A Study to Evaluate Folate Levels in Women Taking Oral Contraceptives

September 19, 2016 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Anticipated)

December 1, 2004

Study Registration Dates

First Submitted

March 10, 2006

First Submitted That Met QC Criteria

March 10, 2006

First Posted (Estimate)

March 13, 2006

Study Record Updates

Last Update Posted (Estimate)

September 20, 2016

Last Update Submitted That Met QC Criteria

September 19, 2016

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR002377

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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