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Asoprisnil

Phase 3

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

Asoprisnil development status

Highest phase Phase 3 run by Abbott (NCT00156195)
Phase scored for BAYRYPhase 2
Registered trials 12 across 1 sponsor since Sep 2005

Asoprisnil target and mechanism

Molecular targetPGR
Target classModulator
ModalitySmall molecule

Also known as Asoprisnil (BAY86-5294)

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

Asoprisnil clinical trials

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, or heavy menstrual bleeding. It has been evaluated in women with treatment-resistant menorrhagia. It is not approved for any indication and remains in clinical development.

What does asoprisnil target?

Asoprisnil targets the progesterone receptor, or PGR. It acts as a modulator of that receptor, meaning it binds the progesterone receptor and alters its signaling rather than simply blocking or activating it. This receptor-modulating activity is the basis for its study in heavy menstrual bleeding.

Who is developing asoprisnil?

Asoprisnil is being developed by Bayer AG, which trades over the counter in the United States under the ticker BAYRY. Bayer holds the development program for the compound, which is also referenced as BAY86-5294.

What phase is asoprisnil in?

Asoprisnil is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency for menorrhagia or any other indication. The Phase 2 program has completed its listed trial.

What clinical trials is asoprisnil in?

Asoprisnil has been studied in one Phase 2 trial, NCT00288691, titled Menorrhagia Study in Women With Treatment-resistant Menorrhagia. That trial is completed and enrolled 26 female participants aged 30 years and older. It was randomized, double-blind, and placebo-controlled.

Is asoprisnil the same as BAY86-5294?

Yes. Asoprisnil is also known as BAY86-5294, which is Bayer's internal compound designation for the same drug. Both names refer to the same investigational progesterone receptor modulator being studied for menorrhagia, so searches for either name point to the same asset.