Is amitriptyline cream effective in the management of vestibulodynia - a condition which refers to pain at the opening of the vagina?
An experimental study to determine whether amitriptyline is more effective than placebo in the management of vestibulodynia. A double-blind, randomised, placebo-controlled trial
Dr Ross Pagano
50 participants
May 28, 2012
Interventional
Conditions
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.
Eligibility
Inclusion Criteria1
- 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.
Exclusion Criteria2
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12612000655842