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Levitra

Phase 3

Erectile Dysfunction | Small molecule | Endocrine |Bayer AG|Last Updated: Mar 6, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials17
Total Enrollment7,861

FDA Designations

No designations recorded

Clinical trial landscape

Levitra · 19 trials · 8 indications

Phase 3 15Phase 2 4
NCT00492635Study to Compare the Tolerability and Efficacy of Once Daily Vardenafil vs Vardenafil PRN vs Placebo in Men Immediately After Nerve-sparing Prostatectomy for Improving EDErectile Dysfunction
COMPLETED628 Analytics
NCT00652262BAY38-9456 - Supportive Trial for Spinal InjuryErectile Dysfunction
COMPLETED32 Analytics
NCT00678704BAY38-9456 - Pivotal Trial for Diabetes PatientErectile Dysfunction
COMPLETED790 Analytics
NCT00668109Assessment of Efficacy of Vardenafil in Subjects With Erectile Dysfunction and Diabetes, Hypertension or HyperlipidemiaErectile Dysfunction
COMPLETED614 Analytics
NCT00682019Study Evaluation the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction for 10 WeeksErectile Dysfunction
COMPLETED383 Analytics
NCT00657033Study to Investigate the Efficacy and Safety of Vardenafil Flexible Dose Versus Placebo in Males With Erectile DysfunctionErectile Dysfunction
COMPLETED229 Analytics
NCT00661297Study Evaluating the Efficacy, Safety, and Reliability of VardenafilErectile Dysfunction
COMPLETED523 Analytics
NCT00665496A Study to Investigate the Time to Onset of Action of 10 mg and 20 mg of Vardenafil Compared to Placebo in Males With Erectile DysfunctionErectile Dysfunction
COMPLETED732 Analytics
NCT00661115To Investigate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction.Erectile Dysfunction
COMPLETED173 Analytics
NCT00661596Assessment of Efficacy of Vardenafil, Influence on Self-esteem and Self-confidence in Subjects With Erectile DysfunctionErectile Dysfunction
COMPLETED129 Analytics
PHASE3COMPLETED
Study to Compare the Tolerability and Efficacy of Once Daily Vardenafil vs Vardenafil PRN vs Placebo in Men Immediately After Nerve-sparing Prostatectomy for Improving ED
Erectile Dysfunction
NCT00492635628
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PHASE3COMPLETED
BAY38-9456 - Supportive Trial for Spinal Injury
Erectile Dysfunction
NCT0065226232
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PHASE3COMPLETED
BAY38-9456 - Pivotal Trial for Diabetes Patient
Erectile Dysfunction
NCT00678704790
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PHASE3COMPLETED
Assessment of Efficacy of Vardenafil in Subjects With Erectile Dysfunction and Diabetes, Hypertension or Hyperlipidemia
Erectile Dysfunction
NCT00668109614
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PHASE3COMPLETED
Study Evaluation the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction for 10 Weeks
Erectile Dysfunction
NCT00682019383
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PHASE3COMPLETED
Study to Investigate the Efficacy and Safety of Vardenafil Flexible Dose Versus Placebo in Males With Erectile Dysfunction
Erectile Dysfunction
NCT00657033229
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PHASE3COMPLETED
Study Evaluating the Efficacy, Safety, and Reliability of Vardenafil
Erectile Dysfunction
NCT00661297523
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PHASE3COMPLETED
A Study to Investigate the Time to Onset of Action of 10 mg and 20 mg of Vardenafil Compared to Placebo in Males With Erectile Dysfunction
Erectile Dysfunction
NCT00665496732
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PHASE3COMPLETED
To Investigate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction.
Erectile Dysfunction
NCT00661115173
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PHASE3COMPLETED
Assessment of Efficacy of Vardenafil, Influence on Self-esteem and Self-confidence in Subjects With Erectile Dysfunction
Erectile Dysfunction
NCT00661596129
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Study Endpoints

