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Levitra

Phase 3

Erectile Dysfunction | Small molecule | Endocrine |Amgen Inc.|Last Updated: Dec 25, 2014

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment130

FDA Designations

No designations recorded

Clinical trial landscape

Levitra · 1 trial · 1 indication

Phase 3 1
NCT00657644Efficacy and Safety of Vardenafil in Men With Erectile DysfunctionErectile Dysfunction
COMPLETED130 Analytics
PHASE3COMPLETED
Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction
Erectile DysfunctionUnlock trial analytics

Study Endpoints

Primary Endpoints

Erectile Function (EF) domain score
Week 12

Secondary Endpoints

Erectile Function (EF) domain score
Week 4, 8 and 12 Last Observation Carried Forward (LOCF)
Change from baseline of Erectile Function domain score
Week 4, 8 and 12 Last Observation Carried Forward (LOCF)
IIEF domain scores
Week 4, 8, 12 and 12 Last Observation Carried Forward (LOCF)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -

Interventions

NameTypeDescription
Levitra (Vardenafil, BAY38-9456)DRUG4 weeks treatment with 10 mg vardenafil followed by a flexible titration phase for 8 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Males with ED according to the NIH definition (the inability to achieve or maintain penile erection sufficient for satisfactory sexual performance) for at least 3 months. * Heterosexual relationship * Age range: 18 years and older * Documented written Informed Consent * The su...

Countries:Russia
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Frequently asked questions about Levitra

What is Levitra used for?

Levitra is used for erectile dysfunction. It is a small molecule being developed by Amgen Inc. (AMGN) for this condition. The drug is currently in Phase 3 clinical development.

Who makes Levitra?

Levitra is being developed by Amgen Inc., which trades under the ticker AMGN. The drug is in Phase 3 clinical development for erectile dysfunction.

What phase is Levitra in?

Levitra is in Phase 3 clinical development. It is an investigational drug for erectile dysfunction and has not been approved by the FDA.

What clinical trials is Levitra in?

Levitra has one completed Phase 3 trial, NCT00657644, titled 'Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction.' This trial enrolled 130 male participants aged 18 years and older in Russia.

Is Levitra FDA approved?

Levitra is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for erectile dysfunction, with one completed clinical trial.