Ophena (ospemifene) / Shionogi - LARVOL DELTA

Case-Based Perspectives on the Management of Genitourinary Syndrome of Menopause. (PubMed, Clin Pract) - "Treating GSM improves vaginal, sexual and urinary outcomes and quality of life of women. Clinicians need to proactively screen for GSM and offer evidence-based treatment options. The treatment decisions in breast cancer survivors are nuanced, requiring a shared-decision approach."

Journal • Review • Breast Cancer • Gynecology • Infectious Disease • Nephrology • Oncology • Sexual Disorders • Solid Tumor • Vaginal Atrophy • Vaginitis • Women's Health

A computationally informed framework for lipid-based formulation developability: Integrating predictive models with case studies. (PubMed, J Pharm Sci) - "A database of >200 FDA-approved oral drugs (2010-2023) was screened through the computational framework, and four case studies (dapagliflozin, mavacamten, ospemifene, flibanserin) illustrate the framework's ability to classify risk and guide formulation decisions. This integrated approach enables rapid, data-driven formulation decisions, reducing reliance on trial-and-error methods and supporting early-stage development of PWSDs. By coupling computational predictions with targeted experimental validation, the framework offers a practical roadmap for accelerating LBF adoption and improving R&D efficiency."

Journal

Long-term effectiveness of ospemifene in treatment of moderate to severe vulvo-vaginal atrophy in women with and without history of breast cancer: the PatiEnt satisfactiON studY (PEONY) study. (ISGE 2026) - "The PEONY study demonstrated sustained 12-month efficacy of ospemifene in reducing VVA symptoms and improving quality of life, with additional benefits on urinary complaints. Findings support ospemifene as a long-term therapy for moderate-severe VVA, regardless of BC history."

Clinical • Breast Cancer • Gynecology • Infectious Disease • Nephrology • Oncology • Pruritus • Solid Tumor • Vaginal Atrophy • Women's Health

Menopause after breast cancer (ISGE 2026) - "For GSM, non-hormonal lubricants and hyaluronic acid are the first line options, however in non-responders low-doses vaginal estrogens, vaginal prasterone and oral ospemifene can be considered...Bisphosphonate and denosumab are pharmacological options to prevent bone loss and fractures in BCS. Conclusions The toxicities caused by AET, can become disabling and induce the patient to interrupt the therapy prematurely. Focusing on menopausal symptoms and QoL in BCS is an essential part of cancer treatment and their treatment should be individualized."

Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Musculoskeletal Diseases • Oncology • Solid Tumor • Women's Health

Treating Genitourinary Syndrome of Menopause in Postmenopausal Women with a History of Breast Cancer. (PubMed, Drugs Aging) - "A stepwise, symptom-driven treatment model is recommended-beginning with non-hormonal options and advancing to local vaginal therapies or ospemifene when appropriate...Local estrogen is generally safer in tamoxifen users, but caution is warranted with aromatase inhibitors due to potential systemic absorption. In patients with estrogen receptor-negative disease, local hormone use may be considered but requires careful risk-benefit evaluation and shared decision making is essential. Until long-term safety data emerge, management should remain individualized, evidence-based, and multidisciplinary."

Journal • Review • Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Women's Health • ER

Treatment of vulvovaginal atrophy is associated with high levels of satisfaction and improves symptom severity and patient-reported outcomes: 12-month results of the PatieEnt satisfactiON studY (PEONY). (PubMed, Menopause) - "The PatiEnt satisfactiON studY (PEONY) documents the high effectiveness, satisfaction, and persistence after 12 months with LET or ospemifene in women with VVA."

Journal • Gynecology • Vaginal Atrophy • Women's Health

Treatment patterns for genitourinary syndrome of menopause: a TriNetX analysis. (PubMed, Can J Urol) - "Most women diagnosed with GSM did not receive treatment. Among those treated, topical estrogen was the predominant therapy. Newer therapies were underutilized, though it is unclear whether this is due to provider familiarity, patient preference, or access. Further research is warranted to elucidate the underlying reasons for undertreatment in this population."

