The vulvo-vaginal pain study:

INTERVENTION: Interventions; Double Blinded randomized allocation of active Pregabalin(Lyrica‐ Registered Trademark) or placebo vaginal aqueous cream twice daily for 6 weeks . At 6 weeks the option is provided for open label use of active cream for a further 6 weeks Randomization Randomization numbers will be generated by the Epidemiologist and patients will be allocated numbers by a research nurse, in order to keep the chief investigators blinded. Twenty millilitre calibrated syringes of active and placebo cream will only be labelled as cream A and B. Each syringe will have am identifying number for tracking. * Cream will be applied to vulvo‐vaginal area twice daily for 2 weeks initially. It will be kept at room temperature. Dosage of cream will be increased from starting dose at 2 weeks in consultation with the investigator if no response is obtained. Cream will be applied to the point of maximal pain. Participants will be interviewed at 2 weeks. If at or before 2 weeks side effects are experienced‐ subjects will be instructed to contact the investigator and discuss. Dosage reduction may be initially advised or cessation and a consultation will be organized for reassessment as soon as convenient. A different base such as Glycerine and Sorbelene might then be used. Dosage doubling will be scheduled if there is no response * Further Labelled Pregabalin cream will be provided at 6 weeks if the participant wishes. Treatment will continue for a further 6 weeks (12 weeks in total). Dosage of cream will again be increased 1 week later (i.e. week 7) in consultation with the CI if no response is noted, or reduced , adjusted if side effects are experienced. At the 6 week visit, any remaining cream from the 1st 6 weeks will be retrieved and examined for usage. At the 12 week point ‐ any remaining cream will be retrieved and examined for usage. Patients will be phoned when questionnaires are due to make sure these are completed and that cream is tolerated and being used * The dose (Lyrica registered trademark) Pregabalin will be 2.5% in concentration. This starting dose is equivalent to 25 mg of drug in 1 ml of cream used twice daily. If side effects are initially experienced, half the dose can be used twice daily by drawing up half the initial amount (0.5 ml). If no effect is initially observed, 2 mls can be used twice daily at 2 weeks; ie ‐ dose is doubled. * Participants with significantly impaired renal function will not be recruited to the study (e GFR < 60 or creatinine clearance < 60 mls/min). Those with mildly impaired renal function (e GFR >= 60) will receive the standard dosage but note will be made of this. Maximum oral dosage of (Lyrica registered trademark) Pregabalin is 300 mg . Guidelines suggest the drug is safe orally in those with renal impairment up to an oral dose of 150 mg twice daily. If dosage doubling is required in a participant where mild renal impairment is also present (Cr Cl 30‐60 ml/min); a dose adjustment will be calculated by consulting a renal physician for advice. * Subjects will complete a set of standardized questionnaires at regular intervals. The research nurse will remind them by phone. Questionnaires may be completed on line confidentially or posted. CONDITION: vulvo‐vaginal pain PRIMARY OUTCOME: a) Vulvo‐vaginal pain as assessed by a GRA pain scale 1. 0 (no pain) to 100 (worst possible pain) ; A pain scale is the most sensitive measure of pain severity over time and is the primary measure used to determine treatment efficacy ; b). Patients Global impression of change scale . This is another sensitive index of treatment response over time and its inclusion is recommend in pain trials. ; c) Sexual activity measured for those sexually active over time . ; 1. Female sexual function index . This is a standardised validated measure of sexual function ; Assessment of any effect of drug treatment on sexual function is relevant. ; ; SECONDARY OUTCOME: A) to document prevalence of local side effects, Non validated questions will be asked .Local irritation‐will be documented by questionnaire in a qualitative fashion. Results can be quantified later in a meaningful way depending on nature of responses ; B). Systemic effects and somnolence; oral administration of pregabalin causes somnolence rates of 20% . The first scale is ; ; 1. Drowsiness / somnolence/fatigue 0‐100 GRA scale . ; ; The main rationale for using Pregabalin as topical cream is to avoid drowsiness. Therefore a key secondary aim is to assess somnolence with use of the cream compared to placebo. ; B). Systemic effects and somnolence; oral administration of pregabalin causes somnolence rates of 20% . The second measure is ; ; ; 2. Sedation also using Karolinska sleepiness scale ; complaints of local side effects to the cream will be recorded qualitatively and later quantified for analysis as a secondary outcome measure. Sexual function is included here as a secondary outcome measure even though it will form a primary outcome measure as because no space is available for the Marinoff scale under primary outcome measures. ; The Marinoff sexual pain scale is another brief, validated measure of sexual function that will form a primary outcome measure. ; Sexual function is impacted upon by vaginal pain and is a primary complaint for most sexually active women. ; Urinary tract infection will be tested for at enrollment using a midstream urine sample and again throughout the study if there are suggestive symptoms of new onset frequency, urgency, incontinence, malodorous or cloudy urine. . Urinary tract infection will be tested for at baseline and later more because it could confound results‐ and not as a n outcome measure . Use of cream could possibly also cause infection and would be a possible secondary outcome measure ; ; Vaginal examination when clinically indicated will be performed to document prevalence of local side effects, ; Results will be recorded in a qualitative fashion. Results can be quantified later in a meaningful way depending on nature of responses 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 bladde