Trial Condition(s):

Acne vulgaris

Evaluate Safety and Efficacy of an OC Preparation vs placebo for 6 Treatment Cycles in Women with Moderate Acne.

Bayer Identifier:

91209

ClinicalTrials.gov Identifier:

NCT00651469

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The objectives of this study were to evaluate the efficacy and safety of drospirenone 3 mg/ethinyl estradiol 0.02 mg (DRSP/EE) in comparison with placebo in female subjects with moderate acne vulgaris during 6 treatment cycles.

Inclusion Criteria
- Female age 14-45, with 10 to 100 comedones (noninflammatory lesions), 10 to 50 inflammatory lesions (papules or pustules), and not more than 35 nodules (<5mm) on the face).
Exclusion Criteria
- Standard contraindications for use of combined oral contraceptives (class label)
plus
- Subjects with acne and atopia, comedonal acne or acne conglobate, sandpaper acne or acne with multiple large nodes, cysts, fistular comedones, or abscessing fistular ducts
- Use of comedogenic covering cream, comedogenic sunscreens, other sex hormone preparations or any other anti-acne therapy (eg, light therapy, oleic acids, chemical pellings, mechanical extraction of comedones)
- Acne therapy with sex hormone preparations given over 3 months or longer and proved to be unsuccessful 
- Preparations that have had an acne-inducing effect, eg, iodinated or bromated drugs, tuberculostatics, lithium, Vitamin B1, B6, B12, D3, corticoids, ACTH, anabolics, quinine, disulfiram, methoxypsoralen, phenobarbital, phenytoin, trimethadione, thyroid depressants, and certain oily cosmetics

Trial Summary

Enrollment Goal
534
Trial Dates
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Phase
3
Could I receive a placebo?
Yes
Products
YAZ (EE20/DRSP, BAY86-5300)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Radiant Research - Birmingham

Birmingham, United States, 35209

Status
Completed
 
Locations

nTouch Research

Houston, United States, 77024

Status
Completed
 
Locations

Medical Center for Clinical Research

San Diego, United States, 92108

Status
Completed
 
Locations

Piedmont Medical Research Associates Inc.

Winston-Salem, United States, 27103

Status
Completed
 
Locations

Washington Hospital Center

Washington, United States, 20010-2975

Status
Completed
 
Locations

Desert Clinical Research

Mesa, United States, 85201

Status
Completed
 
Locations

Penn State Milton S. Hershey Medical Center

Hershey, United States, 17033-0850

Status
Completed
 
Locations

Academic Dermatology Associates

Albuquerque, United States, 87106

Status
Completed
 
Locations

FXM Research

Miami, United States, 33175

Status
Completed
 
Locations

Boston Clinical Research Center

Wellesley, United States, 02481

Status
Terminated
 
Locations

Impact Clinical Trials

Los Angeles, United States, 90010

Status
Completed
 
Locations

Medical Affiliated Research Center

Huntsville, United States, 35801

Status
Completed
 
Locations

Texas Dermatology Research Institute

Dallas, United States, 75230

Status
Completed
 
Locations

Dermatology Clinical Research Center

San Antonio, United States, 78229

Status
Completed
 
Locations

Wake Forest University School of Medicine

Winston-Salem, United States, 27157

Status
Completed
 
Locations

Omega Medical Research

Warwick, United States, 02886

Status
Completed
 
Locations

DermResearch, Inc.

Austin, United States, 78759

Status
Completed
 
Locations

Dermatology Research Associates, Inc.

Cincinnati, United States, 45230

Status
Completed
 
Locations

Compliant Clinical Research Inc.

Kansas City, United States, 64114

Status
Completed
 
Locations

Comprehensive NeuroScience, Inc.

St. Petersburg, United States, 33702

Status
Completed
 
Locations

Advanced Clinical Research

Boise, United States, 83704

Status
Completed
 
Locations

nTouch Research

Houston, United States, 77024

Status
Terminated
 
Locations

Philadelphia Clinical Research

Philadelphia, United States, 19114

Status
Completed
 
Locations

Insignia Care for Women, P.A.

Tampa, United States, 33607

Status
Completed
 
Locations

Women's Center for Clinical Research

New Orleans, United States, 70115

Status
Completed
 
Locations

Physicians Research Group

Indianapolis, United States, 46250

Status
Completed
 
Locations

Dr. John Lenihan, MD

Tacoma, United States, 98405

Status
Completed
 
Locations

Peryam & Kroll Healthcare Research

Chicago, United States, 60631

Status
Terminated
 

Trial Design