Liu JH, Black DR, Larkin L, et al. - In this 12-month, phase 3, randomized, double-blind, placebo-controlled, multicenter REPLENISH trial, researchers sought to assess the impact 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. They randomized postmenopausal women (40-65 y) with moderate to severe vasomotor symptoms and a uterus to four active daily dose groups of E2/P4 (TX-001HR) or a placebo group. Data reported that breast cancer incidence was 0.36% with active doses and 0% with placebo. The findings of secondary outcomes in this phase 3 trial of a combined E2/P4 indicate that E2/P4 might not be linked to increased risk of abnormal mammograms vs placebo, and the incidence of breast tenderness was low compared with most of the rates recorded in other studies using hormone therapy.