Bioequivalence Study of the Oral Contraceptive (OC) Tablet Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) With or Without Folic Acid in Healthy Women.
A Pivotal Bioequivalence Study of 250 Mcg NGM/25 Mcg EE With or Without Folic Acid in Healthy Female Subjects
1 other identifier
interventional
54
0 countries
N/A
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 folic acid. The pharmacokinetics of blood folate from the formulation of 250 mcg NGM/25 mcg EE containing 400 mcg folic acid and from 400 mcg folic acid administered alone is characterized.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2005
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 1, 2008
CompletedFirst Posted
Study publicly available on registry
July 3, 2008
CompletedJune 8, 2011
March 1, 2010
July 1, 2008
June 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the bioequivalence of NGM (as measured by the pharmacokinetics of its active breakdown product NGMN) and EE in 2 formulations of 250 mcg NGM/25 mcg EE, 1 without folic acid and 1 containing 400 mcg folic acid.
Secondary Outcomes (1)
Determine the pharmacokinetics of NG in these 2 formulations; and to characterize the pharmacokinetics of plasma folate after the administration of folic acid alone or in combination with 250 mcg NGM/25 mcg EE. Safety also was assessed.
Interventions
Eligibility Criteria
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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 1, 2008
First Posted
July 3, 2008
Study Start
April 1, 2005
Study Completion
August 1, 2005
Last Updated
June 8, 2011
Record last verified: 2010-03