Trial reportClimacteric : the journal of the International Menopause Society2015
Female sexual function improved with ospemifene in postmenopausal women with vulvar and vaginal atrophy: results of a randomized, placebo-controlled trial.
Trial report in Climacteric : the journal of the International Menopause Society, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
26 citing papers in PubMed, 5 syntheses or guidelines pooled it, 143 citations in OpenAlex.
- Hormonal Treatments and Vaginal Moisturizers for Genitourinary Syndrome of Menopause : A Systematic Review.Annals of internal medicine · 2024Pooled it
- The effects of various therapies on vulvovaginal atrophy and quality of life in gynecological cancer patients: a systematic review.Archives of gynecology and obstetrics · 2024Pooled it
- Efficacy of Hormonal and Nonhormonal Approaches to Vaginal Atrophy and Sexual Dysfunctions in Postmenopausal Women: A Systematic Review.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2022Pooled it
- Cardiovascular Changes in Menopause.Current cardiology reviews · 2021Pooled it
- Chronic oxytocin administration as a tool for investigation and treatment: A cross-disciplinary systematic review.Neuroscience and biobehavioral reviews · 2020Pooled it
- Effects of vaginal administration of conjugated estrogens tablet on sexual function in postmenopausal women with sexual dysfunction: a double-blind, randomized, placebo-controlled trial.BMC women's health · 2020Trial
- Diode Laser and Radiofrequency for Genitourinary Syndrome of Menopause: A Comparative Analysis.Healthcare (Basel, Switzerland) · 2026Article
- Treatment patterns for genitourinary syndrome of menopause: a TriNetX analysis.The Canadian journal of urology · 2025Article
- The Canadian Breast Cancer Symposium 2023 Meeting Report.Current oncology (Toronto, Ont.) · 2024Article
- Hormone therapy for sexual function in perimenopausal and postmenopausal women.The Cochrane database of systematic reviews · 2023Review
- The Current Strategy in Hormonal and Non-Hormonal Therapies in Menopause-A Comprehensive Review.Life (Basel, Switzerland) · 2023Review
- Management of genitourinary syndrome of menopause in breast cancer survivors: An update.World journal of clinical oncology · 2022Review
- Toward a better measure of midlife sexual function: pooled analyses in nearly 1,000 women participating in MsFLASH randomized trials.Menopause (New York, N.Y.) · 2022Article
- The effectiveness of reality therapy on sexual satisfaction and marital intimacy of infertile women.Journal of education and health promotion · 2022Article
- The 2020 Menopausal Hormone Therapy Guidelines.Journal of menopausal medicine · 2020Review
- 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
- Experience with ospemifene in patients with vulvar and vaginal atrophy and associated sexual dysfunction: case studies.Drugs in context · 2020Article
- Female Sexual Function at Midlife and Beyond.Obstetrics and gynecology clinics of North America · 2018Review
- An international Urogynecological association (IUGA)/international continence society (ICS) joint report on the terminology for the assessment of sexual health of women with pelvic floor dysfunction.International urogynecology journal · 2018Article
- Therapeutic Approaches to Atrophic Vaginitis in Postmenopausal Women: A Systematic Review with a Network Meta-analysis of Randomized Controlled Trials.Journal of menopausal medicine · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOspemifene is a non-estrogen, tissue selective estrogen receptor agonist/antagonist, or selective estrogen receptor modulator, recently approved for the treatment of dyspareunia, a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Postmenopausal dyspareunia is often associated with female sexual dysfunction (FSD). In this report, we present data that demonstrate the effect of ospemifene 60 mg/day on FSD assessed by the Female Sexual Function Index (FSFI), a widely used tool with six domains (Arousal, Desire, Orgasm, Lubrication, Satisfaction, and Pain).
methodsA phase-3, randomized, double-blind, 12-week trial (n = 919) compared the efficacy and safety of oral ospemifene 60 mg/day vs. placebo in postmenopausal women with VVA in two strata based on self-reported, most bothersome symptom of either dyspareunia or dryness. Primary data were published previously. We report herein pre-specified secondary efficacy endpoints analyses, including changes from baseline to Weeks 4 and 12 for FSFI total and domain scores as well as serum hormone levels.
resultsOspemifene 60 mg/day demonstrated a significantly greater FSFI total score improvement vs. placebo at Week 4 (p < 0.001). Improvement in FSFI scores continued to Week 12 (p < 0.001). At Week 4, the FSFI domains of Sexual Pain, Arousal, and Desire were significantly improved with ospemifene vs. placebo; at Week 12, improvements in all domains were significant (p < 0.05). Changes in serum hormones were minor and uncorrelated with changes in sexual functioning.
conclusionIn a large, randomized, double-blind, placebo-controlled trial, ospemifene 60 mg/day significantly improved FSD in women with VVA. Consistent effects across FSFI domains were observed.
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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.