Breast effects of oral, combined 17β-estradiol, and progesterone capsules in menopausal women: a randomized controlled trial.

ABSTRACT:

Objective

To evaluate the effect of a single-capsule, bioidentical 17β-estradiol (E2) and progesterone (P4) hormone therapy on mammograms and breasts in postmenopausal women after 1 year of use.

Methods

In the 12-month, phase 3, randomized, double-blind, placebo-controlled, multicenter REPLENISH trial, postmenopausal women (40-65 y) with moderate to severe vasomotor symptoms and a uterus were randomized to four active daily dose groups of E2/P4 (TX-001HR) or a placebo group. Mammograms were performed and read locally at screening (or ≤6 months before first dose) and at study end using BI-RADS classification. Incidence of abnormal mammograms and breast adverse events was evaluated.

Results

All but 8 (0.4%) mammograms at screening were normal (BI-RADS 1 or 2). At 1 year

SUBMITTER: Liu JH 

PROVIDER: S-EPMC7709925 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature