Trial reportClimacteric : the journal of the International Menopause Society2014
Ospemifene 12-month safety and efficacy in postmenopausal women with vulvar and vaginal atrophy.
Trial report in Climacteric : the journal of the International Menopause Society, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 31 papers, 3 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.
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
Thermal Treatment of Vulvo-vaginal Atrophy (VVA) Using Novel Low-energy Dynamic Quadripolar Radio-Frequency (DQRF)
Who cites it
31 citing papers in PubMed, 3 syntheses or guidelines pooled it, 123 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
- Survivorship, Version 2.2017, NCCN Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN · 2017Guideline
- Efficacy and safety of ospemifene in postmenopausal women with moderate-to-severe vaginal dryness: a phase 3, randomized, double-blind, placebo-controlled, multicenter trial.Menopause (New York, N.Y.) · 2019Trial
- Overall Safety of Ospemifene in Postmenopausal Women from Placebo-Controlled Phase 2 and 3 Trials.Journal of women's health (2002) · 2018Trial
- Ospemifene's effects on lipids and coagulation factors: a post hoc analysis of phase 2 and 3 clinical trial data.Menopause (New York, N.Y.) · 2017Trial
- Impact of Ospemifene on Quality of Life and Sexual Function in Young Survivors of Cervical Cancer: A Prospective Study.BioMed research international · 2017Trial
- Female sexual function improved with ospemifene in postmenopausal women with vulvar and vaginal atrophy: results of a randomized, placebo-controlled trial.Climacteric : the journal of the International Menopause Society · 2015Trial
- The clinical relevance of the effect of ospemifene on symptoms of vulvar and vaginal atrophy.Climacteric : the journal of the International Menopause Society · 2015Trial
- Endometrial safety of ospemifene: results of the phase 2/3 clinical development program.Menopause (New York, N.Y.) · 2015Trial
- Evidence-based recommendations for advancing the chronic pelvic pain syndrome management by the paradigm change from reactive symptom suppression to proactive 3PM-guided patient-centered care.The EPMA journal · 2026Review
- Long-term effects of ospemifene on densitometric and bone metabolism biomarkers in postmenopausal women reporting Vulvar and Vaginal Atrophy (VVA).BMC women's health · 2026Article
- Treating Genitourinary Syndrome of Menopause in Postmenopausal Women with a History of Breast Cancer.Drugs & aging · 2026Review
- Sexual function in chronic illness and cancer perspectives of the patient, partner, and healthcare provider; innovations; and updates: recommendations from the Fifth International Consultation on Sexual Medicine (ICSM 2024).Sexual medicine reviews · 2026Review
- Novel bioactive compounds in the treatment of osteoporosis: chemistry-driven discovery from preclinical validation to clinical translation.Frontiers in chemistry · 2026Review
- Ospemifene for Genitourinary Syndrome of Menopause: Patient Selection.International journal of women's health · 2024Review
- Clinical guidelines for managing menopausal symptoms in women with (a history of) breast cancer.Facts, views & vision in ObGyn · 2023Article
- Treating and Managing Urinary Incontinence: Evolving and Potential Multicomponent Medical and Lifestyle Interventions.Research and reports in urology · 2023Review
- Effect of Ospemifene on Densitometric and Plasma Bone Metabolism Biomarkers in Postmenopausal Women Reporting Vulvar and Vaginal Atrophy (VVA).Journal of clinical medicine · 2022Article
- Treating menopause - MHT and beyond.Nature reviews. Endocrinology · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 5 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveAssessment of 12-month safety of ospemifene 60 mg/day for treatment of postmenopausal women with vulvar and vaginal atrophy (VVA).
methodsIn this 52-week, randomized, double-blind, placebo-controlled, parallel-group study, women 40-80 years with VVA and an intact uterus were randomized 6 : 1 to ospemifene 60 mg/day or placebo. The primary objective was 12-month safety, particularly endometrial; 12-week efficacy was assessed. Safety assessments included endometrial histology and thickness, and breast and gynecological examinations. Efficacy evaluations included changes from baseline to week 12 in percentage of superficial and parabasal cells and vaginal pH.
resultsOf 426 randomized subjects, 81.9% (n = 349) completed the study with adverse events the most common reason for discontinuation (ospemifene 9.5%; placebo 3.9%). Most (88%) treatment-emergent adverse events with ospemifene were considered mild or moderate. Three cases (1.0%) of active proliferation were observed in the ospemifene group. For one, active proliferation was seen at end of study week 52, and diagnosed as simple hyperplasia without atypia on follow-up biopsy 3 months after the last dose. This subsequently resolved with progestogen treatment and dilatation and curettage. In six subjects (five ospemifene (1.4%), one placebo (1.6%)) endometrial polyps were found (histopathology); however, only one (ospemifene) was confirmed as a true polyp during additional expert review. Endometrial histology showed no evidence of carcinoma. Statistically significant improvements were seen for all primary and secondary efficacy measures and were sustained through week 52 with ospemifene vs. placebo.
conclusionsThe findings of this 52-week study confirm the tolerance and efficacy of oral ospemifene previously reported in short- and long-term studies.
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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.