A Drug Interaction Study of Folic Acid and Oral Contraceptive Tablets Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) in Healthy Women.

NCT00709332 | Completed Phase 1

• 1 other identifier: CR002206
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Drug Interactions; Contraception; Pharmacokinetics

Keywords

Norgestimate; Folic Acid; Ortho-Cyclen; Female contraception; Ethinyl Estradiol; Drug Interactions; Pharmacokinetics; Contraceptives, Oral

Outcome Measures

Primary Outcomes (1)

• Evaluate the pharmacokinetic drug interaction between folic acid and OC (250 mcg NGM and 35 mcg EE) as measured by the pharmacokinetics of the active breakdown products of NGM, (norelgestromin [NGMN], and norgestrel [NG]) and EE.

Secondary Outcomes (1)

• Safety is also assessed.

Interventions

Norgestimate; Ethinyl Estradiol; Folic acid DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Links

• A drug interaction study of folic acid and oral contraceptive tablets containing norgestimate (250 mcg)/ethinyl estradiol (35 mcg) in healthy women

MeSH Terms

Interventions

norgestimate; Ethinyl Estradiol; Folic Acid

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 30, 2008
• First Posted: July 3, 2008
• Study Start: January 1, 2005
• Study Completion: February 1, 2005
• Last Updated: June 8, 2011

Record last verified: 2010-04