Trial Condition(s):

Acne vulgaris

GA YAZ ACNE in China Phase III

Bayer Identifier:

91772

ClinicalTrials.gov Identifier:

NCT00818519

EudraCT Number:

2014-004612-10

Study Completed

Trial Purpose

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

Trial Summary

Enrollment Goal
179
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
YAZ (EE20/DRSP, BAY86-5300)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

3rd Affiliated Hosp., Sun Yat-sen Univ.

Guangzhou, China, 510630

Status
Completed
 
Locations

Changhai Hospital of Second Military Medical University

Shanghai, China, 200043

Status
Completed
 
Locations

Dermatosis Graduate School of Chinese Academy of Medical Sc

Nanjing, China, 210042

Status
Completed
 
Locations

Peking Union Medical College Hospital

Beijing, China, 100032

Status
Completed
 
Locations

Chinese PLA General Hospital

Beijing, China, 100853

Status
Completed
 
Locations

2nd Xiangya Hosp., Central South Univ.

Changsha, China, 410011

Status
Completed
 
Locations

West China Hospital, Sichuan University

Chengdu, China, 610041

Status
Completed
 

Trial Design