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Completed Phase 3 Interventional Accepts healthy volunteers Results available

Efficacy and Safety Study for an Oral Contraceptive Containing Folate

ClinicalTrials.gov ID: NCT00468481

Public ClinicalTrials.gov record NCT00468481. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 2:45 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Multi-Center, Randomized, Double-Blind Active-Controlled, Parallel Group Study to Investigate Plasma Folate, Red Blood Cell Folate and Homocysteine Levels During a 24 Week Oral Administration of an OC Containing Folate Compared to OC Alone

Study identification

NCT ID
NCT00468481
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Bayer
Industry
Enrollment
385 participants

Conditions and interventions

Interventions

  • Drospirenone/Ethinylestradiol/Methyltetrahydrofolate Drug
  • Drospirenone/Ethinylestradiol (Yaz) Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 40 Years
Sex
Female
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2007
Primary completion
Jul 31, 2008
Completion
Aug 31, 2008
Last update posted
Apr 22, 2014

2007 – 2008

United States locations

U.S. sites
9
U.S. states
7
U.S. cities
9
Facility City State ZIP Site status
Orange County Clinical Trials Anaheim California 92801
Medical Center for Clinical Research San Diego California 92108
SNBL Clinical Pharmacology Center, Inc. Baltimore Maryland 21201
Columbia University Medical Center New York New York 10032
AAIPharma, Inc. Morrisville North Carolina 27560
Lyndhurst Gynecologic Associates Winston-Salem North Carolina 27103
Coastal Carolina Research Center Mt. Pleasant South Carolina 29464
New Orleans Center for Clinical Research Knoxville Tennessee 37920
NorthWest Kinetics Tacoma Washington 98418

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00468481, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 22, 2014 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00468481 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →