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Asoprisnil

Phase 2

Menorrhagia | Small molecule | Other |Bayer AG|Last Updated: Dec 30, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Clinical trial landscape

Asoprisnil · 1 trial · 1 indication

Phase 2 1
NCT00288691Menorrhagia Study in Women With Treatment-resistant MenorrhagiaMenorrhagia
COMPLETED26 Analytics
PHASE2COMPLETED
Menorrhagia Study in Women With Treatment-resistant Menorrhagia
MenorrhagiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Individual relative change in uterine bleeding scores by PBAC
Pretreatment cycle treatment phase

Secondary Endpoints

Endometrial thickness
End of treatment
Adverse events collection
Whole treatment period
Bleeding pattern
Treatment period
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

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

Interventions

NameTypeDescription
Asoprisnil (BAY86-5294)DRUG5mg/day
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range30 Years to 55 Years
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Patients with treatment-resistant menorrhagia scheduled for hysterectomy. Exclusion Criteria: * Organic causes of menorrhagia * Current hormone treatment

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Frequently asked questions about Asoprisnil

What is Asoprisnil used for?

Asoprisnil is an investigational small molecule being studied for the treatment of menorrhagia, a condition characterized by heavy menstrual bleeding. It is being developed by Bayer AG and is currently in Phase 2 clinical development.

Who makes Asoprisnil?

Asoprisnil is being developed by Bayer AG, a multinational pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY.

What phase is Asoprisnil in?

Asoprisnil is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. It is being studied for the treatment of menorrhagia.

What clinical trials is Asoprisnil in?

Asoprisnil has been studied in a Phase 2 clinical trial with the identifier NCT00288691, titled 'Menorrhagia Study in Women With Treatment-resistant Menorrhagia'. This trial was completed and enrolled 26 female participants aged 30 years and older.

Is Asoprisnil the same as any other drug?

No alternative names for Asoprisnil have been reported. It is referred to solely by its generic name, Asoprisnil, in clinical and research contexts.