Mirkin S, Graham R, Revicki D, Bender R, Constantine GD. REPLENISH Trial: relationship between changes in frequency and severity of vasomotor symptoms and changes in quality of life and sleep outcomes in menopausal women treated with TX-001HR (Estrogen/Progesterone Oral Combination). Presented at the 2018 ENDO Meeting; March 18, 2018. Chicago, IL.

Menopausal vasomotor symptoms (VMS) are associated with impaired quality of life and increased sleep problems. TX-001HR (TherapeuticsMD, Boca Raton, FL), an investigational, 17β-estradiol and progesterone combined in a single, oral softgel capsule, for the treatment of moderate-to-severe VMS, was evaluated in the REPLENISH trial (NCT01942668), a phase 3, randomized, double-blind, placebo-controlled, multicenter trial. In menopausal women (40-65 years) with moderate-to-severe VMS (≥7/day or ≥50/week) and an intact uterus (n=726), TX-001HR was generally successful in reducing hot flush (HF) frequency and severity and in improving quality of life and sleep outcomes. The objective of this analysis was to characterize the relationship between treatment and changes in VMS and changes in Menopause-Specific Quality of Life (MENQOL) questionnaire and the Medical Outcomes Study (MOS)-Sleep scale scores. Growth models were used to examine the relationships between linear changes in HF frequency and severity over 12 weeks and changes from baseline in MENQOL (total score and VMS domain) and MOS-Sleep (total score, sleep problems index I and sleep problems index II) outcomes at 12 weeks. All four TX-001HR doses were combined (n=591) and compared with placebo (n=135). In all cases, the effects of TX-001HR on MENQOL total score and vasomotor domain were significantly related to changes in HF frequency and severity observed over 12 weeks (all, P<0.001). Similar results were found with MOS-Sleep total score and sleep problem indices. Treatment effects of TX-001HR compared with placebo on improvements in MENQOL and MOS-Sleep appear to be mediated through the improvements in HF frequency and severity. VMS improvements with TX-001HR may potentially lead to improvements in quality of life and sleep outcomes.

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