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Asoprisnil

Phase 3

Fibroid Uterus | Small molecule | Endocrine |Abbott Laboratories|Last Updated: Mar 4, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials3
Total Enrollment554

FDA Designations

No designations recorded

Clinical trial landscape

Asoprisnil · 12 trials · 6 indications

Phase 3 6Phase 2 6
NCT00156156Study of Asoprisnil in the Treatment of Uterine Fibroids.Fibroid Uterus
COMPLETED149 Analytics
NCT00156208Safety of Treatment of Uterine Fibroids With AsoprisnilFibroid Uterus
COMPLETED166 Analytics
NCT00152256A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine FibroidsFibroid Uterus
COMPLETED239 Analytics
NCT00156195Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine FibroidsLeiomyoma
COMPLETED523 Analytics
NCT00160381A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine FibroidsLeiomyoma
COMPLETED432 Analytics
NCT00152269Treatment of Uterine Fibroids With Asoprisnil(J867)Leiomyoma
COMPLETED475 Analytics
PHASE3COMPLETED
Study of Asoprisnil in the Treatment of Uterine Fibroids.
Fibroid Uterus
NCT00156156149
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PHASE3COMPLETED
Safety of Treatment of Uterine Fibroids With Asoprisnil
Fibroid Uterus
NCT00156208166
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PHASE3COMPLETED
A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids
Fibroid Uterus
NCT00152256239
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PHASE3COMPLETED
Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids
Leiomyoma
NCT00156195523
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PHASE3COMPLETED
A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids
Leiomyoma
NCT00160381432
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PHASE3COMPLETED
Treatment of Uterine Fibroids With Asoprisnil(J867)
Leiomyoma
NCT00152269475
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Study Endpoints

Primary Endpoints

Long-term Safety.
Throughout 2 year treatment period
Long Term Safety
Throughout 18 month treatment period
Cumulative percent of subjects achieving amenorrhea.
Month 3
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
Change from baseline to the Final Visit in uterine artery blood flow as determined by change in Resistance Index.
Final visit
Change from baseline in pelvic pain and dysmenorrhea assessed by visual analog scale.
Months 1,3,6,9,12 and final visit
Change from baseline in pelvic pain, dysmenorrhea, dyspareunia, pelvic tenderness and induration assessed by modified Biberoglu and Behrman grading scale.
Months 3,6,9,12 and final visit
Mean change from baseline in pelvic pain as assessed by daily diary
Final month
Mean change from baseline in dysmenorrhea as assessed by daily diary
Final month
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
Pain (dysmenorrhea, dyspareunia, pelvic pain) measured by daily diary
Mean change from baseline to Months 1, 2, 3
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

Change from baseline in the monthly bleeding score and the number of days with bleeding.
Each Month
Change from baseline in hemoglobin, hematocrit, TIBC, ferritin and iron concentrations.
Months 3, 6, 9,12,15,18, 24
Percent change from baseline in volume of the largest fibroid.
Months 12, 24
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3PLACEBO_COMPARATOR -
4PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
AsoprisnilDRUGAsoprisnil 10 mg Tablet, oral Daily for up to 2 years
PlaceboDRUGPlacebo Tablet, oral Daily for 6 months
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Women who have completed 12 months of active treatment in study M01-391 and Month 12 visit procedures Or completed 18 months of active treatment in study C03-062 and Month 18 visit procedures (with no more than a 14-day interruption in dosing from study C02-062 and this study)...

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Frequently asked questions about Asoprisnil

What is Asoprisnil used for?

Asoprisnil is an investigational small molecule being studied for uterine fibroids, leiomyoma, fibroid uterus, endometriosis, amenorrhea, and postmenopause. It has been evaluated in clinical trials for treating women with uterine fibroids and for use with estrogen in postmenopausal women.

What does Asoprisnil target?

Asoprisnil is a small molecule developed by Abbott Laboratories. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being studied for endocrine-related conditions including uterine fibroids and endometriosis.

Who makes Asoprisnil?

Asoprisnil is being developed by Abbott Laboratories, which trades under the ticker ABT. The company has sponsored clinical trials evaluating the drug for uterine fibroids and related gynecological conditions.

What phase is Asoprisnil in?

Asoprisnil is in Phase 2 and Phase 3 clinical development. It has completed five trials, including two Phase 3 studies for uterine fibroids and two Phase 2 studies for uterine fibroids and postmenopausal use. It remains investigational and is not FDA approved.

What clinical trials is Asoprisnil in?

Asoprisnil has completed five clinical trials, including NCT00150644, NCT00152256, NCT00152282, and NCT00156156. These trials studied the drug in women with uterine fibroids, leiomyoma, menorrhagia, metrorrhagia, amenorrhea, and postmenopause, with a total enrollment of 1,597 participants.

Is Asoprisnil the same as J867?

Asoprisnil is also known as J867, as referenced in the clinical trial title for NCT00150644. The drug has been studied under both names in trials for uterine fibroids and related conditions.