Trial reportMenopause (New York, N.Y.)2019
Efficacy and safety of ospemifene in postmenopausal women with moderate-to-severe vaginal dryness: a phase 3, randomized, double-blind, placebo-controlled, multicenter trial.
Trial report in Menopause (New York, N.Y.), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 2 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
25 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Hormonal Treatments and Vaginal Moisturizers for Genitourinary Syndrome of Menopause : A Systematic Review.Annals of internal medicine · 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
- Effects of ospemifene on genitourinary health assessed by prospective vulvar-vestibular photography and vaginal/vulvar health indices.Menopause (New York, N.Y.) · 2019Trial
- A comprehensive model for gynecologic cancer patients' survivorship care.Gynecologic oncology reports · 2026Review
- Reproductive Longevity: Innovative Approaches Beyond Hormone Replacement Therapy.Medicina (Kaunas, Lithuania) · 2026Review
- Treatment Strategies for Cutaneous and Oral Mucosal Side Effects of Oncological Treatment in Breast Cancer: A Comprehensive Review.Biomedicines · 2025Review
- Clinical practice guidelines: sexual dysfunction in gynecological cancer patients.Sexual medicine · 2025Review
- Vaginal health in breast cancer survivors: a practical clinical approach.Therapeutic advances in medical oncology · 2025Review
- Comparison of topical estrogen and platelet-rich plasma injections in the treatment of postmenopausal vaginal atrophy.Frontiers in medicine · 2025Article
- Treatment of Genitourinary Syndrome of Menopause in Breast Cancer and Gynecologic Cancer Survivors: Retrospective Analysis of Efficacy and Safety of Vaginal Estriol, Vaginal Dehydroepiandrosterone and Ospemifene.Journal of menopausal medicine · 2024Article
- Update on Genitourinary Syndrome of Menopause: A Scoping Review of a Tailored Treatment-Based Approach.Life (Basel, Switzerland) · 2024Article
- Managing sexual health challenges in breast cancer survivors: A comprehensive review.Breast (Edinburgh, Scotland) · 2024Review
- Gynecologic Care of Black Breast Cancer Survivors.Current breast cancer reports · 2024Article
- Hormone therapy for sexual function in perimenopausal and postmenopausal women.The Cochrane database of systematic reviews · 2023Review
- An online survey on coping methods for genitourinary syndrome of menopause, including vulvovaginal atrophy, among Japanese women and their satisfaction levels.BMC women's health · 2023Article
- Hyaluronic Acid: A Valid Therapeutic Option for Early Management of Genitourinary Syndrome of Menopause in Cancer Survivors?Healthcare (Basel, Switzerland) · 2022Review
- Early Effect of 0.005% Estriol Vaginal Gel on Symptoms and Signs of Vulvovaginal Atrophy.Journal of menopausal medicine · 2022Article
- Risk of venous thromboembolism among women receiving ospemifene: a comparative observational study.Therapeutic advances in drug safety · 2022Article
- 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: case studies with bone marker profiles.Drugs in context · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the safety and efficacy of ospemifene for the treatment of moderate to severe vaginal dryness in postmenopausal women with vulvovaginal atrophy (VVA).
methodsThis 12-week, multicenter, double-blind phase 3 study randomized postmenopausal women (aged 40-80 years) with VVA and moderate to severe vaginal dryness as their most bothersome symptom to daily oral ospemifene 60 mg or placebo. Coprimary efficacy endpoints included changes from baseline to week 12 in percentages of vaginal parabasal and superficial cells, vaginal pH, and vaginal dryness severity with ospemifene versus placebo; other secondary endpoints were evaluated (weeks 4, 8, and 12). Safety was assessed by treatment-emergent adverse events (TEAEs) and endometrial biopsies.
resultsWomen (n = 631; ospemifene [n = 316], placebo [n = 315]) had a mean age of 59.8 years, a mean body mass index of 27.2 kg/m, and most were white. Ospemifene significantly improved (P < 0.0001) the percentages of parabasal and superficial cells, vaginal pH, and severity of vaginal dryness severity compared with placebo at week 12; significant between-group differences were noted by week 4. Secondary endpoints of dyspareunia (P < 0.001), maturation value (P < 0.0001), and the Female Sexual Function Index (P < 0.05) also significantly improved with ospemifene versus placebo at week 12. Significantly more women responded (31.5% vs 6.0%; P < 0.0001) or were satisfied (49.2% vs 33.8%; P = 0.0007) with ospemifene versus placebo at week 12. No unexpected TEAEs, treatment-related serious TEAEs, thrombotic events, or endometrial hyperplasia or carcinoma were observed.
conclusionsOspemifene was effective and well tolerated for the treatment of moderate-to-severe vaginal dryness in postmenopausal women with VVA.
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