GA YAZ ACNE in China Phase III
Information source: Bayer
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acne Vulgaris
Intervention: EE20/Drospirenone (YAZ, BAY86-5300) (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
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.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary efficacy variable is the percent change from baseline to Cycle 6 in total lesion count.
Secondary outcome: Percentage of patients classified as '0' or '1' on the 6-point Investigator Static Global Assessment scalePercent change from baseline in inflammatory lesion counts, non-inflammatory lesion counts Percent change from baseline in papules, pustules, nodules, open comedones, and closed comedones Percentage of patients showing improvement on the Investigator's Overall Improvement Rating and Subject's Overall Self-Assessment Rating Adverse events Laboratory tests
Eligibility
Minimum age: 14 Years.
Maximum age: 45 Years.
Gender(s): Female.
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
Locations and Contacts
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Beijing 100730, China; Recruiting
Beijing 100853, China; Recruiting
Shanghai 200433, China; Recruiting
Guangzhou, Guangdong 510630, China; Recruiting
Changsha, Hunan 410013, China; Recruiting
Nanjing, Jiangsu 210042, China; Recruiting
Chengdu, Sichuan 610041, China; Recruiting
Additional Information
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Starting date: December 2008
Ending date: July 2010
Last updated: September 30, 2009
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