The vulvo-vaginal pain study:A study looking at the effectiveness of an intra-vaginal cream for treatment of chronic vulvo-vaginal pain. .

Phase 2

• Conditions: vulvo-vaginal pain; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12614001153606
• Lead Sponsor: Dr Jane Manning

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-31
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

*INCLUSION; Unable to insert tampon or have penetrative vulvo-vaginal intercourse or to tolerate regular vulvo-vaginal examination
*There may be also discomfort wearing tight clothing, discomfort sitting, mobilizing
*Other causes of pain must have been excluded by swab, biopsy and / or skin scraping if necessary. Participants will be reviewed by a female dermatologist with a clinical and research interest in vaginal pain. Diagnoses of local trauma, scarring, candida, HSV, other dermatoses- lichen simplex etc will only exclude participation if appropriate treatment for these diagnoses has been provided but has not resolved the symptom substantially.

* Pain must be present persistently for greater or equal to 6 months
* Maximum Pain Severity was / is > 50 on Gra scale 1-100 on greater or equal to 2 occasions in 1 week

*Other associated pelvic pain conditions do not exclude inclusion; such as interstitial cystitis/ painful bladder syndrome), endometriosis, rectal pain, provided focal vulvo-vaginal examination is also uncomfortable
Can include past use of oral Gabapentin or Pregabaln with or without side effects.
Participants may come from clinics at RPAH or from elsewhere

Exclusion Criteria

*Vulvo-vaginal or vulval pain of known and effectively treatable cause ie it is not refractory to other treatment
*Pregnancy or risk of pregnancy (unprotected intercourse). If risk suspected HCG testing prior to randomization
Age 17 or under
*Lichen planus/sclerosis will exclude participation
*Untreated pelvic malignancy, past or current radiation therapy.
*Known allergy to Gabapentin , Pregabalin

*Pain present persistently for less than 6 months
* If the maximum Pain Severity was never > 50 on Gra scale 1-100 on < 2 occasions in 1 week.

*Severe renal impairment (Cr Cl or e GFR < 60) or recent (less than 12 months) acute myocardial infarct.
* They live more than 200 km from Sydney

Study & Design

• Study Type: Interventional
• Study Design: Not specified