17β-Estradiol and natural progesterone for menopausal hormone therapy: REPLENISH phase 3 study design of a combination capsule and evidence review

Highlights • No combination natural estradiol/progesterone capsule is FDA or EMA approved. • REPLENISH studies a natural estradiol/progesterone capsule (TX-001HR). • Various doses of TX-001HR are being evaluated for treating hot flushes. • Safety outcomes differ among types of estrogens and among ty...

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Bibliographic Details
Published in:Maturitas 2015-05, Vol.81 (1), p.28-35
Main Authors: Mirkin, Sebastian, Amadio, Julia M, Bernick, Brian A, Pickar, James H, Archer, David F
Format: Article
Language:English
Subjects:
17β-Estradiol
Adult
Aged
Bioidentical hormones
Drug Combinations
Estradiol - adverse effects
Estradiol - therapeutic use
Estrogens - therapeutic use
Female
Hormone Replacement Therapy - methods
Hormones - therapeutic use
Humans
Internal Medicine
Menopause
Middle Aged
Obstetrics and Gynecology
Postmenopause
Progesterone
Progesterone - adverse effects
Progesterone - therapeutic use
Progestins - therapeutic use
Research Design
United States
Vasomotor symptoms
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Summary:Highlights • No combination natural estradiol/progesterone capsule is FDA or EMA approved. • REPLENISH studies a natural estradiol/progesterone capsule (TX-001HR). • Various doses of TX-001HR are being evaluated for treating hot flushes. • Safety outcomes differ among types of estrogens and among types of progestogens. • TX-001HR may be a safer hormone therapy option vs existing hormone therapies.
ISSN:0378-5122
1873-4111
DOI:10.1016/j.maturitas.2015.02.266