Journal • Gynecology • Vaginal Atrophy • Vaginitis • Women's Health

Hormone replacement therapy in gynecologic cancer: oncologic safety and alternative therapies. (PubMed, Int J Gynecol Cancer) - "Hormonal therapies for genitourinary syndrome of menopause, including vaginal estrogens, ospemifene, and vaginal dehydroepiandrosterone, have demonstrated efficacy in relieving symptoms and improving urogenital health...Non-hormonal therapies proven effective for managing vasomotor symptoms and sleep disturbances include cognitive behavioral therapy, clinical hypnosis, gabapentin, fezolinetant, and selective serotonin or serotonin-norepinephrine re-uptake inhibitors. Personalized treatment decisions should be guided by cancer type, recurrence risk, patient preferences, and quality-of-life considerations. It is essential to balance oncologic safety with symptom relief and long-term health outcomes in this growing population of cancer survivors."

Journal • Review • Cervical Cancer • CNS Disorders • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Sarcoma • Sleep Disorder • Solid Tumor • Uterine Cancer • Vaginal Cancer • Women's Health

Ospemifene, a Selective Estrogen Receptor Modulator, Enhances Oligodendrocyte Myelination and Preserves Neurofunctions Against Injuries. (PubMed, J Neurochem) - "This treatment increased newly generated myelin sheaths in the lesions, confirming its promyelinogenesis effect. Together, our findings suggest that ospemifene is a promising treatment option for demyelinating diseases."

Journal • CNS Disorders • Immunology • Multiple Sclerosis • Solid Tumor

EROS: Effects of Ospemifene on Brain Activation Patterns in Women With Sexual Interest-arousal Disorders (clinicaltrials.gov) - P4 | N=25 | Completed | Sponsor: Hospital Clinic of Barcelona | Recruiting ➔ Completed

Trial completion • Sexual Disorders • Women's Health

Quality of life and Satisfaction With Ospemifene for Treating Vulvovaginal Atrophy in Breast Cancer Survivors: Six-Month Results From the PatiEnt SatisfactiON StudY (PEONY). (PubMed, Clin Breast Cancer) - "Ospemifene is effective and well-tolerated for treating moderate to severe VVA of women with history of BC. However, a comprehensive and multidisciplinary approach is needed to improve sexual function of BC survivors treated for VVA."

Clinical • HEOR • Journal • Breast Cancer • Infectious Disease • Nephrology • Oncology • Pain • Solid Tumor • Vaginal Atrophy • Women's Health

Treatment of Menopausal Symptoms When Hormone Therapy Is Contraindicated. (PubMed, Semin Reprod Med) - "This review explores alternative nonhormonal treatments, including pharmacological options like selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, gabapentin, clonidine, and neurokinin receptor antagonists (e.g., fezolinetant), alongside nonpharmacological approaches such as lifestyle modifications, cognitive-behavioral therapy, and acupuncture. GSM management includes therapies such as vaginal estrogens, prasterone, and ospemifene, with tailored approaches necessary for cancer survivors. Emphasis is placed on individualized care, better patient education, and continued research into the safety and efficacy of these therapies to improve the QoL for postmenopausal women."

Journal • Cardiovascular • Oncology • Women's Health

Comparison of estrogens and selective estrogen receptor modulators (SERMs) used for menopausal hormone therapy. (PubMed, Menopause) - "Commonly used SERMs include tamoxifen, raloxifene, ospemifene, lasofoxifene, and bazedoxifene. Lastly, E4 has emerged as a novel estrogen with beneficial effects on VMS, GSM, and bone, and neutral effects on the breast and hemostatic factors. A personalized approach, based on each woman's biological profile, is recommended to guide the choice of MHT."

