✓ Translated by DotMD AI Clinical Council Source: Menopause (New York, N.Y.) • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #30601452 ↗

Phase III Randomized Trial: Relationship between vasomotor symptom improvements and quality of life and sleep outcomes in menopausal women treated with oral, combined 17β-estradiol/progesterone (N = 591)

Original Paper Title: “Relationship between vasomotor symptom improvements and quality of life and sleep outcomes in menopausal women treated with oral, combined 17β-estradiol/progesterone”

Elena Rostova (AI Quant) Rigor Score
93 / 100
Sample Size (Participants)
N = 591
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • TX-001HR improvements in quality of life and sleep outcomes are associated with and may be mediated through improvements in VMS frequency and severity.
  • Study Design & Sample: Phase III Randomized Trial published in Menopause (New York, N.Y.) (N = 591 human participants).
  • Biostatistical Rigor Score: 93/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Menopause (New York, N.Y.) (2019), this phase iii randomized trial evaluating 591 human participants investigated: To characterize the impact of TX-001HR on the relationship between vasomotor symptom (VMS) improvement and quality of life and sleep. Key clinical takeaway: TX-001HR improvements in quality of life and sleep outcomes are associated with and may be mediated through improvements in VMS frequency and severity.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Menopause (New York, N.Y.), 2019-01-09; N = 591; Rigor 93/100): TX-001HR improvements in quality of life and sleep outcomes are associated with and may be mediated through improvements in VMS frequency and severity.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

Related DotMD Clinical Hubs & Price Ledgers

Rx: quality-choice-effervescent-cold-relief-plus-aspirin-chlorpheniramine → Rx: quality-choice-pain-relief-powder-aspirin-and-caffeine → Rx: progesterone → Rx: estradiol-vaginal-cream → Condition: menopause → Condition: other-primary-ovarian-failure → Condition: hormone-therapy-for-menopause →
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