Status:
COMPLETED
Bioequivalence Study of the Oral Contraceptive (OC) Tablet Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) With or Without Folic Acid in Healthy Women.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Pharmacokinetics
Therapeutic Equivalency
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to determine the bioequivalence of Norgestimate (NGM) and Ethinyl Estradiol (EE) in 2 formulations of 250 mcg NGM/25 mcg EE, 1 without folic acid and 1 containing 400 mcg f...
Detailed Description
This is a single-center, open-label, randomized (study drug assigned by chance), 3-way crossover bioequivalence study of a single dose of 250 mcg NGM/25 mcg EE with or without folic acid. The study co...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00709644
Start Date
April 1 2005
End Date
August 1 2005
Last Update
June 8 2011
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