

Arms:
arm 1: In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol). arm 2: The participants of the placebo group received inert but identical-appearing, color-matched tablets.

Interventions: intervention 1: EE20/Drospirenone (YAZ, BAY86-5300) intervention 2: Placebo
Intervention descriptions: intervention 1: 20µg ethinylestradiol, 3mg drospirenone, tablet, orally, opd intervention 2: Inert tablet

Protocol document: