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| Sponsor: | Bayer |
|---|---|
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00818519 |
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acne Vulgaris |
Drug: EE20/Drospirenone (YAZ, BAY86-5300) Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Enrollment: | 166 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Arm 1: Experimental |
Drug: EE20/Drospirenone (YAZ, BAY86-5300)
20µg ethinylestradiol, 3mg drospirenone, tablet, orally, opd
|
| Arm 2: Placebo Comparator |
Drug: Placebo
Inert tablet
|
Eligibility| Ages Eligible for Study: | 14 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| China | |
| Beijing, China, 100730 | |
| Beijing, China, 100853 | |
| Shanghai, China, 200433 | |
| China, Guangdong | |
| Guangzhou, Guangdong, China, 510630 | |
| China, Hunan | |
| Changsha, Hunan, China, 410013 | |
| China, Jiangsu | |
| Nanjing, Jiangsu, China, 210042 | |
| China, Sichuan | |
| Chengdu, Sichuan, China, 610041 | |
| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Bayer Schering Pharma AG ( Therapeutic Area Head ) |
| Study ID Numbers: | 91772, 311963 |
| Study First Received: | January 6, 2009 |
| Last Updated: | January 20, 2010 |
| ClinicalTrials.gov Identifier: | NCT00818519 History of Changes |
| Health Authority: | China: State Food and Drug Administration (SFDA) |
|
Moderate Acne Vulgaris Oral contraceptive Female |
|
Estrogens Facial Dermatoses Skin Diseases Contraceptive Agents Hormone Antagonists Contraceptives, Oral Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Ethinyl Estradiol |
Sebaceous Gland Diseases Reproductive Control Agents Hormones Pharmacologic Actions Acne Vulgaris Contraceptives, Oral, Combined Aldosterone Antagonists Acneiform Eruptions Therapeutic Uses Drospirenone |