Bioequivalence Study of the Oral Contraceptive Tablet Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) With or Without Folic Acid in Healthy Women.

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of the study is to determine the bioequivalence of NGM and EE in 2 formulations of 250 mcg NGM/35 mcg EE, 1 without folic acid and 1 containing 400 mcg folic acid. The pharmacokinetics of blood folate from the formulation of 250 mcg NGM/35 mcg EE containing 400 mcg folic acid and from 400 mcg folic acid administered alone is characterized.

• 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