Efficacy and Safety Study for an Oral Contraceptive Containing Folate

Phase 3

Completed

• Conditions: Neural Tube Defects; Contraception; Oral Contraceptives (OC)
• Interventions: Drug: Drospirenone/Ethinylestradiol/Methyltetrahydrofolate; Drug: Drospirenone/Ethinylestradiol (Yaz)

• Registration Number: NCT00468481
• Lead Sponsor: Bayer

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 Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-30
• Study First Submitted QC: 2007-05-01
• Study First Posted: 2007-05-02
• Primary Completion: 2008-08
• Study Completion: 2008-09
• Disposition First Submitted: 2009-11-19
• Disposition First Submitted QC: 2009-11-19
• Disposition First Posted: 2009-11-23
• Results First Submitted: 2011-01-04
• Results First Submitted QC: 2011-01-04
• Results First Posted: 2011-01-25
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-04
• Last Update Posted: 2014-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 385

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)	Drospirenone/Ethinylestradiol/Methyltetrahydrofolate	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
Drospirenone (DRSP)/Ethinylestradiol (EE)	Drospirenone/Ethinylestradiol (Yaz)	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 12	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	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	baseline and up to week 20	RBC folate=(\[whole blood folate\*100\]-\[plasma folate\*(100-hematocrit)\])/hematocrit
Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 4	baseline and up to week 4	RBC folate=(\[whole blood folate\*100\]-\[plasma folate\*(100-hematocrit)\])/hematocrit
Mean Change From Baseline in Plasma Folate Levels at Week 8	baseline and up to week 8	Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
Mean Neural Tube Defect (NTD) Risk Reduction at Week 24	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 8	baseline and up to week 8	RBC folate=(\[whole blood folate\*100\]-\[plasma folate\*(100-hematocrit)\])/hematocrit
Mean Change From Baseline in Plasma Folate Levels at Week 4	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 12	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	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	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	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	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	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	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	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	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.

Trial Locations

Locations (9)

NorthWest Kinetics; 🇺🇸 Tacoma, Washington, United States

Lyndhurst Gynecologic Associates; 🇺🇸 Winston-Salem, North Carolina, United States

Orange County Clinical Trials; 🇺🇸 Anaheim, California, United States

Medical Center for Clinical Research; 🇺🇸 San Diego, California, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

New Orleans Center for Clinical Research; 🇺🇸 Knoxville, Tennessee, United States

Coastal Carolina Research Center; 🇺🇸 Mt. Pleasant, South Carolina, United States

AAIPharma, Inc.; 🇺🇸 Morrisville, North Carolina, United States

SNBL Clinical Pharmacology Center, Inc.; 🇺🇸 Baltimore, Maryland, United States