Improvements to the Vulva, Vestibule, Urethral Meatus, and Vagina in Women Treated With Ospemifene for Moderate to Severe Dyspareunia: A Prospective Vulvoscopic Pilot Study

Abstract

IntroductionOspemifene, an oral selective estrogen receptor modulator approved for the treatment of mild to moderate dyspareunia from menopause, has been shown to moderate sexual pain and vaginal epithelial cell characteristics. However, no prospective vulvoscopic studies have been performed.AimTo examine, in menopausal women taking ospemifene 60 mg daily, changes to the vulva, vestibule, urethral meatus, and vaginal region over 20 weeks using vulvoscopy in a prospective open-label pilot study.MethodsVulvoscopic photographs taken at screening and the end of therapy assessed for changes in the appearance of the vulva, vestibule, urethral meatus, and vagina rated by a single reviewer using a 10-parameter Likert rating scale, the Vulvoscopic Genital Tissue Appearance Scale (VGTA). In addition, the cotton-tipped swab test and subject diary scores were assessed over the 20-week treatment period and compared before and after the intervention using Wilcoxon signed-rank test.Main Outcome MeasureChanges in VGTA score from baseline to end of study.Results8 subjects (age = 59 ± 4.7 years) completed all visits and were included in the analysis of vulvoscopic photographs (n = 258). There were significant changes during the study period for urethral meatal prominence, introital stenosis, vestibular pallor, vestibular erythema, mucosal moisture, vaginal rugation, and anterior wall prominence (P < .05). Total pain score during cotton-tipped swab testing decreased from 11 (interquartile range = 10–16) before the intervention to 1 (interquartile range = 0–3) at the end of the study. Quantitative diary analysis indicated an increase in the number of sexual events, decrease in rates of pain during foreplay and intercourse, and decrease in use of lubricant at study completion (P < .05).ConclusionsOspemifene 60 mg daily for 20 weeks showed improvement in physical examination findings in this prospective study of menopausal women with dyspareunia, as documented on vulvoscopic photography. These changes were consistent with improvements in subject-reported pain and sexual function.Goldstein SW, Winter AG, Goldstein I. Improvements to the Vulva, Vestibule, Urethral Meatus, and Vagina in Women Treated With Ospemifene for Moderate to Severe Dyspareunia: A Prospective Vulvoscopic Pilot Study. Sex Med 2018;6:154–161.

Ospemifene for the treatment of menopausal vaginal dryness, a symptom of the genitourinary syndrome of menopause

“…Total VGTAS score improved (decreased) significantly from baseline to week 20 (from 17.5 to 9.5; p < 0.012), as did 7 of 10 tissues (all, p < 0.05). Tissue improvements were also reflected in reduced pain score on cotton-tipped swab test (from 12.9 to 1.9; p = 0.011) and greater proportions of women reporting decreases in dryness and dyspareunia (both, p < 0.02) [53].…”

“…A recent single-arm, open-label pilot study used vulvoscopy to explore the effect of ospemifene for 20 weeks on vulvar and vaginal tissues of 8 postmenopausal women [53]. Women were aged 21-80 years (mean 59 years), with BMI <37 kg/m 2 , moderate to severe dyspareunia, and moderate to severe pain on cottontipped swab testing [53].…”

“…A recent single-arm, open-label pilot study used vulvoscopy to explore the effect of ospemifene for 20 weeks on vulvar and vaginal tissues of 8 postmenopausal women [53]. Women were aged 21-80 years (mean 59 years), with BMI <37 kg/m 2 , moderate to severe dyspareunia, and moderate to severe pain on cottontipped swab testing [53]. Photographs at baseline (n = 118) and end of study (n = 140) were examined with the Vulvoscopic Genital Tissue Appearance Scale (VGTAS; unvalidated 4-point scale), which includes changes in 10 tissues (labia majora, labia minora, clitoris, urethral meatus, introitus, vestibular pallor, vestibular erythema, vestibular moisture, vaginal rugae, and anterior vaginal wall; maximum score 30) [53].…”

“…Women were aged 21-80 years (mean 59 years), with BMI <37 kg/m 2 , moderate to severe dyspareunia, and moderate to severe pain on cottontipped swab testing [53]. Photographs at baseline (n = 118) and end of study (n = 140) were examined with the Vulvoscopic Genital Tissue Appearance Scale (VGTAS; unvalidated 4-point scale), which includes changes in 10 tissues (labia majora, labia minora, clitoris, urethral meatus, introitus, vestibular pallor, vestibular erythema, vestibular moisture, vaginal rugae, and anterior vaginal wall; maximum score 30) [53]. Total VGTAS score improved (decreased) significantly from baseline to week 20 (from 17.5 to 9.5; p < 0.012), as did 7 of 10 tissues (all, p < 0.05).…”

“…Evidence demonstrates that ospemifene improves vaginal moisture distinct from the effects of lubricants [38,41], as lubricants may provide temporary symptom relief but do not treat the underlying pathophysiology of VVA, and in some cases may cause irritation [2]. Structural improvements were documented in vaginal and vulvar tissues upon visual examination and imaging studies after ospemifene [39,47,[52][53][54][55], and histologic studies demonstrated similar improvements in vulvar and vaginal tissue for epithelial layer thickness, proliferation index, and collagen content [56,57]. Elective use of lubricants during phase 3 trials decreased more over time in ospemifene than in placebo groups, presumably because they were less necessary [38,39,52].…”