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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

Tracking Information
First Submitted Date  ICMJE April 30, 2007
First Posted Date  ICMJE May 2, 2007
Results First Submitted Date  ICMJE January 4, 2011
Results First Posted Date  ICMJE January 25, 2011
Last Update Posted Date April 23, 2014
Study Start Date  ICMJE April 2007
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2011)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 1, 2007)
The red blood cell folate level at Week 24 (Cycle 6)
Change History Complete list of historical versions of study NCT00468481 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2011)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2007)
• The neural tube defect risk reduction based on Daly et al formula
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study for an Oral Contraceptive Containing Folate
Official Title  ICMJE 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
Brief Summary The purpose of this study is to determine whether the study drug is safe and effective
Detailed Description Acronym is used in result section: suspected/diagnosed (susp/diag)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Neural Tube Defects
  • Contraception
  • Oral Contraceptives (OC)
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: Drospirenone/Ethinylestradiol/Methyltetrahydrofolate
  • 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
    Intervention: Drug: Drospirenone/Ethinylestradiol (Yaz)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 1, 2008)
385
Original Estimated Enrollment  ICMJE
 (submitted: May 1, 2007)
344
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00468481
Other Study ID Numbers  ICMJE 91523
310662 ( Other Identifier: Company internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP