Qualia Perimenopause Efficacy and Tolerability Study: An Open-label 3-Arm Trial

This is an open-label, 3-arm clinical trial evaluating the short-term efficacy and tolerability of Qualia Perimenopause-a multi-ingredient dietary supplement formulated to support perimenopausal symptoms-in healthy women aged 40-55 who are symptomatic but not yet menopausal (menses within the past 12 months). Approximately 120 participants will be allocated across three parallel arms and will take 1 capsule once daily for 28 consecutive days. The primary outcome is between-group change from baseline to day 28 in menopause symptom burden measured by the total Menopause Rating Scale (MRS). Secondary outcomes include within- and between-group changes at days 14 and 28 in cognitive function (PROMIS Cognitive Function v2.0 - Short Form 8a), sleep disturbance (PROMIS), MRS subdomains (psychological, somato-vegetative, urogenital), overall MRS change, safety/tolerability (custom survey), and participant-reported product experience. All assessments are completed electronically at home at baseline, mid-intervention (day 14), and end-of-study (day 28), with a brief follow-up questionnaire; there are no in-person visits.

NCT Number	NCT07361757
Lead Sponsor	Qualia Life Sciences
Conditions	Peri-menopausal Women
Enrollment	120 participants
Start Date	2026-02-01
Primary Completion	2026-03-31 (estimated)
Study Completion	2026-04-30 (estimated)
Updated on ClinicalTrials.gov	2026-01-23