Vulvar vestibular effects of ospemifene: a pilot study

Gynecol Endocrinol. 2018 Jul;34(7):631-635. doi: 10.1080/09513590.2018.1427717. Epub 2018 Jan 15.

Abstract

The study aimed to assess the effects of ospemifene on vulvar vestibule in postmenopausal women with vulvar pain and dyspareunia. Fifty-five postmenopausal women used oral ospemifene 60 mg/d for 60 d. Symptoms of dryness, burning, and dyspareunia were evaluated on a 10 cm visual analog scale. Visual examination of the vulvar vestibule was also conducted. Patients also underwent current perception threshold (CPT) testing obtained from the vulvar vestibule. Fifty-five patients (94.6%) completed the treatment. Hot flashes were the most frequent adverse effects, but this led to a discontinuation of therapy in three patients (5.4%). After therapy, there was a statistically significant decrease from the baseline in the mean scores for dryness, burning, and dyspareunia and reduction of vestibular trophic score (baseline value of 11.2-4.2 after the therapy, p ≤ 002) and cotton swab test scores (2.81 compared with 1.25, p = .001). There was a difference in CPT values for all nerve fibers and more consistent for C fibers (-38% of sensitivity). These results confirm the efficacy of ospemifene on postmenopausal vestibular symptoms and signs; moreover, the drug was effective in normalizing vestibular innervation sensitivity.

Keywords: Dyspareunia; ospemifene; postmenopausal; vulvar vestibule; vulvodynia.

Publication types

  • Clinical Trial

MeSH terms

  • Administration, Buccal
  • Dyspareunia / complications
  • Dyspareunia / drug therapy*
  • Dyspareunia / epidemiology
  • Dyspareunia / physiopathology
  • Electric Stimulation
  • Female
  • Hot Flashes / chemically induced
  • Hot Flashes / epidemiology
  • Humans
  • Middle Aged
  • Pain Measurement / methods
  • Pain Perception / drug effects
  • Pilot Projects
  • Postmenopause / drug effects
  • Postmenopause / physiology
  • Syndrome
  • Tamoxifen / administration & dosage
  • Tamoxifen / adverse effects
  • Tamoxifen / analogs & derivatives*
  • Vulva / drug effects
  • Vulva / physiopathology
  • Vulvar Vestibulitis / complications
  • Vulvar Vestibulitis / drug therapy*
  • Vulvar Vestibulitis / epidemiology
  • Vulvar Vestibulitis / physiopathology
  • Vulvodynia / complications
  • Vulvodynia / drug therapy*
  • Vulvodynia / epidemiology
  • Vulvodynia / physiopathology

Substances

  • Tamoxifen
  • Ospemifene