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medroxyprogesterone

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Aug 19, 2024

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 Trials1
Total Enrollment124
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00830414Medroxyprogesterone Acetate Injection 150 mg/1 mL in Postmenopausal WomenPHASE1 COMPLETED 124Apr 1, 2002Sep 1, 2002Aug 19, 20241 Germany
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Study Endpoints
Primary Endpoints
Bioequivalence based on Cmax and AUC
120 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATORDEPO-PROVERA®
Interventions
NameTypeDescription
medroxyprogesterone acetateDRUGIM Injection
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Eligibility Criteria
Age Range45 Years — N/A
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria * Screening Demographics: All volunteers selected for this study will be healthy postmenopausal women 45 years of age or older at the time of dosing. The weight range will not exceed ±20% for height and body frame as per Desirable Weights for Women - 1983 Metropolitan Height and ...

Countries:Germany
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