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Efficacy and Safety Study for an Oral Contraceptive Containing Folate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00468481
First received: April 30, 2007
Last updated: April 4, 2014
Last verified: April 2014
  Purpose
The purpose of this study is to determine whether the study drug is safe and effective

Condition Intervention Phase
Neural Tube Defects
Contraception
Oral Contraceptives (OC)
Drug: Drospirenone/Ethinylestradiol/Methyltetrahydrofolate
Drug: Drospirenone/Ethinylestradiol (Yaz)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Red Blood Cell (RBC) Folate Level at 24 Weeks [ Time Frame: Week 24 ]
    RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit

  • Plasma Folate Level at 24 Weeks [ Time Frame: Week 24 ]
    Folate concentrations in plasma were determined by an appropriately validated microbiological assay.


Secondary Outcome Measures:
  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 385
Study Start Date: April 2007
Study Completion Date: September 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468481

Locations
United States, California
Orange County Clinical Trials
Anaheim, California, United States, 92801
Medical Center for Clinical Research
San Diego, California, United States, 92108
United States, Maryland
SNBL Clinical Pharmacology Center, Inc.
Baltimore, Maryland, United States, 21201
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
AAIPharma, Inc.
Morrisville, North Carolina, United States, 27560
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, United States, 27103
United States, South Carolina
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States, 29464
United States, Tennessee
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States, 37920
United States, Washington
NorthWest Kinetics
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00468481     History of Changes
Other Study ID Numbers: 91523
310662 ( Other Identifier: Company internal )
Study First Received: April 30, 2007
Results First Received: January 4, 2011
Last Updated: April 4, 2014

Keywords provided by Bayer:
Healthy women requesting contraception
Folic Acid

Additional relevant MeSH terms:
Neural Tube Defects
Spinal Dysraphism
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities
Drospirenone
Ethinyl Estradiol
Folic Acid
Drospirenone and ethinyl estradiol combination
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Estrogens
Hormones
Hematinics
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Reproductive Control Agents

ClinicalTrials.gov processed this record on April 28, 2017