Primary Endpoints

Determine whether early, NIGHTLY dosing with vardenafil Significantly improves recovery of erectile function after surgery as compared to placebo, and whether early PRN dosing with vardenafil also improves recovery of function as compared to placebo
9 months
The Erectile Function (EF) domain score of IIEF calculated as the sum of scores from Questions 1 to 5 and 15
At 12 weeks after start of study drug administration using data at LOCF to account for dropouts
Sexual encounter profile question 3 observed within 15 minutes to 4 hours for vardenafil and 22 to 26 hours for the tadalafil group
4 weeks
Per-patient success rates based on Sexual Encounter Profile, Question 3
10 weeks
The primary measures of efficacy in this study will be improved success of erection maintenance in men with ED and improvement in female partner's sexual quality of life.
Weeks 0 -12
Sexual Encounter Profile question 2 (SEP 2)
12 weeks
- Earliest elapsed time from dosing to attainment of an erection perceived to be adequate for penetration leading to completion of successful intercourse as measured by Sexual Encounter Profile Question 3 (SEP 3)
First four doses with successful intercourse
Erectile function (EF) domain score of the International Index of Erectile Function (IIEF)calculated as the sum of scores from Questions 1 to 5 and 15
At Week 12 using the Last Observation Carried Forward (LOCF) method to account for dropouts.
International Index of Erectile Function - Erectile Function Domain
12 weeks
Percentage of success rate at the end of treatment period versus baseline.
At baseline, after 12 weeks
The primary efficacy comparison is EF domain of the IIEF, vardenafil preferred dose versus placebo at week 18 (after 4 weeks of preferred treatment).
At week 18 (after 4 weeks of preferred treatment).
Successful attempt rate reported between drug ingestion and a maximum of 6 hours after drug intake
12 weeks
The primary efficacy variables are the change from baseline in the IIEF-EF domain score and the change from baseline in the HAM-D17 total score.
12 weeks and LOCF
Erectile Function domain score of the International Index of Erectile Function, questions 1-5 and 15
12 weeks
Total score of the Tinnitus
4 times in 16 weeks
Erectile Dysfunction change score from baseline of the ED change score from baseline of the International Index of Erectile Function (IIEF-EF)
12- 24 weeks
International Prostate Symptom Score and maximal urinary flow
8 weeks
Erectile Function domain of the International Index of Erectile Function
12 weeks
Sexual Encounter Profile Question 2
12 weeks
Sexual Encounter Profile Question 3
12 weeks

Secondary Endpoints

Assess whether early dosing of either NIGHTLY or PRN vardenafil over 9 months, followed by 2 months of withdrawal, increases efficacy of subsequent PRN use significantly better than placebo
13 months
The Global Assessment Question
At 4, 8, 12 weeks after start of study drug administration and LOCF
The IIEF EF domain score
At 4, 8, 12 weeks after start of study drug administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2EXPERIMENTAL -
Arm 3PLACEBO_COMPARATOR -
Arm 4PLACEBO_COMPARATOR -
Arm 5PLACEBO_COMPARATOR -
Arm 6PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Levitra (Vardenafil, BAY38-9456)DRUG9 months DAILY dosage (double blind) 2 months single-blind placebo wash-out period (subject only is blinded) 2 months open-label PRN treatment with active medication
PlaceboDRUG9 months placebo (double blind)2 months single-blind placebo wash-out period (subject only is blinded)2 months open-label PRN treatment with active medication
TadalafilDRUG10 mg taken approximately 24 hours prior to sexual intercourse
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Eligibility Criteria

Age Range18 Years to 64 Years
SexMALE
Healthy VolunteersNo
Study Sites86

Inclusion Criteria: At Screening * Males 18-64 years of age * Scheduled to undergo bilateral nerve-sparing radical retropubic BNSRRP, as selected according to the investigator's usual clinical practice * Surgery scheduled within about 1 month of screening (Visit 1) * Expressed an interest in resum...

Countries:United StatesAustriaBelgiumCanadaFinlandFranceGermanyItalyNetherlandsNorwaySouth AfricaSpainSwedenSwitzerlandUnited KingdomJapanColombiaIsraelMexicoPeruPolandIndiaIrelandChina
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Frequently asked questions about Levitra

What is Levitra used for?

Levitra is used for erectile dysfunction, tinnitus, and benign prostatic hyperplasia. It is a small molecule developed by Bayer AG (ticker: BAYRY) and is currently in Phase 2 clinical development for these indications.

What does Levitra target?

Levitra targets the PDE5 enzyme, which is involved in the regulation of blood flow. By inhibiting PDE5, it helps increase blood flow to specific areas of the body, which can be beneficial in treating conditions like erectile dysfunction.

Who makes Levitra?

Levitra is developed by Bayer AG, a pharmaceutical company traded under the ticker BAYRY. The drug is currently in Phase 2 clinical trials for its approved and investigational uses.

What phase is Levitra in?

Levitra is in Phase 2 clinical development. It has completed 17 trials with a total enrollment of 7,861 participants. All trials have been completed, with no active trials currently ongoing.

What clinical trials is Levitra in?

Levitra has been studied in several clinical trials, including NCT00654914 for erectile dysfunction, NCT00656188 for erectile dysfunction, NCT00666809 for tinnitus, and NCT00786253 for erectile dysfunction. These trials have all been completed.

Is Levitra the same as vardenafil?

Yes, Levitra is the brand name for vardenafil. Clinical trials often refer to the drug as vardenafil, and it is used to treat conditions such as erectile dysfunction and tinnitus.