Efficacy and Safety Study for an Oral Contraceptive Containing Folate

PHASE3CompletedINTERVENTIONAL
Enrollment

385

Participants

Timeline

Start Date

April 30, 2007

Primary Completion Date

August 31, 2008

Study Completion Date

September 30, 2008

Conditions
Neural Tube DefectsContraceptionOral Contraceptives (OC)
Interventions
DRUG

Drospirenone/Ethinylestradiol/Methyltetrahydrofolate

0.020 mg ethinylestradiol with 3.0 mg drospirenone and 0.451 mg L-5-methyltetrahydrofolate (L-5-MTHF)

DRUG

Drospirenone/Ethinylestradiol (Yaz)

0.020 mg ethinylestradiol with 3.0 mg drospirenone

Trial Locations (9)

10032

Columbia University Medical Center, New York

21201

SNBL Clinical Pharmacology Center, Inc., Baltimore

27103

Lyndhurst Gynecologic Associates, Winston-Salem

27560

AAIPharma, Inc., Morrisville

29464

Coastal Carolina Research Center, Mt. Pleasant

37920

New Orleans Center for Clinical Research, Knoxville

92108

Medical Center for Clinical Research, San Diego

92801

Orange County Clinical Trials, Anaheim

98418

NorthWest Kinetics, Tacoma

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY