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Asoprisnil/Premarin

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment105

FDA Designations

No designations recorded

Clinical trial landscape

Asoprisnil/Premarin · 2 trials · 2 indications

Phase 2 2
NCT00152295A Long-Term Study to Evaluate the Safety of Asoprisnil and Estrogen Administration to Postmenopausal WomenPostmenopause
COMPLETED18 Analytics
NCT00152282A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal WomenAmenorrhea
COMPLETED105 Analytics
PHASE2COMPLETED
A Long-Term Study to Evaluate the Safety of Asoprisnil and Estrogen Administration to Postmenopausal Women
Postmenopause
NCT0015229518
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PHASE2COMPLETED
A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal Women
Amenorrhea
NCT00152282105
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Study Endpoints

Primary Endpoints

The percent of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System.
Throughout Study
The percentage of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System
Months 3,6
Change from baseline in endometrial thickness (mm) as measured by transvaginal ultrasound.
Months 3,6
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 assessed via daily diary.
Throughout study
Frequency and severity of hot flushes assessed via daily diary.
Throughout study
Mean change from baseline in endocrine determinations.
Months 2,4,and 6
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

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

Interventions

NameTypeDescription
Asoprisnil/PremarinDRUG10 mg (2-5mg tablets) asoprisnil and 0.625 mg Premarin tablets, oral daily for 6 months
Placebo and PremarinDRUGPlacebo and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
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Eligibility Criteria

Age Range48 Years to 65 Years
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Successful completion of study M00-198 * Continued good general health * Negative urine pregnancy test Exclusion Criteria: * History of known or suspected cancer other than basal cell carcinoma in last 5 years * History of reproductive endocrine disorder * Submucous or other...

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Frequently asked questions about Asoprisnil/Premarin

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.