Relationship between vasomotor symptom improvements and quality of life and sleep outcomes in menopausal women treated with oral, combined 17ß-estradiol/progesterone.
Menopause
; 26(6): 637-642, 2019 01 09.
Article
in En
| MEDLINE
| ID: mdl-30601452
ABSTRACT
OBJECTIVE:
To characterize the impact of TX-001HR on the relationship between vasomotor symptom (VMS) improvement and quality of life and sleep.METHODS:
REPLENISH (NCT01942668) was a phase 3, randomized, double-blind, placebo-controlled, multicenter trial, which evaluated four daily doses of 17ß-estradiol and progesterone (E2/P4) combined in a single, oral, softgel capsule in postmenopausal women (40-65 years) with a uterus and moderate to severe VMS (≥7/day or ≥50/week). In post hoc analyses, growth models were used to examine relationships between linear changes in VMS frequency and severity over 12 weeks and changes from baseline in the Menopause-Specific Quality of Life (MENQOL; total score and VMS domain) and the Medical Outcomes Study-Sleep (total score, sleep problems indices I and II) questionnaire outcomes at 12 weeks with treatment compared with placebo.RESULTS:
Outcomes with all four E2/P4 doses were combined (nâ=â591) and compared with placebo (nâ=â135). In all 5 growth models, the effects of TX-001HR on MENQOL total score and vasomotor domain were significantly associated with changes in VMS frequency and severity observed over 12 weeks (all, Pâ<â0.001). Treatment-mediated effects on MENQOL via VMS frequency and severity models were significant. Similar results were found with Medical Outcomes Study-Sleep total score and sleep problems indices.CONCLUSIONS:
TX-001HR improvements in quality of life and sleep outcomes are associated with and may be mediated through improvements in VMS frequency and severity.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Progesterone
/
Quality of Life
/
Sleep
/
Estrogen Replacement Therapy
/
Postmenopause
/
Hot Flashes
/
Estradiol
Type of study:
Clinical_trials
/
Diagnostic_studies
/
Prognostic_studies
Limits:
Adult
/
Aged
/
Female
/
Humans
/
Middle aged
Language:
En
Journal:
Menopause
Journal subject:
GINECOLOGIA
Year:
2019
Type:
Article