Livial (tibolone) / Organon - LARVOL DELTA

Treatment patterns of menopausal hormone therapy in South Korea: a nationwide cohort study. (PubMed, Climacteric) - "MHT was classified into three classes including estrogen therapy (ET), estrogen plus progestogen therapy (EPT) and tibolone, with routes of administration categorized as systemic (oral, transdermal) and local (transvaginal)...Systemic MHT was discontinued after an average of 13.2 months, while local MHT was discontinued after 2.4 months. Despite guidelines recommending MHT for treating menopausal symptoms, many women remain untreated and continued MHT for an average of only 1 year."

Journal

Menopausal Hormone Therapy and the Risk of Stroke: A Nationwide Cohort Study. (PubMed, Yonsei Med J) - "Women currently receiving MHT without underlying cardiovascular disease exhibited an increased risk of ischemic stroke, particularly those treated with E-only MHT or tibolone. However, this increased risk returned to baseline after discontinuing MHT, indicating that past use of MHT was not associated with an increased risk of ischemic stroke."

Journal • Retrospective data • Cardiovascular • Coronary Artery Disease • Heart Failure • Ischemic stroke

Acute administration of tibolone reduces oxidative stress and inflammation in a rat model of traumatic spinal cord injury. (PubMed, Neurol Res) - "TIB demonstrated a protective effect by decreasing OS and inflammation after SCI, suggesting an estrogenic effect of this STEAR. However, further studies should be conducted to elucidate the exact mechanism by which TIB exerts neuroprotection after SCI."

Journal • Preclinical • CNS Disorders • Inflammation • Orthopedics • IL1B • IL6 • TNFA

Gonadotropin-releasing hormone (GnRH) analogues for premenstrual syndrome (PMS). (PubMed, Cochrane Database Syst Rev) - "This review found that GnRH agonists without add-back improved global symptoms of premenstrual syndrome. However, the induced menopausal side effects and potential complications preclude long-term use. We found insufficient evidence to suggest that side effects can be reduced by 'add-back' without decreasing the global efficacy of GnRH agonists. Further RCTs of GnRH agonists with add-back and long-term follow-up are therefore needed to provide firm conclusions about long-term use. Until data are available to confirm or refute the safety of this combination, GnRH agonists with or without add-back can be administered to provide a short-term break from PMS symptoms. Future studies should attempt to assess the risk of osteoporosis."

Clinical • Journal • Review • CNS Disorders • Depression • Gynecology • Mental Retardation • Osteoporosis • Psychiatry • Rheumatology

Analysis of Menopausal Hormone Therapy to Chinese Patients with Menopausal Syndrome: A Real-World Retrospective Study from Chinese Hospitals. (PubMed, Drug Des Devel Ther) - "The estradiol/estradiol dydrogesterone and tibolone were the main sex hormone drugs that were used to treat MPS. The state's abolition of the drug price addition policy and the organization of centralized drug procurement in some areas had alleviated the financial burdens on patients to a certain extent."

Journal • Real-world evidence • Retrospective data

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

Cardiovascular outcomes of menopause hormone therapy initiated in women aged ≥60 years or ≥10 years post-menopause: A systematic review of the literature. (PubMed, Post Reprod Health) - "Non-WHI studies showed an elevated stroke risk with tibolone and higher doses of combined MHT, but no cardiovascular complications were observed with low doses.ConclusionThe increased risk of cardiovascular events in our target population is not statistically significant. There is a lack of high-quality evidence to suggest an increased risk of adverse cardiovascular outcomes in healthy women who initiate MHT at age ≥60 years or ≥10 years post-menopause."

Journal • Review • Cardiovascular • Women's Health

Combining hormone replacement therapy and adjuvant treatment for a patient with resistant prolactinoma: a new clinical strategy (ESPE-ESE 2025) - "We administered cabergoline starting at 0.5 mg per week...In 2023–2024, with bromocriptine (5 mg/day) and tamoxifen (20 mg/day), PRL remained within the normal range... Tibolone, unlike traditional HRT, selectively activates estrogen receptors, minimizing prolactin secretion and tumor risk. This makes it a safer option for menopausal women with well-controlled prolactinomas. Conclusions : HRT helps manage vasomotor symptoms and prevent osteoporosis, but estrogen can stimulate tumor growth."

