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Estradiol/Norethindrone

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Dec 17, 2010

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment76
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01157182Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fasting ConditionsPHASE1 COMPLETED 36 — — Feb 1, 2007Apr 1, 2007Dec 17, 20101 Canada
NCT01181726Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fed ConditionsPHASE1 COMPLETED 40 — — Jan 1, 2007Feb 1, 2007Dec 8, 20101 Canada
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Study Endpoints
Primary Endpoints
Cmax for Norethindrone(Maximum Observed Concentration of Drug Substance in Plasma)
Blood samples collected over a 36 hour period.

Bioequivalence based on Norethindrone Cmax.

AUC0-t for Norethindrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Blood samples collected over a 36 hour period.

Bioequivalence based on Norethindrone AUC0-t.

AUC0-inf for Norethindrone(Area Under the Concentration-time Curve From Time Zero to Infinity)
Blood samples collected over a 36 hour period.

Bioequivalence based on Norethindrone AUC0-inf.

Cmax for Corrected Total Estrone(Maximum Observed Concentration of Drug Substance in Plasma)
Blood samples collected over a 72 hour period.

Bioequivalence based on Corrected Total Estrone Cmax.

AUC0-t for Corrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Blood samples collected over a 72 hour period.

Bioequivalence based on Corrected Total Estrone AUC0-t.

AUC0-inf for Corrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)
Blood samples collected over a 72 hour period.

Bioequivalence based on Corrected Total Estrone AUC0-inf.

Cmax of Norethindrone (Maximum Observed Concentration of Drug Substance in Plasma)
Blood samples collected over a 36 hour period.

Bioequivalence based on Norethindrone Cmax.

AUC0-t of Norethindrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Blood samples collected over a 36 hour period.

Bioequivalence based on Norethindrone AUC0-t.

AUC0-inf of Norethindrone(Area Under the Concentration-time Curve From Time Zero to Infinity)
Blood samples collected over a 36 hour period.

Bioequivalence based on Norethindrone AUC0-inf.

Cmax of Corrected Total Estrone(Maximum Observed Concentration of Drug Substance in Plasma)
Blood samples collected over a 72 hour period.

Bioequivalence based on Corrected Total Estrone Cmax.

AUC0-t of Corrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Blood samples collected over a 72 hour period.

Bioequivalence based on Corrected Total Estrone AUC0-t.

AUC0-inf of Corrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)
Blood samples collected over a 72 hour period.

Bioequivalence based on Corrected Total Estrone AUC0-inf.

Secondary Endpoints
Cmax for Uncorrected Total Estrone(Maximum Observed Concentration of Drug Substance in Plasma)
Blood samples collected over a 72 hour period.
AUC0-t for Uncorrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Blood samples collected over a 72 hour period.
AUC0-inf for Uncorrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)
Blood samples collected over a 72 hour period.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
Investigational Test ProductEXPERIMENTALEstradiol/Norethindrone acetate 1/0.5 mg Tablets
Reference Listed DrugACTIVE_COMPARATORActivella® 1/0.5 mg Tablets
Interventions
NameTypeDescription
Estradiol/Norethindrone acetateDRUG1/0.5 mg Tablets
Activella®DRUG1/0.5 mg Tablets
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Eligibility Criteria
Age Range18 Years — 65 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Non-smoking or smoking (up to 10 cigarettes/day), physiologically or surgically post-menopausal female within the age range of 18-65 years. * 17β-estradiol serum levels of \< 90 pmol/L and follicle-stimulating hormone (FSH) of \> 40 IU/L. * Body Mass Index greater than or equa...

Countries:Canada
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