Clinical • Journal • Review • Breast Cancer • Cardiovascular • Hormone Receptor Breast Cancer • Oncology • Rheumatology • Solid Tumor • Venous Thromboembolism • Women's Health

Ospemifene May Provide Better Results Than Other Approaches to Treat Some Vaginal Symptoms of Menopause. (PubMed, Am Fam Physician) - No abstract available

Journal

Beyond hormones: 3PM approach to vaginal microbiota dynamics in postmenopausal women. (PubMed, EPMA J) - "The analysis evaluated microbiota-based risk stratification strategies for vaginal dysbiosis and demonstrated the effectiveness of both hormonal interventions (systemic/local estrogen, tibolone, ospemifene) and non-hormonal alternatives (probiotics, energy-based devices, pessary) in normalizing microbiota composition and improving vaginal health. Developing standardized yet personalized protocols to restore a balanced vaginal microbiome could help alleviate menopause-related symptoms. Advancing microbiota-based personalized therapeutic approaches is crucial to enhancing the quality of life for postmenopausal women through targeted and individualized vaginal health management."

Journal • Review • Endocrine Disorders • Women's Health

State of the art in menopause: current best practice approaches from the IMS World Congress 2024, Melbourne. (PubMed, Climacteric) - "Addressing genitourinary symptoms and sexual health, vaginal estrogen therapy is confirmed as a safe and effective option with vaginal dehydroepiandrosterone (DHEA) and oral ospemifene as suitable alternatives, while testosterone therapy offers benefits for hypoactive sexual desire disorder in postmenopausal women...Cancer risk management stressed the need for a multidisciplinary approach to risk reduction beginning with lifestyle modification, and with non-hormonal therapies prioritized for symptomatic treatment of menopausal symptoms in those with hormone-sensitive cancers. Lastly, perimenopause management highlighted comprehensive approaches integrating symptom relief and contraceptive needs."

Journal • Cardiovascular • CNS Disorders • Depression • Oncology • Osteoporosis • Psychiatry • Rheumatology • Sexual Disorders • Sleep Disorder

Treating VVA improves symptom severity and patient-reported outcomes: 6-month PEONY results. (PubMed, Climacteric) - "DIVA and FSDS-R scores significantly improved in both groups. PEONY underlines the importance of proactively treating VVA with LET or ospemifene to alleviate the burden associated with the disease."

Journal • Breast Cancer • Gynecology • Oncology • Solid Tumor • Vaginal Atrophy • Women's Health

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. (PubMed, J Menopausal Med) - "Vaginal estriol, vaginal DHEA, and ospemifene were effective in improving symptoms of GSM in cancer survivors and were not associated with cancer recurrence over the 6-month follow-up. Ospemifene was more effective than local hormones in treating dyspareunia."

Journal • Retrospective data • Breast Cancer • Cervical Cancer • Gynecologic Cancers • Oncology • Pain • Solid Tumor • Vulvar Cancer • Women's Health

Review of current and emerging estrogen receptor agonists for vaginal atrophy. (PubMed, Expert Opin Pharmacother) - "Alternatives like selective estrogen receptor modulators (SERMs) such as prasterone and ospemifene show promise but need more long-term safety data. Emerging options like E3 and E4 demonstrate efficacy and safety in low doses. Future treatments will emphasize convenience and adherence, making timely diagnosis and management of VVA routine in women's health care."

Journal • Review • Endocrine Disorders • Infectious Disease • Nephrology • Vaginal Atrophy • Women's Health

Update on Genitourinary Syndrome of Menopause: A Scoping Review of a Tailored Treatment-Based Approach. (PubMed, Life (Basel)) - "First-line treatments typically include lubricants and moisturizers for short-term symptom relief, while unresolved or severe cases may warrant hormonal treatment. Topical hormonal treatments often have fewer side effects than systemic alternatives. Special attention is given to selective estrogen receptor modulators like ospemifene and steroid hormones like dehydroepiandrosterone (DHEA), which have shown beneficial effects on GSM symptoms. Moreover, innovative therapeutic approaches, such as laser treatment, are discussed in the context of their efficacy and accessibility. The safety of GSM hormonal therapy in women with a history or risk of cancer is also addressed, noting the need for more definitive research in this area. While there is a growing demand for tailored therapy, this scoping review emphasizes the importance of effective communication and counseling to allow women to make informed decisions about their treatment. Overall, this review underscores the need..."

