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
Healthy
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 OC study drug (250 mcg norgestimate\[NGM\]/35 mcg Ethinyl Estradiol \[EE\...
Detailed Description
This is a single-center, open-label, pharmacokinetic drug interaction study between folic acid (1 mg) and study drug (250 mcg NGM/35 mcg EE) in 2 groups of at least 20 healthy women each. In Group 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 having 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 :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00709982
Start Date
May 1 2005
End Date
July 1 2005
Last Update
June 8 2011
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