A Pilot Study on the Efficacy of Oral Low Dose Naltrexone for Vulvodynia

Summary

The goal of this observational pilot study is to assess the safety, efficacy, and tolerability of oral low dose naltrexone (LDN) in the treatment of vulvodynia. The aims it will address are: Aim 1:To assess the efficacy of LDN by reviewing patient-reported Global Treatment Improvement scale scores after the 4-week treatment period. Aim 2: To identify the impact on overall and vulvar pain by calculating the difference between average pre- and post-treatment PGIC, NRS, CSI and VPAQ scores. Aim 3: To identify adverse effects that patients may experience during treatment to better understand the safety profile of this medication. Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\] * Attend a baseline clinic visit and complete PGIC, NRS, VPAQ, and CSI questionnaires * Take 4.5 mg LDN once daily for 4 weeks * Discontinue LDN and contact the health care team immediately in the event of adverse effects * Attend a follow up appointment 4 weeks after medication initiation

Timeline

Start

2027-01-01

Primary completion

2027-07-01

Completion

2028-01-01

Publications

• Background Hatfield E, Phillips K, Swidan S, Ashman L. Use of low-dose naltrexone in the management of chronic pain conditions: A systematic review. J Am Dent Assoc. 2020 Dec;151(12):891-902.e1. doi: 10.1016/j.adaj.2020.08.019.
• Background Rupp A, Young E, Chadwick AL. Low-dose naltrexone's utility for non-cancer centralized pain conditions: a scoping review. Pain Med. 2023 Nov 2;24(11):1270-1281. doi: 10.1093/pm/pnad074.
• Background McKenzie-Brown AM, Boorman DW, Ibanez KR, Agwu E, Singh V. Low-Dose Naltrexone (LDN) for Chronic Pain at a Single Institution: A Case Series. J Pain Res. 2023 Jun 14;16:1993-1998. doi: 10.2147/JPR.S389957. eCollection 2023.
• Background Levesque A, Riant T, Labat JJ, Ploteau S. Use of High-Concentration Capsaicin Patch for the Treatment of Pelvic Pain: Observational Study of 60 Inpatients. Pain Physician. 2017 Jan-Feb;20(1):E161-E167.
• Background Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
• Background Committee Opinion No 673 Summary: Persistent Vulvar Pain. Obstet Gynecol. 2016 Sep;128(3):676-677. doi: 10.1097/AOG.0000000000001639.
• Background Sullender RT, Silverstein RG, Goodwin DM, McClurg AB, Carey ET. Low-dose naltrexone as a treatment for vulvodynia: A case series. Case Rep Womens Health. 2024 Dec 13;45:e00677. doi: 10.1016/j.crwh.2024.e00677. eCollection 2025 Mar.
• Background Younger J, Parkitny L, McLain D. The use of low-dose naltrexone (LDN) as a novel anti-inflammatory treatment for chronic pain. Clin Rheumatol. 2014 Apr;33(4):451-9. doi: 10.1007/s10067-014-2517-2. Epub 2014 Feb 15.
• Background Metyas S, Chen CL, Yeter K, Solyman J, Arkfeld DG. Low Dose Naltrexone in the Treatment of Fibromyalgia. Curr Rheumatol Rev. 2018;14(2):177-180. doi: 10.2174/1573397113666170321120329.
• Background Goldstein AT, Burrows L. Vulvodynia. J Sex Med. 2008 Jan;5(1):5-14; quiz 15. doi: 10.1111/j.1743-6109.2007.00679.x.
• Background Harlow BL, Kunitz CG, Nguyen RH, Rydell SA, Turner RM, MacLehose RF. Prevalence of symptoms consistent with a diagnosis of vulvodynia: population-based estimates from 2 geographic regions. Am J Obstet Gynecol. 2014 Jan;210(1):40.e1-8. doi: 10.1016/j.ajog.2013.09.033. Epub 2013 Sep 28.
• Background Friedrich EG Jr. Vulvar vestibulitis syndrome. J Reprod Med. 1987 Feb;32(2):110-4.
• Background Ventolini G. Measuring treatment outcomes in women with vulvodynia. J Clin Med Res. 2011 Apr 4;3(2):59-64. doi: 10.4021/jocmr526w.

Drugs

Indications