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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Sildenafil For Meniere's Disease
Scientific title
A Multicentre, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study Of The Efficacy and Safety Of Sildenafil Given For The Acute Treatment Of Meniere's Disease
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Meniere's Disease 0 0
Condition category
Condition code
Ear 0 0 0 0
Other ear disorders

Study type
Description of intervention(s) / exposure
Treatment: Drugs - Sildenafil

Treatment: Drugs: Sildenafil

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Vertigo Response (4 x 6 point scale); Balance (6 point scale)
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Hearing/Tinnitus; Ear, Nose & Pressure/Fullness; Perf. daily activities; Nausea; Vomiting; Func. Response; Duration of the Attack and Vertigo; Rescue Medications Use; Acceptability to subject; Composite Assessment Score; Comparison to Previous Attack
Timepoint [1] 0 0

Key inclusion criteria
- Active Meniere's disease (2 or more definitive spontaneous episodes of vertigo 20
minutes or longer, plus hearing loss on at least 1 occasion, tinnitus or aural
fullness) with confirmed diagnosis
Minimum age
18 Years
Maximum age
75 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Pregnant or breast feeding females or fertile females unwilling to use agreed
contraceptive methods

- severe Meniere's diseased (more than 8 attacks per month)

- previous ear surgery

- intratympanic perfusions of steroids or gentamicin; requiring other medications
contraindicated for Viagra (eg. nitrates)

- with medical conditions that make Viagra contraindicated

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Bondi Junction
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Brisbane
Recruitment hospital [3] 0 0
Pfizer Investigational Site - East Melbourne
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
- Bondi Junction
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- East Melbourne
Recruitment postcode(s) [4] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry

Ethics approval
Ethics application status

Brief summary
Meniere's disease affects a person's sense of balance. An attack can last 20 minutes to 2
hours or longer. Symptoms include rotational vertigo, hearing loss, tinnitus and a sensation
of fullness in the affected ear and may be associated with nausea and vomiting. One
hypothesis is that Meniere's disease is caused by the excessive accumulation of fluid in the
balance tubes within the inner ear. Sildenafil may alleviate the symptoms due to its
vasodilatory activity. The purpose of this study is to assess the safety and efficacy of
sildenafil (Viagra) compared with placebo on symptoms during one acute attack.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Pfizer Call Center
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications