RecruitingPhase 3ACTRN12612000655842

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


Sponsor

Dr Ross Pagano

Enrollment

50 participants

Start Date

May 28, 2012

Study Type

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

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether a cream containing amitriptyline (a medication usually used for nerve pain and depression) can relieve pain at the opening of the vagina, a condition called vestibulodynia. Women with this condition feel pain whenever pressure is applied to that area. The cream is applied directly to the skin and may reduce pain signals in the area. You may be eligible if: - You are a woman aged 18 or older - You have been diagnosed with provoked localized vestibulodynia (pain at the vaginal opening when touched) You may NOT be eligible if: - You have already had surgery to remove the painful tissue (vestibulectomy) - You have been treated with amitriptyline cream before - You are currently pregnant - You have an active vaginal or pelvic infection or yeast infection at the time of enrollment - You are unable to read or communicate in English Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 trea

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)

Australia

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