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GA YAZ ACNE in China Phase III
This study is ongoing, but not recruiting participants.
First Received: January 6, 2009   Last Updated: January 20, 2010   History of Changes
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

Resource links provided by NLM:

MedlinePlus related topics: Acne
Drug Information available for: Ethinyl estradiol 1,2-Dihydrospirorenone
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00818519

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
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site
Click here to find results for studies related to marketed products  This link exits the ClinicalTrials.gov site

No publications provided

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)

Keywords provided by Bayer:
Moderate Acne Vulgaris
Oral contraceptive
Female

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 08, 2010



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