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Abstract
Several formulations combining estrogens and progestins for hormone therapy (HT) have
been approved worldwide for the treatment of menopausal symptoms, yet recent data
indicate a decline in their use and an increase in compounded bioidentical HT. Up
to now, no single product combining natural 17β-estradiol and progesterone has been
approved by the US Food and Drug Administration (FDA) or the European Medicines Agency
(EMA). A phase 3 trial (REPLENISH) is underway to study a novel oral formulation of
solubilized 17β-estradiol and natural progesterone combined in a single gelatin capsule
(TX-001HR; TherapeuticsMD, Inc, Boca Raton, FL) for treating vasomotor symptoms (VMS)
in postmenopausal women. The REPLENISH trial evaluates the efficacy and safety of
TX-001HR (4 doses) versus placebo for the reduction of moderate to severe VMS frequency
and severity at 4 and 12 weeks and evaluates the endometrial safety of the combinations
at 1 year. TX-001HR contains hormones that are molecularly identical to endogenous
estradiol and progesterone and is intended as an option for women who prefer bioidentical
hormones; further, it does not contain peanut oil, a common allergen. The constituents
of TX-001HR, in a pharmacokinetic report, showed similar bioavailability and safety
compared with reference estradiol tablets and micronized progesterone capsules administered
together. Published data suggest a safer profile of estradiol and natural progesterone
compared with HT containing conjugated equine estrogens and progestins. This report
summarizes the methodology of the REPLENISH trial and reviews the evidence suggesting
clinical differences between HT containing progesterone or progestins, and estradiol
or conjugated equine estrogens.