Overview

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