Efficacy and Safety Study for an Oral Contraceptive Containing Folate

Phase 3CompletedNCT00468481

Bayer385 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

385

Conditions

Neural Tube Defects Contraception Oral Contraceptives (OC)

Interventions

Drospirenone/Ethinylestradiol/MethyltetrahydrofolateDRUG

0.020 mg ethinylestradiol with 3.0 mg drospirenone and 0.451 mg L-5-methyltetrahydrofolate (L-5-MTHF)

Drospirenone/Ethinylestradiol (Yaz)DRUG

0.020 mg ethinylestradiol with 3.0 mg drospirenone

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (9)

Orange County Clinical Trials

Anaheim, California, United States

Medical Center for Clinical Research

San Diego, California, United States

SNBL Clinical Pharmacology Center, Inc.

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Red Blood Cell (RBC) Folate Level at 24 Weeks

RBC folate=(\[whole blood folate\*100\]-\[plasma folate\*(100-hematocrit)\])/hematocrit

Time frame: Week 24

Plasma Folate Level at 24 Weeks

Folate concentrations in plasma were determined by an appropriately validated microbiological assay.

Time frame: Week 24

Secondary Outcomes

Mean Neural Tube Defect (NTD) Risk Reduction at 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

Time frame: Baseline and week 24

Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 4

RBC folate=(\[whole blood folate\*100\]-\[plasma folate\*(100-hematocrit)\])/hematocrit

Time frame: baseline and up to week 4

Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 8

RBC folate=(\[whole blood folate\*100\]-\[plasma folate\*(100-hematocrit)\])/hematocrit

Time frame: baseline and up to week 8

Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 12

RBC folate=(\[whole blood folate\*100\]-\[plasma folate\*(100-hematocrit)\])/hematocrit

Time frame: baseline and up to week 12

Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 16

Data from ClinicalTrials.gov

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Columbia University Medical Center

New York, New York, United States

AAIPharma, Inc.

Morrisville, North Carolina, United States

Lyndhurst Gynecologic Associates

Winston-Salem, North Carolina, United States

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, United States

New Orleans Center for Clinical Research

Knoxville, Tennessee, United States

NorthWest Kinetics

Tacoma, Washington, United States

RBC folate=(\[whole blood folate\*100\]-\[plasma folate\*(100-hematocrit)\])/hematocrit

Time frame: baseline and up to week 16

Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 20

RBC folate=(\[whole blood folate\*100\]-\[plasma folate\*(100-hematocrit)\])/hematocrit

Time frame: baseline and up to week 20

Mean Change From Baseline in Plasma Folate Levels at Week 4

Folate concentrations in plasma were determined by an appropriately validated microbiological assay.

Time frame: baseline and up to week 4

Mean Change From Baseline in Plasma Folate Levels at Week 8

Folate concentrations in plasma were determined by an appropriately validated microbiological assay.

Time frame: baseline and up to week 8

Mean Change From Baseline in Plasma Folate Levels at Week 12

Folate concentrations in plasma were determined by an appropriately validated microbiological assay.

Time frame: baseline and up to week 12

Mean Change From Baseline in Plasma Folate Levels at Week 16

Folate concentrations in plasma were determined by an appropriately validated microbiological assay.

Time frame: baseline and up to week 16

Mean Change From Baseline in Plasma Folate Levels at Week 20

Folate concentrations in plasma were determined by an appropriately validated microbiological assay.

Time frame: baseline and up to week 20

Mean Change From Baseline in Plasma Homocysteine Levels at Week 4

Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.

Time frame: baseline and up to week 4

Mean Change From Baseline in Plasma Homocysteine Levels at Week 8

Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.

Time frame: baseline and up to week 8

Mean Change From Baseline in Plasma Homocysteine Levels at Week 12

Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.

Time frame: baseline and up to week 12

Mean Change From Baseline in Plasma Homocysteine Levels at Week 16

Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.

Time frame: baseline and up to week 16

Mean Change From Baseline in Plasma Homocysteine Levels at Week 20

Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.

Time frame: baseline and up to week 20

Mean Change From Baseline in Plasma Homocysteine Levels at Week 24

Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.

Time frame: baseline and up to week 24