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2018 ; 6
(2
): 154-161
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gab.com Text
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English Wikipedia
Improvements to the Vulva, Vestibule, Urethral Meatus, and Vagina in Women
Treated With Ospemifene for Moderate to Severe Dyspareunia: A Prospective
Vulvoscopic Pilot Study
#MMPMID29678557
Goldstein SW
; Winter AG
; Goldstein I
Sex Med
2018[Jun]; 6
(2
): 154-161
PMID29678557
show ga
INTRODUCTION: Ospemifene, 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. AIM: To 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. METHODS: Vulvoscopic 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 MEASURE: Changes in
VGTA score from baseline to end of study. RESULTS: 8 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).
CONCLUSIONS: Ospemifene 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.