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Efficacy and Safety Study for an Oral Contraceptive Containing Folate

NCT00468481 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 385

Last updated 2014-04-23

Study results available
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Summary

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

Conditions

  • Neural Tube Defects
  • Contraception
  • Oral 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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2008-08-31
Completion
2008-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00468481 on ClinicalTrials.gov