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Completed

NCT Number: NCT00468481

Efficacy and Safety Study for an Oral Contraceptive Containing Folate

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

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Key information

Conditions

Neural Tube Defects Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Contraception Nervous System Diseases Nervous System Malformations Oral Contraceptives (OC)

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Orange County Clinical Trials, Anaheim, California, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drospirenone/Ethinylestradiol/Methyltetrahydrofolate

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 2, 2007
Registry last updated
Apr 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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