ospemifene
Sources réglementaires consultées
Indications approuvées
- Atrophie vulvo-vaginale symptomatique modérée ou sévère chez la femme ménopausée.
Contre-indications
Absolues
- Thromboembolie veineuse active ou antérieure, saignement vaginal inexpliqué, cancer du sein suspecté ou en cours de traitement, néoplasie hormonodépendante ou hyperplasie endométriale.
- Hypersensibilité à l’ospémifène ou aux excipients.
Mises en garde cliniques
- Mise en garde majeure · Explorer tout saignement vaginal. Arrêter 4 à 6 semaines avant et pendant une immobilisation prolongée ; évaluer les risques de thromboembolie veineuse, d’accident vasculaire cérébral et d’effets endométriaux. — CIMA/AEMPS, ficha técnica 114978002
- Mise en garde majeure · Non recommandé en cas d’insuffisance hépatique sévère. — CIMA/AEMPS, ficha técnica 114978002
Interactions médicamenteuses
- ModéréeFluconazole
Mécanisme: Il augmente l’exposition à l’ospémifène d’environ 2,7 fois.
Recommandation: Utiliser avec prudence et interrompre l’ospémifène pendant le traitement si la tolérance diminue.
CIMA/AEMPS, ficha técnica 114978002https://cima.aemps.es/cima/dochtml/ft/114978002/FT_114978002.html
- ModéréeInducteurs puissants du CYP3A4/CYP2C9
Mécanisme: Ils réduisent l’exposition et peuvent diminuer l’effet clinique.
Recommandation: Éviter l’association ou réévaluer l’efficacité.
CIMA/AEMPS, ficha técnica 114978002https://cima.aemps.es/cima/dochtml/ft/114978002/FT_114978002.html
- SévèreŒstrogènes ou autres modulateurs sélectifs des récepteurs aux œstrogènes, notamment tamoxifène, torémifène, raloxifène et bazédoxifène
Mécanisme: La sécurité de l’utilisation concomitante n’a pas été étudiée.
Recommandation: L’utilisation concomitante n’est pas recommandée.
CIMA/AEMPS, ficha técnica 114978002https://cima.aemps.es/cima/dochtml/ft/114978002/FT_114978002.html
Effets indésirables
Communs (≥1%)
Bouffées de chaleur · Candidose vulvo-vaginale · Céphalées · Spasmes musculaires · Écoulement ou saignement vaginal
Rares mais graves
Thrombose veineuse profonde ou embolie pulmonaire · Accident vasculaire cérébral · Hypersensibilité avec œdème pharyngé
Grossesse et allaitement
Indiqué uniquement chez la femme ménopausée. Arrêter immédiatement en cas de grossesse ; il n’est pas indiqué pendant l’allaitement.
Bibliographie récente (PubMed)
"The 2022 Hormone Therapy Position Statement of The North American Menopause Society" (NAMS) updates "The 2017 Hormone Therapy Position Statement of The North American Menopause Society" and identifies future research needs. An Advisory Panel of clinicians and researchers expert in the field of women's health and menopause was recruited by NAMS to review the 2017 Position Statement, evaluate new literature, assess the evidence, and reach consensus on recommendations, using the level of evidence to identify the strength of recommendations and the quality of the evidence. The Advisory Panel's recommendations were reviewed and approved by the NAMS Board of Trustees.Hormone therapy remains the most effective treatment for vasomotor symptoms (VMS) and the genitourinary syndrome of menopause and has been shown to prevent bone loss and fracture. The risks of hormone therapy differ depending on type, dose, duration of use, route of administration, timing of initiation, and whether a progestogen is used. Treatment should be individualized using the best available evidence to maximize benefits and minimize risks, with periodic reevaluation of the benefits and risks of continuing therapy.For women aged younger than 60 years or who are within 10 years of menopause onset and have no contraindications, the benefit-risk ratio is favorable for treatment of bothersome VMS and prevention of bone loss. For women who initiate hormone therapy more than 10 years from menopause onset or who are aged older than 60 years, the benefit-risk ratio appears less favorable because of the greater absolute risks of coronary heart disease, stroke, venous thromboembolism, and dementia. Longer durations of therapy should be for documented indications such as persistent VMS, with shared decision-making and periodic reevaluation. For bothersome genitourinary syndrome of menopause symptoms not relieved with over-the-counter therapies in women without indications for use of systemic hormone therapy, low-d
Menopause, due to loss of ovarian follicular activity without another pathological or physiological cause, typically occurs between the ages of 45 years and 56 years. During the menopausal transition, approximately 50% to 75% of women have hot flashes, night sweats, or both (vasomotor symptoms) and more than 50% have genitourinary symptoms (genitourinary syndrome of menopause [GSM]). Vasomotor symptoms typically last more than 7 years and GSM is often chronic. Efficacious treatments for women with bothersome vasomotor symptoms or GSM symptoms include hormonal and nonhormonal options. Systemic estrogen alone or combined with a progestogen reduces the frequency of vasomotor symptoms by approximately 75%. Oral and transdermal estrogen have similar efficacy. Conjugated equine estrogens (CEE) with or without medroxyprogesterone acetate (MPA) were the only hormonal treatments for which clinical trials were designed to examine cardiovascular events, venous thromboembolism, and breast cancer risk. Compared with placebo, the increased risk of stroke and venous thromboembolism associated with CEE (with or