Clinical Trial: Efficacy and Safety Study for an Oral Contraceptive Containing Folate

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary: Acronym is used in result section: suspected/diagnosed (susp/diag)
Sponsor: Bayer

Current Primary Outcome:

• 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: The red blood cell folate level at Week 24 (Cycle 6)

Current Secondary Outcome:

• 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: • The neural tube defect risk reduction based on Daly et al formula

Information By: Bayer

Dates:
Date Received: April 30, 2007
Date Started: April 2007
Date Completion:
Last Updated: April 4, 2014
Last Verified: April 2014