| January 6, 2009 |
| January 20, 2010 |
| December 2008 |
| June 2010 (final data collection date for primary outcome measure) |
| The primary efficacy variable is the percent change from baseline to Cycle 6 in total lesion count. [ Time Frame: 6 cycles (1 cycle= 28 days) ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00818519 on ClinicalTrials.gov Archive Site |
- Percentage of patients classified as '0' or '1' on the 6-point Investigator Static Global Assessment scale [ Time Frame: 6 cycles ] [ Designated as safety issue: No ]
- Percent change from baseline in inflammatory lesion counts, non-inflammatory lesion counts [ Time Frame: 6 cycles ] [ Designated as safety issue: No ]
- Percent change from baseline in papules, pustules, nodules, open comedones, and closed comedones [ Time Frame: 6 cycles ] [ Designated as safety issue: No ]
- Percentage of patients showing improvement on the Investigator's Overall Improvement Rating and Subject's Overall Self-Assessment Rating [ Time Frame: 6 cycles ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: Whole study period ] [ Designated as safety issue: Yes ]
- Laboratory tests [ Time Frame: Whole study period ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| 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. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Acne Vulgaris |
- Drug: EE20/Drospirenone (YAZ, BAY86-5300)
20µg ethinylestradiol, 3mg drospirenone, tablet, orally, opd
- Drug: Placebo
Inert tablet
|
|
|
| |
| |
| Active, not recruiting |
| 166 |
| July 2010 |
| June 2010 (final data collection date for primary outcome measure) |
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
|
| Female |
| 14 Years to 45 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| China |
| |
| NCT00818519 |
| Therapeutic Area Head, Bayer Schering Pharma AG |
| 91772, 311963 |
| Bayer |
|
| Study Director: |
Bayer Study Director |
Bayer |
|
|
| Bayer |
| January 2010 |
