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Levitra

Phase 3

Erectile Dysfunction | Small molecule | Endocrine |GSK plc|Last Updated: Dec 16, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment851

FDA Designations

No designations recorded

Clinical trial landscape

Levitra · 2 trials · 1 indication

Phase 3 2
NCT00658177Study Evaluating the Efficacy and Safety of Flexible-dose Vardenafil in Subjects With Erectile DysfunctionErectile Dysfunction
COMPLETED463 Analytics
NCT00668005Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction and HypertensionErectile Dysfunction
COMPLETED388 Analytics
PHASE3COMPLETED
Study Evaluating the Efficacy and Safety of Flexible-dose Vardenafil in Subjects With Erectile Dysfunction
Erectile DysfunctionUnlock trial analytics
PHASE3COMPLETED
Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction and Hypertension
Erectile DysfunctionUnlock trial analytics

Study Endpoints

Primary Endpoints

Sexual Encounter Profile Question 2
12 weeks
Sexual Encounter Profile (SEP), questions 2 and 3
12 weeks

Secondary Endpoints

Sexual Encounter Profile Question 3
12 weeks
Internation Index of Erectile Function-Erectile Function domain
12 weeks
Safety and tolerability
12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Levitra (Vardenafil, BAY38-9456)DRUG20mg to be taken 1 h prior to sexual intercourse
PlaceboDRUGMatching placebo
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo

Inclusion Criteria: * Men \>/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement, * History of unresponsiveness to sildenafil * Stable sexual relationship for \> 6 month. Exclusion Criteria: * Primary hypoactive sexual desire * History of myocardial in...

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Frequently asked questions about Levitra

What is Levitra used for?

Levitra is used for the treatment of erectile dysfunction in men. It is a small molecule being developed by GSK plc (ticker: GSK) and is currently in Phase 3 clinical development. Two Phase 3 trials have been completed, studying its efficacy and safety in men with erectile dysfunction.

Who makes Levitra?

Levitra is being developed by GSK plc, which trades under the ticker GSK. The drug is currently in Phase 3 clinical development for erectile dysfunction. GSK has completed two Phase 3 trials evaluating Levitra in this indication.

What phase is Levitra in?

Levitra is in Phase 3 clinical development for erectile dysfunction. Two Phase 3 trials have been completed, both of which were randomized, double-blind, and placebo-controlled. The drug is investigational and has not been approved by regulatory authorities based on the available data.

What clinical trials is Levitra in?

Levitra has been studied in two completed Phase 3 clinical trials. The first, NCT00658177, evaluated flexible-dose vardenafil in subjects with erectile dysfunction and enrolled 463 participants. The second, NCT00668005, evaluated vardenafil in subjects with erectile dysfunction and hypertension, enrolling 388 participants.

Is Levitra the same as vardenafil?

Levitra is the brand name for vardenafil, a small molecule used to treat erectile dysfunction. The clinical trials for Levitra, including NCT00658177 and NCT00668005, refer to vardenafil as the active substance. Both trials were Phase 3, randomized, double-blind, and placebo-controlled.