Status:
COMPLETED
GA YAZ ACNE in China Phase III
Lead Sponsor:
Bayer
Conditions:
Acne Vulgaris
Eligibility:
FEMALE
14-45 years
Phase:
PHASE3
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 tr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT00818519
Start Date
December 1 2008
End Date
May 1 2010
Last Update
August 25 2015
Active Locations (7)
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1
Guangzhou, Guangdong, China, 510630
2
Changsha, Hunan, China, 410011
3
Nanjing, Jiangsu, China, 210042
4
Chengdu, Sichuan, China, 610041