Improvement in sleep outcomes with a 17β-estradiol-progesterone oral capsule (TX-001HR) for postmenopausal women.

ABSTRACT:

Objective

The aim of the study was to evaluate the effects of TX-001HR, a single-capsule 17β-estradiol-progesterone on sleep parameters in postmenopausal women with vasomotor symptoms (VMS) using the Medical Outcomes Study (MOS)-Sleep scale questionnaire in the REPLENISH trial.

Methods

In the REPLENISH trial (NCT01942668), women were randomized to one of four doses of TX-001HR or placebo, and the 12-item MOS-Sleep questionnaire (secondary endpoint) was self-administered at baseline, week 12, and months 6 and 12. Changes from baseline in the MOS-Sleep total score and 7 subscale scores were analyzed for treatment groups versus placebo at all time points. Somnolence was also collected as an adverse event.

Results

Women (mean age 55 y) were randomized to TX-001HR (estradi

SUBMITTER: Kagan R 

PROVIDER: S-EPMC6553506 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature