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Efficacy and Safety Study for an Oral Contraceptive Containing Folate

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ClinicalTrials.gov Identifier: NCT00468481
Recruitment Status : Completed
First Posted : May 2, 2007
Results First Posted : January 25, 2011
Last Update Posted : April 23, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

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

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 385 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : April 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : September 2008


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



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

  2. 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 :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  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.

  17. 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.



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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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications of Results:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00468481     History of Changes
Other Study ID Numbers: 91523
310662 ( Other Identifier: Company internal )
First Posted: May 2, 2007    Key Record Dates
Results First Posted: January 25, 2011
Last Update Posted: April 23, 2014
Last Verified: April 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
Folic Acid
Drospirenone
Ethinyl Estradiol
Drospirenone and ethinyl estradiol combination
Hematinics
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Estrogens
Hormones
Reproductive Control Agents