Trial reportMenopause (New York, N.Y.)2019
Relationship between vasomotor symptom improvements and quality of life and sleep outcomes in menopausal women treated with oral, combined 17β-estradiol/progesterone.
Trial report in Menopause (New York, N.Y.), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01942668 (A Phase 3 Study Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms in Postmenopausal Women With an Intact Uterus), which is not on this map. Cited by 11 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3 Study Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms in Postmenopausal Women With an Intact Uterus
Who cites it
11 citing papers in PubMed.
- Breast effects of oral, combined 17β-estradiol, and progesterone capsules in menopausal women: a randomized controlled trial.Menopause (New York, N.Y.) · 2020Trial
- Effects of combined 17β-estradiol and progesterone on weight and blood pressure in postmenopausal women of the REPLENISH trial.Menopause (New York, N.Y.) · 2020Trial
- Midlife Sleep and Circadian Health: Implications for Cardiovascular and Cognitive Outcomes.Obstetrics and gynecology clinics of North America · 2026Review
- Targeted literature review of concepts related to women's experiences and perceptions of vasomotor symptoms associated with menopause.Menopause (New York, N.Y.) · 2026Review
- The influence of menopausal status on sleep quality in different populations - a narrative review.Przeglad menopauzalny = Menopause review · 2025Review
- Review
- The effectiveness and value of fezolinetant for moderate-to-severe vasomotor symptoms associated with menopause: A summary from the Institute for Clinical and Economic Review's Midwest Public Advisory Council.Journal of managed care & specialty pharmacy · 2023Article
- A Clinical Review on Paroxetine and Emerging Therapies for the Treatment of Vasomotor Symptoms.International journal of women's health · 2022Review
- Contemporary Non-hormonal Therapies for the Management of Vasomotor Symptoms Associated with Menopause: A Literature Review.TouchREVIEWS in endocrinology · 2021Review
- Position Statement by Experts of the Polish Menopause and Andropause Society on menopausal hormone therapy with an oral combination drug containing oestradiol 1 mg and progesterone 100 mg.Przeglad menopauzalny = Menopause review · 2021Article
- Qualitative study: burden of menopause-associated vasomotor symptoms (VMS) and validation of PROMIS Sleep Disturbance and Sleep-Related Impairment measures for assessment of VMS impact on sleep.Journal of patient-reported outcomes · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo characterize the impact of TX-001HR on the relationship between vasomotor symptom (VMS) improvement and quality of life and sleep.
methodsREPLENISH (NCT01942668) was a phase 3, randomized, double-blind, placebo-controlled, multicenter trial, which evaluated four daily doses of 17β-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.
resultsOutcomes with all four E2/P4 doses were combined (n = 591) and compared with placebo (n = 135). 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, P < 0.001). 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.
conclusionsTX-001HR improvements in quality of life and sleep outcomes are associated with and may be mediated through improvements in VMS frequency and severity.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.