GA YAZ ACNE in China Phase III

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Contraceptive Agents; Contraceptives, Oral; Drospirenone; Ethinyl Estradiol

Criteria

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