Overview

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