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Norgestimate; Ethinyl Estradiol; Folic acid

Phase 1

Drug Interactions | Small molecule | Other |Johnson & Johnson|Last Updated: Jun 8, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment94
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00709982A Drug Interaction Study of Folic Acid and Oral Contraceptive Tablets Containing Norgestimate (NGM) /Ethinyl Estradiol (EE) in Healthy Women.PHASE1 COMPLETED 47 — — May 1, 2005Jul 1, 2005Jun 8, 2011 - —
NCT00709332A Drug Interaction Study of Folic Acid and Oral Contraceptive Tablets Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) in Healthy Women.PHASE1 COMPLETED 47 — — Jan 1, 2005Feb 1, 2005Jun 8, 2011 - —
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Study Endpoints
Primary Endpoints
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.
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 Endpoints
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.
Safety is also assessed.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
Norgestimate; Ethinyl Estradiol; Folic acidDRUG -
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Eligibility Criteria
Age Range18 Years — 45 Years
SexFEMALE
Healthy VolunteersYes

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...

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