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

PHASE3CompletedINTERVENTIONAL
Enrollment

534

Participants

Timeline

Start Date

January 31, 2003

Study Completion Date

July 31, 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 (27)

19114

Philadelphia

27103

Winston-Salem

27157

Winston-Salem

33175

Miami

33607

Tampa

33702

St. Petersburg

35209

Birmingham

35801

Huntsville

45230

Cincinnati

46250

Indianapolis

60631

Chicago

64114

Kansas City

70115

New Orleans

75230

Dallas

77024

Houston

78229

San Antonio

78759

Austin

83704

Boise

85201

Mesa

87106

Albuquerque

90010

Los Angeles

92108

San Diego

98405

Tacoma

20010-2975

Washington D.C.

02481

Wellesley

17033-0850

Hershey

02886

Warwick

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT00651469 - Evaluate Safety and Efficacy of an OC Preparation vs Placebo for 6 Treatment Cycles in Women With Moderate Acne. | Biotech Hunter | Biotech Hunter