Ophena (ospemifene) / Shionogi - LARVOL DELTA

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

Ospemifene for Genitourinary Syndrome of Menopause: Patient Selection. (PubMed, Int J Womens Health) - "This is particularly the case for breast cancer survivors or women with a significant family history of estrogen-dependent cancers. Hence, tailored treatment plans, considering individual preferences and health circumstances, are essential in optimizing outcomes and improving the overall well-being of affected individuals."

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

Evaluating Genitourinary Syndrome of Menopause Treatment Pathways Utilizing the TriNetX Global Database (AUA 2024) - "A combination of RxNorm and International Classification of Diseases-10 (ICD) codes were used to classify disease and treatment type, which included topical estrogen (RxNorm 4083, 4099)), ospemifene (RxNorm 1370971), prasterone (RxNorm 3143), and hormone replacement therapy (ICD Z79... There are a large number of patients in the TriNetX database diagnosed with GSM. A majority of these patients receive treatment, though a large portion receive no intervention. Patients typically receive a singular therapy, which is overwhelmingly topical estrogen."

Clinical • Gynecology • Infectious Disease • Nephrology • Vaginal Atrophy • Vaginitis • Women's Health

Drugs for menopausal symptoms. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

Vulvovaginal atrophy in women with and without a history of breast cancer: Baseline data from the PatiEnt satisfactiON studY (PEONY) in Italy. (PubMed, Maturitas) - "Moderate/severe vulvovaginal atrophy is a common, often neglected condition with an impact on QoL and sexuality, particularly in women with a history of breast cancer. It is important to alleviate the burden associated with the disease."

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

Novel Advances in the Role of Selective Estrogen Receptor Modulators in Hormonal Replacement Therapy: A Paradigm Shift. (PubMed, Cureus) - "First-generation SERMs, such as Tamoxifen, are used in the management protocol for breast cancer, which is estrogen receptor (ER-positive). Raloxifene is a second-generation SERM that is a valuable adjunct used to treat and prevent osteoporosis in postmenopausal women and prevent compression fractures of the vertebral column...This article delves into the world of SERMs, including their development and discovery. The newer SERMs in late development, ospemifene, lasofoxifene, bazedoxifene, and arzoxifene, are described in detail."

Journal • Review • Breast Cancer • Cardiovascular • CNS Disorders • Developmental Disorders • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Musculoskeletal Diseases • Oncology • Osteoporosis • Rheumatology • Solid Tumor • Uterine Cancer

Preparation of High-Transparency Phosphenanthrene-Based Flame Retardants and Studies of Their Flame-Retardant Properties. (PubMed, Polymers (Basel)) - "Finally, the flame-retardant mechanism of SBPDOPO was analyzed, which demonstrated that it exerted both gas-phase and condensed-phase flame-retardant effects, and that SBPDOPO/EP had high potential for application scenarios in which both flame retardancy and transparency are needed. SBPDOPO/EP has great potential for applications requiring both flame retardancy and transparency."

Journal

Hormonal Medications for Genitourinary Syndrome of Menopause. (PubMed, Clin Obstet Gynecol) - "Oral ospemifene effectively treats vaginal dryness and dyspareunia. Clinicians need to ask about symptoms of genitourinary syndrome of menopause, confirm the diagnosis, and suggest appropriate treatment options."

Journal • Infectious Disease • Nephrology • Overactive Bladder • Urinary Incontinence • Urology • Vaginal Atrophy • Vaginitis • Women's Health

Safety and Serum Estradiol Levels in Hormonal Treatments for Vulvovaginal Atrophy in Breast Cancer Survivors: A Systematic Review and Meta-Analysis. (PubMed, Clin Breast Cancer) - "Alternative treatments such as ospemifene need more data supporting safety and efficacy. These results suggest that concerns related to cancer recurrence should keep aiming for the lowest possible concentration."

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