ArticleSexual medicine2018
Improvements to the Vulva, Vestibule, Urethral Meatus, and Vagina in Women Treated With Ospemifene for Moderate to Severe Dyspareunia: A Prospective Vulvoscopic Pilot Study.
Article in Sexual medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02784613 (Open-Label Pilot Prospective Vulvoscopy Photography Study of Visible Changes in the Vulva, Vestibule, Vagina Pre/Post 20 Weeks of Daily Administration 60 Mg Ospemifene in Post-Menopausal Women With Dyspareunia From Vulvar Vaginal Atrophy), which is not on this map. Cited by 7 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Open-Label Pilot Prospective Vulvoscopy Photography Study of Visible Changes in the Vulva, Vestibule, Vagina Pre/Post 20 Weeks of Daily Administration 60 Mg Ospemifene in Post-Menopausal Women With Dyspareunia From Vulvar Vaginal Atrophy
Who cites it
7 citing papers in PubMed, 33 citations in OpenAlex.
- Effects of ospemifene on genitourinary health assessed by prospective vulvar-vestibular photography and vaginal/vulvar health indices.Menopause (New York, N.Y.) · 2019Trial
- Recommendations for the Diagnosis and Treatment of Genitourinary Syndrome of Menopause from the Italian Society of Menopause (SIM) and Italian Society of Gynecology of the Third Age (SIGiTE).Healthcare (Basel, Switzerland) · 2026Review
- Ospemifene for Genitourinary Syndrome of Menopause: Patient Selection.International journal of women's health · 2024Review
- Vestibular tissue changes following administration of intravaginal prasterone: a vulvoscopic open-label pilot study in menopausal women with dyspareunia.Sexual medicine · 2023Article
- Modern management of genitourinary syndrome of menopause.Faculty reviews · 2021Review
- Ospemifene in the Management of Vulvar and Vaginal Atrophy: Focus on the Assessment of Patient Acceptability and Ease of Use.Patient preference and adherence · 2020Review
- Vaginal Health in Menopausal Women.Medicina (Kaunas, Lithuania) · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.