The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000655842
Ethics application status
Approved
Date submitted
18/06/2012
Date registered
19/06/2012
Date last updated
14/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is amitriptyline cream effective in the management of vestibulodynia - a condition which refers to pain at the opening of the vagina?
Scientific title
An experimental study to determine whether amitriptyline is more effective than placebo in the management of vestibulodynia. A double-blind, randomised, placebo-controlled trial
Secondary ID [1] 280512 0
Nil
Universal Trial Number (UTN)
Trial acronym
TAV study. Topical Amitritpyline for the treatment of Vestibulodynia
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vestibulodynia 286501 0
Condition category
Condition code
Anaesthesiology 286761 286761 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 - Topical amitritpyline 5% in versabase cream. Apply a small amount to the affected area twice a day for a period of 3 months. A 'wash-out' of 1 week will occur before starting the second treatment.
Intervention code [1] 284886 0
Treatment: Drugs
Comparator / control treatment
Arm 2 - placebo. Versabase cream
Control group
Placebo

Outcomes
Primary outcome [1] 287147 0
Primary Outcome: McGill pain questionnaire
Timepoint [1] 287147 0
Timepoint: Baseline, immediatly after treatment period of each group (3 months & 6 months) and 1 month after completion of treatment period.
Primary outcome [2] 287148 0
Primary Outcome: Marinoff and Turner grading system for dyspareunia
Timepoint [2] 287148 0
Timepoint: Baseline, immediately after treatment period of each group (3 months & 6 months) and 1 month after completion of treatment period.
Secondary outcome [1] 297496 0
Nil
Timepoint [1] 297496 0
Nil

Eligibility
Key inclusion criteria
Women aged 18 and older presenting with provoked localised vestibulodynia classified according to 2003 International Society for the Study of Vulvar Disease classification will be eligible for inclusion. Primary vaginismus will be excluded in all participants after physical examination.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have undergone a vestibulectomy, been previously treated with amitriptyline cream or are currently pregnant will be excluded. If a patient is found to have active vaginal or pelvic infection or vaginal candidiasis then treatment must be given prior to enrolment in the study.
Patients who cannot speak English or give adequate consent will also be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following screening, patients will be randomly allocated into one of two groups AB or BA. Group AB will receive the amitriptyline cream for three months followed by a one week washout period then the placebo cream for a further three months. Group BA will receive the placebo cream for three months followed by a one week washout period and then amitriptyline cream for a further three months.

Patients were allociated a study number at the time of recruitment. Patients were randomally allocated to group AB or group BA depending their study number and the randomisation schedule. Randomisation was completed by the pharmacy department so both the doctors and patients are unaware of which group they are in.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random sequence was generated by Microsoft Excel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Nil
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285276 0
Hospital
Name [1] 285276 0
The Royal Womens Hospital
Address [1] 285276 0
Corner of Grattan street & Flemington road
Parkville, VIC 3052
Country [1] 285276 0
Australia
Primary sponsor type
Individual
Name
Dr Ross Pagano
Address
The Royal Womens Hospital
Corner of Grattan street & Flemington road
Parkville, VIC 3052
Country
Australia
Secondary sponsor category [1] 284136 0
None
Name [1] 284136 0
Address [1] 284136 0
Country [1] 284136 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287289 0
The Royal Womens Hospital
Ethics committee address [1] 287289 0
Corner of Grattan street & Flemington Road
Parkville, VIC 3052
Ethics committee country [1] 287289 0
Australia
Date submitted for ethics approval [1] 287289 0
Approval date [1] 287289 0
28/05/2012
Ethics approval number [1] 287289 0
12/05

Summary
Brief summary
The aim of this project is to evaluate whether amitriptyline 5% cream is an effective treatment for a condition known as “vestibulodynia”, which refers to pain at the opening of the vagina. Pain is felt when any pressure is applied to this area.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34195 0
Address 34195 0
Country 34195 0
Phone 34195 0
Fax 34195 0
Email 34195 0
Contact person for public queries
Name 17442 0
Lisa Wolke
Address 17442 0
The Royal Womens Hospital
Corner of Grattan street & Flemington Road
Parkville VIC 3052
Country 17442 0
Australia
Phone 17442 0
+61 3 83453187
Fax 17442 0
Email 17442 0
lisa.wolke@thewomens.org.au
Contact person for scientific queries
Name 8370 0
Dr Ross Pagano
Address 8370 0
The Royal Womens Hospital
Corner of Grattan street & Flemington Road
Parkville VIC 3052
Country 8370 0
Australia
Phone 8370 0
+61 3 83452000
Fax 8370 0
Email 8370 0
PaganoR@ramsayhealth.com.au

No information has been provided regarding IPD availability
Summary results
No Results