Trial Condition(s):

Neural Tube Defects, Contraception, Oral Contraceptives (OC)

Efficacy and Safety Study for an Oral Contraceptive Containing Folate

Bayer Identifier:

91523

ClinicalTrials.gov Identifier:

NCT00468481

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The purpose of this study is to determine whether the study drug is safe and effective

Inclusion Criteria
- Healthy women between 18 and 40 requesting oral contraception
Exclusion Criteria
- The use of steroidal oral contraceptives, or any drug that could alter Oral Contraception metabolism will be prohibited during the study

Trial Summary

Enrollment Goal
385
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
EE/DRSP/L-5-MTHF (BAY86-5131)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Orange County Clinical Trials

Anaheim, United States, 92801

Status
Completed
 
Locations

Medical Center for Clinical Research

San Diego, United States, 92108

Status
Completed
 
Locations

SNBL Clinical Pharmacology Center, Inc.

Baltimore, United States, 21201

Status
Completed
 
Locations

AAIPharma, Inc.

Morrisville, United States, 27560

Status
Completed
 
Locations

Coastal Carolina Research Center

Mt. Pleasant, United States, 29464

Status
Completed
 
Locations

NorthWest Kinetics

Tacoma, United States, 98418

Status
Completed
 
Locations

New Orleans Center for Clinical Research

Knoxville, United States, 37920

Status
Completed
 
Locations

Columbia University Medical Center

New York, United States, 10032

Status
Completed
 
Locations

Lyndhurst Gynecologic Associates

Winston-Salem, United States, 27103

Status
Completed
 

Trial Design