Efficacy and Safety Study for an Oral Contraceptive Containing Folate

April 4, 2014 updated by: Bayer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acronym is used in result section: suspected/diagnosed (susp/diag)

Study Type

Interventional

Enrollment (Actual)

385

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Orange County Clinical Trials
      • San Diego, California, United States, 92108
        • Medical Center for Clinical Research
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • SNBL Clinical Pharmacology Center, Inc.
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
    • North Carolina
      • Morrisville, North Carolina, United States, 27560
        • AAIPharma, Inc.
      • Winston-Salem, North Carolina, United States, 27103
        • Lyndhurst Gynecologic Associates
    • South Carolina
      • Mt. Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • New Orleans Center for Clinical Research
    • Washington
      • Tacoma, Washington, United States, 98418
        • Northwest Kinetics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)
1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
Drug: Drospirenone/Ethinylestradiol/Methyltetrahydrofolate
0.020 mg ethinylestradiol with 3.0 mg drospirenone and 0.451 mg L-5-methyltetrahydrofolate (L-5-MTHF)
Active Comparator: Drospirenone (DRSP)/Ethinylestradiol (EE)
1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
Drug: Drospirenone/Ethinylestradiol (Yaz)
0.020 mg ethinylestradiol with 3.0 mg drospirenone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Red Blood Cell (RBC) Folate Level at 24 Weeks
Time Frame: Week 24
RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
Week 24
Plasma Folate Level at 24 Weeks
Time Frame: Week 24
Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Neural Tube Defect (NTD) Risk Reduction at Week 24
Time Frame: Baseline and week 24
The mean NTD risk reduction evaluated as the change from Baseline to Week 24 in NTD risk based on the formula of Daly et al (J Amer Med Assoc 1995;274(21):1698-702); NTD risk=exp (1.6463-1.2193 x natural log [RBC folate]) where natural log [RBC folate] is the natural log of RBC folate measured in nmol/L; Change from Baseline to Week 24 in NTD risk=NTD risk at Week 24 - NTD risk at Baseline
Baseline and week 24
Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 4
Time Frame: baseline and up to week 4
RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
baseline and up to week 4
Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 8
Time Frame: baseline and up to week 8
RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
baseline and up to week 8
Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 12
Time Frame: baseline and up to week 12
RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
baseline and up to week 12
Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 16
Time Frame: baseline and up to week 16
RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
baseline and up to week 16
Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 20
Time Frame: baseline and up to week 20
RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
baseline and up to week 20
Mean Change From Baseline in Plasma Folate Levels at Week 4
Time Frame: baseline and up to week 4
Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
baseline and up to week 4
Mean Change From Baseline in Plasma Folate Levels at Week 8
Time Frame: baseline and up to week 8
Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
baseline and up to week 8
Mean Change From Baseline in Plasma Folate Levels at Week 12
Time Frame: baseline and up to week 12
Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
baseline and up to week 12
Mean Change From Baseline in Plasma Folate Levels at Week 16
Time Frame: baseline and up to week 16
Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
baseline and up to week 16
Mean Change From Baseline in Plasma Folate Levels at Week 20
Time Frame: baseline and up to week 20
Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
baseline and up to week 20
Mean Change From Baseline in Plasma Homocysteine Levels at Week 4
Time Frame: baseline and up to week 4
Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.
baseline and up to week 4
Mean Change From Baseline in Plasma Homocysteine Levels at Week 8
Time Frame: baseline and up to week 8
Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.
baseline and up to week 8
Mean Change From Baseline in Plasma Homocysteine Levels at Week 12
Time Frame: baseline and up to week 12
Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.
baseline and up to week 12
Mean Change From Baseline in Plasma Homocysteine Levels at Week 16
Time Frame: baseline and up to week 16
Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.
baseline and up to week 16
Mean Change From Baseline in Plasma Homocysteine Levels at Week 20
Time Frame: baseline and up to week 20
Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.
baseline and up to week 20
Mean Change From Baseline in Plasma Homocysteine Levels at Week 24
Time Frame: baseline and up to week 24
Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.
baseline and up to week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

April 30, 2007

First Submitted That Met QC Criteria

May 1, 2007

First Posted (Estimate)

May 2, 2007

Study Record Updates

Last Update Posted (Estimate)

April 23, 2014

Last Update Submitted That Met QC Criteria

April 4, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91523
  • 310662 (Other Identifier: Company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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