Healthy Clinical Trial
Official title:
An Open-label Pharmacokinetic Drug Interaction Study of Folic Acid and 250 Mcg NGM/35 Mcg EE (ORTHO-CYCLEN) in Healthy Women..
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.
Status | Completed |
Enrollment | 47 |
Est. completion date | July 2005 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate the pharmacokinetic drug interaction between folic acid and the study drug (250 mcg NGM and 35 mcg EE) as measured by the pharmacokinetics of the active breakdown product of NGM, norelgestromin (NGMN), and EE. | |||
Secondary | Measure the pharmacokinetics of the active metabolite of NGM, norgestrel (NG). Evaluate the effect of the study drug on the pharmacokinetics of folic acid. Assess the safety. |
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