Journal • Review • Infectious Disease • Oncology • Urinary Incontinence • Urology • Vaginal Atrophy • Women's Health

Midurethral Sling in the Treatment of Mixed Urinary Incontinence: A Literature Review of Functional Outcomes and Associated Factors. (PubMed, Fr J Urol) - "MUS is an effective treatment for MUI. Further research is needed to better understand the potential benefits of concurrent treatments and to develop models that can predict outcomes and assist physicians in shared decision making about how to approach the management of MUI."

Journal • Review • Urinary Incontinence • Urology

Effect of Vaginal Laser and Topical Therapies on Vulvovaginal Atrophy Symptoms in Breast Cancer Patients: A Systematic Review and Meta-Analysis. (PubMed, J Clin Med) - " We performed a systematic review and meta-analysis to identify effective treatment options for VVA, including topical estrogen, systemic hormone therapy, vaginal DHEA, ospemifene, and non-hormonal methods like intravaginal laser therapy, moisturizers, and lubricants... Intravaginal laser therapy is an effective treatment for VVA symptoms in breast cancer survivors, particularly in improving the Vaginal Health Index and reducing dyspareunia. Despite the strengths of the study, variability among studies, lack of RCT-s and data limitations, especially on long-term effects, present challenges."

Journal • Retrospective data • Review • Breast Cancer • Oncology • Solid Tumor • Vaginal Atrophy • Women's Health

Treatments for genitourinary syndrome of menopause: a systematic review of hormonal interventions and vaginal moisturizers (NAMS 2024) - "Vaginal testosterone, systemic DHEA, vaginal oxytocin, and oral raloxifene or bazedoxifene showed no benefit (low to moderate COE) or had uncertain effects (very low COE). Vaginal estrogen, vaginal DHEA, oral ospemifene, and vaginal moisturizers may improve some GSM symptoms. Little long-term data exists on efficacy, comparative effectiveness, tolerability, and safety of GSM treatments. Future research would be strengthened by standard definitions of symptoms and uniform diagnostic criteria for GSM, a common set of validated outcome measures and reporting standards, comparative effectiveness trials, and long-term follow-up for efficacy, tolerability, and safety."

Review • Women's Health

Hormonal Treatments and Vaginal Moisturizers for Genitourinary Syndrome of Menopause : A Systematic Review. (PubMed, Ann Intern Med) - "Compared with placebo, vaginal dehydroepiandrosterone (DHEA) may improve dryness, dyspareunia, and distress, bother, or interference from genitourinary symptoms; oral ospemifene may improve dryness, dyspareunia, and treatment satisfaction; and vaginal moisturizers may improve dryness (all low COE). Vaginal testosterone, systemic DHEA, vaginal oxytocin, and oral raloxifene or bazedoxifene may provide no benefit (low COE) or had uncertain effects (very low COE)...Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute. (PROSPERO: CRD42023400684)."

Journal • Review • Oncology • Vaginal Cancer • Women's Health

Ospemifene and vulvovaginal atrophy: an update of the clinical profile for post-menopausal women. (PubMed, Expert Opin Pharmacother) - "Seven RCTs involved nearly 5,000 patients, 10/18 prospective observational studies 563, and six retrospective analyses 356,439.Evidence of OSP treatment in PMW with GSM relies on RCTs and remarkable real-world data. The studies showcased the high clinical response to symptoms, the favorable safety profile of OSP with very few adverse events, a neutral impact on the endometrium, breast, bone, and thrombosis, and the possible improvement of cardiovascular risk factors."

Journal • Review • Breast Cancer • Cardiovascular • Hematological Disorders • Metabolic Disorders • Oncology • Solid Tumor • Thrombosis • Vaginal Atrophy • Women's Health