Vardenafil in Tinnitus

NCT00666809 | Completed Phase 2

• 2 other identifiers: 120492006-000463-29
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

There is incidental evidence (casuistic findings) that the treatment with vardenafil of male patients suffering from erectile dysfunction and comorbid tinnitus experienced an improvement of their tinnitus. Randomized, parallel-group, double-blind, placebo-controlled trial over 16 weeks (12 weeks of treatment + 4 weeks follow-up) with 10 mg vardenafil BID p.o. in men and women with chronic tinnitus.

Conditions

Tinnitus

Keywords

Vardenafil,; Tinnitus

Outcome Measures

Primary Outcomes (1)

• Total score of the Tinnitus

  4 times in 16 weeks

Secondary Outcomes (4)

• Audiometric measurements (mode, frequency and loudness of tinnitus, pure tone audiogram, speech audiogram)

  16 weeks

• Quality of life (SF 36 Questionnaire)

  16 weeks

• Serum human chorionic Gonadotropin (hcG), pregnancy test

  once at screening

• Safety and tolerability

  16 weeks

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Drug: Levitra (Vardenafil, BAY38-9456)

Arm 2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Levitra (Vardenafil, BAY38-9456) DRUG

Vardenafil 10 mg BID p.o. for 12 weeks + 4 weeks follow-up

Arm 1

Placebo DRUG

Placebo BID p.o. for 12 weeks + 4 weeks follow-up

Arm 2

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Chronic subjective cochlear tinnitus
• No treatment of tinnitus within 4 weeks prior to study entry
• Duration of tinnitus \> 3 months

You may not qualify if:

• Acute tinnitus
• Intermittent tinnitus
• History of M. Menieré
• History of conductive deafness
• History of psychogenic deafness
• History of tumors of the middle ear, inner ear or cerebella-pontine angle (malignant and non malignant)
• Patients diagnosed of multiple sclerosis
• History of myocardial infarction, stroke, or life-threatening arrhythmia within the prior 6 months
• Nitrates or nitric oxide donors
• Any other concurrent treatment of tinnitus during study
• pregnant and breast-feeding women
• women with child-bearing potential not using adequate birth control method (Note: as adequate method of birth control oral contraception, spiral or sexual abstinence is recommended)

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Berlin, Berlin / 285, 10117, Germany

Location

Related Links

• click here and search for Bayer product information provided by the EMA

MeSH Terms

Conditions

Tinnitus

Interventions

Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2008
• First Posted: April 25, 2008
• Study Start: October 1, 2006
• Study Completion: May 1, 2007
• Last Updated: December 9, 2014

Record last verified: 2014-12

Locations

DE (1)