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Asoprisnil/Premarin

Phase 2

Amenorrhea | Small molecule | Other |Abbott Laboratories|Last Updated: May 29, 2008

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment105
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00152282A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal WomenPHASE2 COMPLETED 105 — — Sep 1, 2000Aug 1, 2001May 29, 2008 - —
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Study Endpoints
Primary Endpoints
Assessment of endometrium by endometrial biopsy
Week 12
Change from baseline in endometrial thickness as assessed by ultrasound
Week 12
Secondary Endpoints
Frequency and amount of vaginal bleeding via patient diary.
Week 4, 8, and 12
Incidence of hot flushes
Week 4, 8, and 12
Presence or absence of endometrial hyperplasia.
Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -
4PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Asoprisnil/PremarinDRUGAsoprisnil 5mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
Placebo and PremarinDRUGPlacebo and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
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Eligibility Criteria
Age Range48 Years — 65 Years
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Postmenopausal women with an intact uterus * Body mass index (BMI) between 18.0 - 33.0 * Good general health * Endometrial thickness ≤ 4 mm by TVU * No history or suspected endometrial hyperplasia * Negative urine pregnancy test * Pap smear in last 6 months with no evidence of...

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