A Study to Evaluate Folate Levels in Women Taking Oral Contraceptives

• Status: Withdrawn
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Contraceptive Agents; Contraceptives, Oral; Estradiol; Ethinyl Estradiol; Fluoroquinolones; Folic Acid; Moxifloxacin; Norgestimate; Norgestimate, ethinyl estradiol drug combination; Vitamin B Complex

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