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Abstract
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.
Declaration of interest
BS Komm is an employee of Pfizer. JH Pickar was formerly an employee of Wyeth Research, and has received consultant fees from Wyeth/Pfizer, Besins Healthcare, Shionogi, Inc., Metagenics, and TherapeuticsMD. Medical writing support was provided by L Cerruto at Peloton Advantage, LLC, and was funded by Pfizer. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.