A Drug Interaction Study of Folic Acid and Oral Contraceptive Tablets Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) in Healthy Women.

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of the study is to assess the effect of folic acid administration on the blood level and the breakdown products of oral contraceptive (OC) [250 mcg NGM/35 mcg EE] tablets.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Contraceptive Agents; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Folic Acid; Norgestimate; Norgestrel; Polyestradiol phosphate; Vitamin B Complex

Criteria

Inclusion Criteria:

• Healthy

• Nonpregnant

• Nonlactating

• Nonsmoking women

• Weighing at least 110 pounds

• With regular menstrual cycles

• A body mass index between 16 and 29.9 kg/m2

• And a hematocrit of at least 36%

Exclusion Criteria:

• History or presence of disorders commonly accepted as contraindications to sex hormonal therapy including: thromboembolic disorders cerebral vascular or coronary artery disease, chronic untreated hypertension, or migraines, benign or malignant liver tumor that developed during the use of OC

• Known or suspected estrogen-dependent neoplasia

• Presence of disorders commonly accepted as contraindications to combined OC including:

undiagnosed abnormal vaginal bleeding, any neurovascular lesion of the eye or serious visual disturbance, or liver disease

• Intake any multivitamin or folic acid-containing supplements within 30 days before study admission

• Used a steroid hormone-containing intrauterine device within 3 months prior to study admission

• Used any medications that were known cytochrome P-450 enzyme inducers or inhibitors (e.g., St. John's Wort, cimetidine or rifampin), within 60 days before dosing.