Clinical • Endocrine Cancer • Fatigue • Gynecology • Oncology • Osteoporosis • Pain • Pituitary Gland Carcinoma • Rheumatology • ER • PRL

Cardiovascular disease and female sexual health across the life span: a bidirectional link. (PubMed, Maturitas) - "Hormonal treatment for sexual dysfunction in women with cardiovascular risk factors is discussed, concerning menopausal hormone therapy, tibolone, selective estrogen receptor modulators, vaginal estrogen, prasterone and testosterone therapy...However, effectively addressing the challenges of aging and further highlighting the positive impact of sexual activity on cardiac health in selected female populations could significantly enhance life motivation and promote a healthy lifestyle during this stage. The present review elucidates the bidirectional relationship between CVD and female sexual function."

Journal • Review • Cardiovascular • Coronary Artery Disease • Dyslipidemia • Heart Failure • Hypertension • Metabolic Disorders • Myocardial Infarction • Pain • Sexual Disorders

The Effect of Tibolone on Body Weight, Body Fat, and Metabolic Components (ECO 2025) - No abstract available

Late-breaking abstract

Differential cardiovascular risks of menopausal hormone therapy: insights from a Korean cohort. (PubMed, Eur J Endocrinol) - No abstract available

Journal • Cardiovascular

Association between duration, initiation time, routes, and formulations of menopausal hormone therapy use and Alzheimer disease in women: A systematic review and meta-analysis. (PubMed, J Pharmacol Exp Ther) - "Tibolone increased AD risk (cohort, RR = 1.04, 95% CI: 1.01-1.07; case-control, OR = 1.07, 95% CI: 1.01-1.14)...MHT lowered AD risk in apolipoprotein E genotype 4 allele carriers, individuals with depression, and Americans. MHT regimens should be highly personalized."

Journal • Retrospective data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Depression • Psychiatry • APOE

Study on the efficacy of different MHT protocols in intervening with cognitive function in perimenopausal and postmenopausal women with sleep disorder based on fNIRS detection (ChiCTR) - P=N/A | N=90 | Not yet recruiting | Sponsor: Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; Shanghai Sixth People's Hospital Affiliated to Shangh

New trial • CNS Disorders • Sleep Disorder

Relation between pelvic organ prolapse and menopausal hormone therapy: nationwide cohort study. (PubMed, Obstet Gynecol Sci) - "After menopause, tibolone and CEPM were associated with a reduced POP risk compared with non-MHT. Other oral MHT and transdermal estrogen were not associated with the risk of POP."

Journal

Update of the impact of menopausal hormone therapy on breast cancer risk. (PubMed, Eur J Cancer) - "Despite possible changes towards safer MHT prescribing, our data collected largely in early millennium show at least as large BC risk elevations in MHT users as seen in older studies."

Journal • Breast Cancer • Oncology • Solid Tumor

Response by Yuk et al to Letter Regarding Article, "Association of menopausal hormone therapy with risk of cardiovascular disease in Korean women". (PubMed, Eur J Endocrinol) - No abstract available

Journal • Cardiovascular

The effects of menopausal hormone therapy for the risk of systemic lupus erythematosus: A nationwide cohort study in Korea. (PubMed, Semin Arthritis Rheum) - "The utilization of MHT did not demonstrate a substantial impact on the development of SLE in postmenopausal women. Caution is required in the early stages of tibolone use."

Journal • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Association of menopausal hormone therapy with risk of cardiovascular disease in Korean women. (PubMed, Eur J Endocrinol) - "There was an increased risk of CVD in MHT users. By regimen, tibolone use was associated with increased risk of CVD, whereas estrogen either alone or in combination with progestogen was not. There was no difference according to the type of estrogen. The type of progestogen seems to modify the results, since dydrogesterone was associated with reduced CVD risk."

