Introduction: The majority of women experience bothersome symptoms postmenopause (e.g., hot flushes, vaginal symptoms). Estrogen receptor agonists remain the most effective options for ameliorating menopausal symptoms. However, use of hormonal therapies has declined in the wake of issues raised by the Women's Health Initiative trials. As a result, there is a need for new safe and effective alternatives to estrogen-progestogen hormone therapy.
Areas covered: We review the efficacy and safety profile of hormonal menopausal therapies that are in Phase III clinical trials or recently approved. Investigational treatments discussed include two new vaginal estrogen products (TX-004HR, WC-3011); the first combination of estradiol and progesterone, and a novel combination of dehydroepiandrosterone and acolbifene. We also review a new selective estrogen receptor modulator (SERM), ospemifene, recently approved for treatment of dyspareunia related to menopause, and conjugated estrogens plus bazedoxifene, an estrogens/SERM combination, recently approved for moderate-to-severe vasomotor symptoms and prevention of osteoporosis.
Expert opinion: New and emerging hormonal treatments for managing menopausal symptoms may have improved safety and efficacy profiles compared with traditional estrogen-progestogen therapy; however, long-term safety data will be needed.
Keywords: TX-001HR; TX-004HR; WC-3011; conjugated estrogens/bazedoxifene; dehydroepiandrosterone/acolbifene; estrogen receptors; hormone therapy; menopause; ospemifene.