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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000655842

Acronym

TAV study. Topical Amitritpyline for the treatment of Vestibulodynia

Enrollment

Registered

2012-06-19

Start date

2012-05-28

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

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.

Outcome results