Trial Condition(s):

Acne vulgaris

Evaluate Safety and Efficacy of an Oral Contraceptive (OC) Preparation versus Placebo for 6 Treatment Cycles in Women with Moderate Acne

Bayer Identifier:

91231

ClinicalTrials.gov Identifier:

NCT00656981

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 peelings, 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
541
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
YAZ (EE20/DRSP, BAY86-5300)
Accepts Healthy Volunteers
Yes

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Visions Clinical Research

Palm Springs, United States, 33461

Status
Completed
 
Locations

Stony Brook Dermatology Assoc.

East Steauket, United States, 11733

Status
Completed
 
Locations

Comprehensive NeuroScience, Inc.

St. Petersburg, United States, 33702

Status
Completed
 
Locations

Cherry Creek Research, Inc.

Denver, United States, 80246

Status
Completed
 
Locations

Oregon Medical Research Center

Portland, United States, 97223-6683

Status
Completed
 
Locations

Westlake Medical Research

Westlake Village, United States, 91361

Status
Completed
 
Locations

Compliant Clinical Research, Inc.

Shawnee, United States, 66203

Status
Completed
 
Locations

Dr. T. Joseph Raoof, M.D. Inc.

Encino, United States, 91436

Status
Completed
 
Locations

Women's Health Care, Inc.

San Diego, United States, 92123

Status
Completed
 
Locations

Sloane Hospital for Women

New York, United States, 10022

Status
Completed
 
Locations

Clinical Trial Center of Colorado

Castle Rock, United States, 80108

Status
Completed
 
Locations

Women's Clinical Research Center

Seattle, United States, 98105

Status
Completed
 
Locations

Genesis Center for Clinical Research

San Diego, United States, 92103

Status
Completed
 
Locations

OB/GYN Health Center

Medford, United States, 97504

Status
Completed
 
Locations

Arizona Desert Dermatology

Kingman, United States, 86401

Status
Completed
 
Locations

Advanced Clinical Research

Boise, United States, 83704

Status
Completed
 
Locations

J & S Studies, Inc.

Byran, United States, 77801

Status
Completed
 
Locations

Minnesota Clinical Study Center

Fridley, United States, 55432

Status
Completed
 
Locations

Millennium Clinical Research Center

Arlington, United States, 22203

Status
Completed
 
Locations

Coastal Clinical Research, Inc

Mobile, United States, 36608

Status
Completed
 
Locations

Dr. Robert Semo, MD

Venice, United States, 34285

Status
Completed
 
Locations

Physician's Skin Care

Louisville, United States, 40217

Status
Completed
 

Trial Design