without MPA) and breast cancer (with use of CEE plus MPA) is approximately 1 excess event/1000 person-years. Low-dose CEE plus bazedoxifene is not associated with increased risk of breast cancer (0.25%/year vs 0.23%/year with placebo). Bioidentical estrogens approved by the US Food and Drug Administration (with identical chemical structure to naturally produced estrogens, and often administered transdermally) also are available to treat vasomotor symptoms. For women who are not candidates for hormonal treatments, nonhormonal approaches such as citalopram, desvenlafaxine, escitalopram, gabapentin, paroxetine, and venlafaxine are available and are associated with a reduction in frequency of vasomotor symptoms by approximately 40% to 65%. Low-dose vaginal estrogen is associated with subjective improvement in GSM symptom severity by approximately 60% to 80%, with improvement in
Postmenopausal women commonly experience vulvovaginal, urinary, and sexual symptoms associated with genitourinary syndrome of menopause (GSM). To evaluate effectiveness and harms of vaginal estrogen, nonestrogen hormone therapies, and vaginal moisturizers for treatment of GSM symptoms. Medline, Embase, and CINAHL through 11 December 2023. Randomized controlled trials (RCTs) of at least 8 weeks' duration enrolling postmenopausal women with at least 1 GSM symptom and reporting effectiveness or harms of hormonal interventions or vaginal moisturizers. Risk of bias and data extraction were performed by one reviewer and verified by a second reviewer. Certainty of evidence (COE) was assessed by one reviewer and verified by consensus. From 11 993 citations, 46 RCTs evaluating vaginal estrogen (k = 22), nonestrogen hormones (k = 16), vaginal moisturizers (k = 4), or multiple interventions (k = 4) were identified. Variation in populations, interventions, comparators, and outcomes precluded meta-analysis. Compared with placebo or no treatment, vaginal estrogen may improve vulvovaginal dryness, dyspareunia, most bothersome symptom, and treatment satisfaction. 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). Although studies did not report frequent serious harms, reporting was limited by short-duration studies that were insufficiently powered to evaluate infrequent serious harms. Most studies were 12 weeks or less in duration and used heterogeneous GSM diagnostic criteria and outcome measures. Few studies enrolled women with a history of cancer. Vaginal estrogen, vaginal
The 19th World Congress on Menopause, hosted by the International Menopause Society in 2024, convened global experts to discuss the latest advances in menopause management. This review highlights key focus areas presented at the congress, offering insights into best practices for clinical application. Cardiovascular health remains a priority, with emphasis on recognizing sex-specific risk factors and exploring emerging therapies. Osteoporosis management underscores the role of menopausal hormone therapy (MHT) as foundational, complemented by anti-resorptive and bone-forming agents in high-risk populations and those not candidates for MHT. 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. Sleep disturbances, depression and workplace challenges linked to menopause were explored, with tailored interventions such as MHT and cognitive behavioral therapy specifically for sleep recommended. 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.
Evaluation and treatment of dyspareunia remains a significant unmet need despite the availability of safe and effective treatments. The objectives of this review are to consider evaluation techniques, the medical causes, and treatment options for dyspareunia in postmenopausal women. This narrative review used PubMed to search for English-language articles related to postmenopausal dyspareunia. Search terms included, but were not limited to, dyspareunia, genitourinary syndrome of menopause, sexual dysfunction, postmenopausal dyspareunia, posthysterectomy dyspareunia, and postcancer dyspareunia. Many postmenopausal women with dyspareunia do not discuss their symptoms with their physicians. Healthcare clinicians should broach the topic of dyspareunia with their patients using oral or written questionnaires. In addition to a thorough medical history and physical examination, various tools can be used as further assessments, including vaginal pH, vaginal dilators, imaging, vulvar biopsy, vulvoscopy and photography, the cotton swab test, sexually transmitted infection screening, and vaginitis testing. Although dyspareunia in postmenopausal women is often due to the genitourinary syndrome of menopause, other conditions can also cause dyspareunia, including hypertonic pelvic floor, hysterectomy, cancer treatment, lichen conditions, vulvar cancer, vestibulodynia, and pelvic organ prolapse. Some of the treatments discussed include lubricants, moisturizers, vaginal estrogen, ospemifene, dehydroepiandrosterone, local testosterone therapy, cannabidiol, and fractional CO 2 laser treatments. In some cases, dyspareunia may need to be specifically addressed by pelvic floor physical or sex therapists. Dyspareunia is a common issue in postmenopausal women, which remains largely untreated. Women with dyspareunia require a thorough history, targeted physical examination, and coordination of multiple disciplines including medical clinicians, pelvic floor physical therapists, and sex ther