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Asoprisnil

Phase 3

Leiomyoma | Small molecule | Other |Abbott Laboratories|Last Updated: Mar 4, 2009

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_CONTROLLEDDMCBiomarker
Total Trials5
Total Enrollment1,597
FDA Designations
No designations recorded
Clinical Trials (5)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00156195Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine FibroidsPHASE3 COMPLETED 523 — — Sep 1, 2003Jan 1, 2007May 29, 2008 - —
NCT00160381A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine FibroidsPHASE3 COMPLETED 432 — — Sep 1, 2002Jan 1, 2005May 29, 2008 - —
NCT00152269Treatment of Uterine Fibroids With Asoprisnil(J867)PHASE3 COMPLETED 475 — — Jul 1, 2002Jan 1, 2005May 29, 2008 - —
NCT00156182A Long-Term Safety Study of Asoprisnil in the Treatment of Uterine Fibroids.PHASE2 COMPLETED 38 — — Apr 1, 2001Dec 1, 2001Mar 4, 2009 - —
NCT00160459A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine FibroidsPHASE2 COMPLETED 129 — — May 1, 2000Jul 1, 2001May 29, 2008 - —
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Study Endpoints
Primary Endpoints
The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention.
Month 12
The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and who do not require surgical/invasive intervention.
Month 12 or Final Visit
The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not have surgical/invasive intervention.
Month 12 or Final Visit
Percent change from baseline in uterine volume and volume of the largest fibroid from pre-treatment in study M99-144
Treatment months 3 and 6 and Post-treatment months 3 and 6
Percentage of subjects that achieved amenorrhea.
Treatment months 1-6
Percent change from baseline in uterine volume and volume of the largest fibroid.
Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6.
Duration of amenorrhea
Day 1 to 1st post treatment menses
Secondary Endpoints
The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention.
Month 6
Change from baseline in menstrual pictogram bleeding score.
Final Month
Change from baseline in the number of days with bleeding.
Final Month
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3PLACEBO_COMPARATOR -
4PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
AsoprisnilDRUG10 mg Tablet, oral Daily for 12 months
PlaceboDRUGTablet, oral Daily for 12 months
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Women who have completed 12 months of treatment in study M01-390 or study M01-394 and their Visit 12 procedures, respectively * Otherwise in good health * Premenopausal based on Estrogen and FSH levels * Agrees to use of double barrier method of contraception * Adequate endome...

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