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

PHASE3CompletedINTERVENTIONAL
Enrollment

541

Participants

Timeline

Start Date

January 31, 2003

Study Completion Date

June 30, 2004

Conditions
Acne Vulgaris
Interventions
DRUG

YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)

The study medication was packaged in 28-tablet blister packs. Each subject kit contained 6 blister packs plus 1 reserve blister pack.Subjects randomly assigned to the active treatment group received 24 consecutive days of hormonally active tablets (3mgDRSP/0.02mgEE) followed by 4 consecutive days of inactive tablets. The treatment period was 6 cycles (28 tablets per cycle).

DRUG

Placebo

The subjects randomly assigned to the placebo group received 28 inert but identical-appearing, color-matched tablets. The treatment period was 6 cycles (28 tablets per cycle)

Trial Locations (22)

10022

New York

11733

East Steauket

22203

Arlington

33461

Palm Springs

33702

St. Petersburg

34285

Venice

36608

Mobile

40217

Louisville

55432

Fridley

66203

Shawnee

77801

Byran

80108

Castle Rock

80246

Denver

83704

Boise

86401

Kingman

91361

Westlake Village

91436

Encino

92103

San Diego

92123

San Diego

97504

Medford

98105

Seattle

97223-6683

Portland

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT00656981 - Evaluate Safety and Efficacy of an Oral Contraceptive (OC) Preparation Versus Placebo for 6 Treatment Cycles in Women With Moderate Acne | Biotech Hunter | Biotech Hunter