A Study to Evaluate Folate Levels in Women Taking Oral Contraceptives

NCT00301587 | Withdrawn Phase 3

• 1 other identifier: CR002377
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

Norgestimate-ethinyl estradiol, with or without folic acid DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

MeSH Terms

Conditions

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

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 10, 2006
• First Posted: March 13, 2006
• Study Completion: December 1, 2004
• Last Updated: September 20, 2016

Record last verified: 2011-07