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SAR407899

Phase 2

Erectile Dysfunction | Small molecule | Endocrine |Sanofi|Last Updated: May 2, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

SAR407899 · 1 trial · 1 indication

Phase 2 1
NCT00914277SAR407899 Single-dose in Treatment of Mild to Moderate Erectile DysfunctionErectile Dysfunction
COMPLETED24 Analytics
PHASE2COMPLETED
SAR407899 Single-dose in Treatment of Mild to Moderate Erectile Dysfunction
Erectile DysfunctionUnlock trial analytics

Study Endpoints

Primary Endpoints

Duration of penile rigidity during sexual stimulation
4 hours following drug administration

Secondary Endpoints

Time to onset of penile rigidity
4 hours following drug administration
Blood pressure
12 hours following drug administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Sequence 1EXPERIMENTALPeriod 1: placebo Period 2: sildenafil Period 3: SAR407899 dose level 2 Period 4: SAR407899 dose level 1
Sequence 2EXPERIMENTALPeriod 1: sildenafil Period 2: SAR407899 dose level 1 Period 3: placebo Period 4: SAR407899 dose level 2
Sequence 3EXPERIMENTALPeriod 1: SAR407899 dose level 1 Period 2: SAR407899 dose level 2 Period 3: sildenafil Period 4: placebo
Sequence 4EXPERIMENTALPeriod 1: SAR407899 dose level 2 Period 2: placebo Period 3: SAR407899 dose level 1 Period 4: sildenafil

Interventions

NameTypeDescription
SAR407899DRUGOral administration
PlaceboDRUGOral administration
SildenafilDRUGOral administration
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Eligibility Criteria

Age Range18 Years to 60 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * male with mild to moderate erectile dysfunction for at least 6 months * written informed consent Exclusion Criteria: * diabetes mellitus * orthostatic hypotension * hypogonadal testosterone level The above information is not intended to contain all considerations relevant t...

Countries:France
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Frequently asked questions about SAR407899

What is SAR407899 used for?

SAR407899 is an investigational small molecule being studied for the treatment of mild to moderate erectile dysfunction. It is in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes SAR407899?

SAR407899 is being developed by Sanofi, a global biopharmaceutical company traded on the stock exchange under the ticker symbol SNY. The drug is currently in Phase 2 clinical trials for erectile dysfunction.

What phase is SAR407899 in?

SAR407899 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies and is still being evaluated in clinical trials for safety and efficacy.

What clinical trials is SAR407899 in?

SAR407899 has one completed Phase 2 clinical trial, identified as NCT00914277, titled 'SAR407899 Single-dose in Treatment of Mild to Moderate Erectile Dysfunction.' This randomized, double-blind, controlled study enrolled 24 male participants in France.

Is SAR407899 FDA approved?

SAR407899 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for erectile dysfunction. The drug has completed one clinical trial but has not yet received regulatory approval.