Status:
COMPLETED
A Drug Interaction Study of Folic Acid and Oral Contraceptive Tablets Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) in Healthy Women.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Drug Interactions
Contraception
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to assess the effect of folic acid administration on the blood level and the breakdown products of oral contraceptive (OC) \[250 mcg NGM/35 mcg EE\] tablets.
Detailed Description
This is an open-label, randomized (study drug assigned by chance), single-center, pharmacokinetic interaction study. Healthy adult women who met the prestudy eligibility criteria were randomized to 1 ...
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 30 days before study admission
- Used a steroid hormone-containing intrauterine device within 3 months prior to 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 :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2005
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00709332
Start Date
January 1 2005
End Date
February 1 2005
Last Update
June 8 2011
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