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: 2005-07-01
• 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 OC study drug (250 mcg norgestimate[NGM]/35 mcg Ethinyl Estradiol [EE]) tablets. The effect of study drug tablet intake on the blood level of folic acid is also determined.

• 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 having 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 21 days before study admission

• Used a steroid hormone-containing intrauterine device within 3 months before 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