Rationale and design of a multicenter randomized clinical trial of extended release gabapentin in provoked vestibulodynia and biological correlates of response

Candace Brown, David C. Foster, Jim Wan, Leslie A. Rawlinson, Gloria A. Bachmann

Research output: Contribution to journalArticle

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Abstract

Introduction: Few randomized controlled trials (RCTs) have been conducted to establish evidence-based management protocols for provoked vestibulodynia (PVD), a chronic vulvar pain condition affecting approximately 14. million women in the U.S. We describe the rationale and design of an NIH funded multicenter clinical trial utilizing an extended release formulation of gabapentin (G-ER), an intervention that preliminary data suggest may be efficacious for this condition. Objectives: 1) to determine if pain from tampon insertion (primary outcome measure) is lower in PVD patients when treated with G-ER compared to when treated with placebo and 2) to determine if G-ER reduces vulvar mechanical hyperalgesia, vaginal muscle pain to palpation, the number and intensity of somatic tenderpoints, spontaneous and provoked pain to intradermal capsaicin with an accompanying increase in cardiac beat-to-beat variability and to identify mechanistically-based PVD subtypes. Additional outcomes include subject reported intercourse pain and summative 24-hour pain. Methods: This 16-week, randomized, double-blind, placebo-controlled, crossover study will enroll 120 women 18. years and older who report tenderness localized to the vulvar vestibule, pain with tampon insertion, and, when sexually active, insertional dyspareunia. Electronically entered daily diaries will be used to determine if pain is lower in PVD subjects when treated with G-ER (up to 3000. mg/d) compared to when treated with placebo. Psychophysiological measures will be obtained at baseline and after 2. weeks at the maximum tolerated dose. Conclusion: We will conduct the first multicenter RCT to confirm efficacy of an agent that is currently used in clinical practice for treating PVD.

Original languageEnglish (US)
Pages (from-to)154-165
Number of pages12
JournalContemporary Clinical Trials
Volume36
Issue number1
DOIs
StatePublished - Sep 1 2013

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Vulvodynia
Randomized Controlled Trials
Pain
Placebos
Dyspareunia
Maximum Tolerated Dose
Palpation
Capsaicin
Myalgia
Hyperalgesia
Chronic Pain
Cross-Over Studies
Multicenter Studies
gabapentin
Outcome Assessment (Health Care)
Clinical Trials

All Science Journal Classification (ASJC) codes

  • Pharmacology (medical)

Cite this

Rationale and design of a multicenter randomized clinical trial of extended release gabapentin in provoked vestibulodynia and biological correlates of response. / Brown, Candace; Foster, David C.; Wan, Jim; Rawlinson, Leslie A.; Bachmann, Gloria A.

In: Contemporary Clinical Trials, Vol. 36, No. 1, 01.09.2013, p. 154-165.

Research output: Contribution to journalArticle

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