GA YAZ ACNE in China Phase III

A Multicenter, Double-blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of an Oral Contraceptive Preparation YAZ (Drospirenone 3 mg / Ethinylestradiol 20 µg) for 6 Treatment Cycles in Women With Moderate Acne

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.

Inclusion Criteria:

• Women of age 14-45 years
• >1 year post-menarche with moderate acne vulgaris who have no known contraindications to combined oral contraceptives
• Otherwise healthy, except for the presence of moderate acne
• Smokers up to a maximum age of 30 (inclusive) at inclusion

Exclusion Criteria:

• Pregnancy, lactation (less than three menstrual cycles since delivery, abortion, or lactation before start of treatment)
• Obesity (Body Mass Index > 30 kg/m2)
• Hypersensitivity to any ingredient of the study drug
• Any disease or condition that may worsen under hormonal treatment