search
Back to results

A Study to Evaluate Folate Levels in Women Taking Oral Contraceptives

Primary Purpose

Neural Tube Defects, Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Nervous System Malformations

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Norgestimate-ethinyl estradiol, with or without folic acid
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neural Tube Defects focused on measuring spina bifida, birth defects, folic acid, nervous system diseases, folate, Vitamin B

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Non-pregnant post menarcheal, premenopausal females who agree to use the assigned study medication as contraception during the study Non-vegan Non-smoker or no history of tobacco use within 6 months Willing to follow protocol-specific prohibitions and restrictions regarding diet, smoking and use of other medications Exclusion Criteria: Have taken multivitamins, folic-acid containing supplements, or highly fortified (i.e., >200 mcg folic acid/serving) cereals within 30 days of entry in to the study history or presence of blood clots in the veins, strokes or other blood clotting disorder, liver tumor from pervious contraceptive or estrogen use, disease of the blood vessels of the brain or heart disease, uncontrolled high blood pressure, cancer in any part of the body, diabetes mellitus with complications in the flow of blood in the body, jaundice, visual disturbance, liver disease, undiagnosed vaginal bleeding, gastric bypass surgery, ulcerative colitis or other digestive system disorders, abnormal thyroid function, Vitamin B 12 deficiency or very high red blood cell folate levels, alcohol or substance abuse, positive for drugs of abuse recent use of hormonal contraceptives on any weight reduction diet blood donation within 30 days of study entry

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Part 1: Change in concentration of folate in red blood cells (RBC) from the start of the study to Cycle 4 (4 cycles of 28 days of treatment)

    Secondary Outcome Measures

    Change in plasma folate concentration from baseline to Cycle 4; Levels and change from baseline in RBC and plasma folate concentration at specified time points during the study including Cycles 1, 2, 4, 5, 6, 8

    Full Information

    First Posted
    March 10, 2006
    Last Updated
    September 19, 2016
    Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00301587
    Brief Title
    A Study to Evaluate Folate Levels in Women Taking Oral Contraceptives
    Official Title
    A Randomized, Double-Blind, Two-Part, Parallel-Group, Comparative Study to Evaluate Blood Folate Levels in Women Taking an Oral Contraceptive With and Without Folic Acid
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2011
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Company decision to not fund further development of women's health new drug development programs.
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2004 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to compare red blood cell folate levels in women who are taking oral contraceptives with or without folic acid
    Detailed Description
    Studies have shown an association between increased folic acid (a synthetic form of folate, a B-vitamin) intake and reduction of a birth defect referred to as neural tube defects (NTDs). If women using contraception were to receive a combination of an oral contraceptive and folic acid, they may have the benefit of increased blood folate levels, which could reduce the risk of NTDs. This is a multi-center, double-blind study designed to study red blood cell folate levels in women who are taking oral contraceptives with or without folic acid. Patients will receive oral contraceptives with or without folic acid for 8 cycles of 28 days each. The study will consist of 2 parts of 4 cycles each. All patients will receive oral contraceptives throughout both parts of the study, patients may or may not receive folic acid in combination with the oral contraceptive during 1 or both parts of the study. The concentration of red blood cell folate will be determined by laboratory tests after Cycles 1, 2, 4, 5, 6 and 8. Safety evaluations (incidence of adverse events, electrocardiograms, physical examinations, laboratory tests) will be performed throughout the study. Patients may also participate in an optional portion of the study in which their genetic material is analyzed to see if contains something that would affect the way folic acid is used by their bodies. The study hypothesis is that women taking an oral contraceptive with folic acid will have increased levels of red blood cell folate compared to women taking an oral contraceptive without folic acid. Some women who receive the oral contraceptive with folic acid during the first four cycles will be transitioned to an oral contraceptive without folic acid for Cycles 5-8. In this group of women, the rate of decrease in red blood cell folate levels will be measured. Norgestimate 250 micrograms (mcg)-ethinyl estradiol 35 mcg tablets, with or without folic acid 400 mcg, 2 tablets taken by mouth daily between 6:00 a.m. and 10:00 a.m. for 8 cycles of 28 days duration each for a total of 224 days

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neural Tube Defects, Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Nervous System Malformations
    Keywords
    spina bifida, birth defects, folic acid, nervous system diseases, folate, Vitamin B

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Norgestimate-ethinyl estradiol, with or without folic acid
    Primary Outcome Measure Information:
    Title
    Part 1: Change in concentration of folate in red blood cells (RBC) from the start of the study to Cycle 4 (4 cycles of 28 days of treatment)
    Secondary Outcome Measure Information:
    Title
    Change in plasma folate concentration from baseline to Cycle 4; Levels and change from baseline in RBC and plasma folate concentration at specified time points during the study including Cycles 1, 2, 4, 5, 6, 8

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Non-pregnant post menarcheal, premenopausal females who agree to use the assigned study medication as contraception during the study Non-vegan Non-smoker or no history of tobacco use within 6 months Willing to follow protocol-specific prohibitions and restrictions regarding diet, smoking and use of other medications Exclusion Criteria: Have taken multivitamins, folic-acid containing supplements, or highly fortified (i.e., >200 mcg folic acid/serving) cereals within 30 days of entry in to the study history or presence of blood clots in the veins, strokes or other blood clotting disorder, liver tumor from pervious contraceptive or estrogen use, disease of the blood vessels of the brain or heart disease, uncontrolled high blood pressure, cancer in any part of the body, diabetes mellitus with complications in the flow of blood in the body, jaundice, visual disturbance, liver disease, undiagnosed vaginal bleeding, gastric bypass surgery, ulcerative colitis or other digestive system disorders, abnormal thyroid function, Vitamin B 12 deficiency or very high red blood cell folate levels, alcohol or substance abuse, positive for drugs of abuse recent use of hormonal contraceptives on any weight reduction diet blood donation within 30 days of study entry
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
    Organizational Affiliation
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Study to Evaluate Folate Levels in Women Taking Oral Contraceptives

    We'll reach out to this number within 24 hrs