Journal • Cardiovascular

PHARMACOLOGICAL OPTIONS FOR MANAGING BURNING MOUTH SYNDROME. (WRMC 2025) - "Other medications evaluated included: amisulpride, aripiprazole, bupivacaine, cannabis, duloxetine, gabapentin, lysozyme-lactoperoxidase, melatonin, milnacipran, naltrexone, olanzapine, palmitoylethanlamide, paroxetine, pramipexole, pregabalin, sertraline, tibolone, and vortioxetine...Conclusions Although few studies have evaluated the use of pharmacological agents in the management of BMS, several have demonstrated efficacy including ALA, clonazepam, and capsaicin. Providers may refer to this review when managing patients with BMS. Drug Mechanism of Actions and Adverse Effects"

Dyspepsia • Pain

Contemporary menopausal hormone therapy and risk of cardiovascular disease: Swedish nationwide register based emulated target trial. (PubMed, BMJ) - "Use of oral oestrogen-progestin therapy was associated with an increased risk of heart disease and venous thromboembolism, whereas the use of tibolone was associated with an increased risk of ischaemic heart disease, cerebral infarction, and myocardial infarction but not venous thromboembolism. These findings highlight the diverse effects of different hormone combinations and administration methods on the risk of cardiovascular disease."

Journal • Cardiovascular • CNS Disorders • Coronary Artery Disease • Heart Failure • Myocardial Infarction • Venous Thromboembolism

Utilization and Expenditure on Medicines for the Prevention and Treatment of Osteoporosis: A Changing Landscape (ISPOR-EU 2024) - "Data was included on claims from 1st January 2011 to 31 December 2023 for dispensed medicines that are licensed for the management of osteoporosis; bisphosphonates (alendronate, ibandronate, risedronate), teriparatide, denosumab, selective oestrogen receptor modulators (SERMS) (raloxifene, bazedoxifene) and tibolone. This study highlights the changing landscape of osteoporosis prevention and treatment in Ireland, over a 13-year period. Further research into treatment adherence with these therapies is warranted, given an aging population and attendant increase in fractures with associated healthcare resource use."

Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

Tibolone treatment after traumatic brain injury exerts a sex-specific and Y chromosome-dependent regulation of methylation and demethylation enzymes and estrogen receptors in the cerebral cortex. (PubMed, Biochim Biophys Acta Mol Basis Dis) - No abstract available

Journal • CNS Disorders • Vascular Neurology • ER

Menopause and endometriosis. (PubMed, Maturitas) - "Current recommendations lean towards prioritizing combined menopausal hormone therapy formulations or tibolone over estrogen-only therapies due to their potentially higher malignancy risk. The possible increased risk of osteoporosis and cardiovascular disease in postmenopausal women with endometriosis is likely linked to a history of surgical menopause at an earlier age, but more research is warranted. This narrative review summarizes the available literature and provides insights into the intricate connection between endometriosis and menopause, shedding light on pathogenesis, symptoms, oncologic risk, diagnosis, and treatment."

Journal • Review • Cardiovascular • Endometriosis • Gynecology • Oncology • Osteoporosis • Pain • Rheumatology • Women's Health

Effect of Chronic Tibolone Administration on Memory and Choline Acetyltransferase and Tryptophan Hydroxylase Content in Aging Mice. (PubMed, Brain Sci) - "In the case of TPH, no changes were observed with either TIB dose. These results show that long-term TIB administration improves memory without affecting locomotor activity and modulates cholinergic but not serotonergic systems in the hippocampus of aged male mice."

Journal • Preclinical • Breast Cancer • CNS Disorders • Oncology • Solid Tumor • CHAT

Menopausal Hormone Therapy and Osteoarthritis Risk: Retrospective Population-Based Study in South Korea. (PubMed, J Menopausal Med) - "MHT was associated with an increased risk of osteoarthritis, consistently observed across tibolone, EPT, and ET, particularly affecting joints other than the hip, with a trend toward an elevated risk of hip osteoarthritis."

Journal • Retrospective data • Immunology • Osteoarthritis • Pain • Rheumatology