Qualia Perimenopause Efficacy and Tolerability Study: An Open-label 3-Arm Trial (NCT07361757) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Qualia Perimenopause Efficacy and Tolerability Study: An Open-label 3-Arm Trial
120 participantsStarted 2026-02-01
Plain-language summary
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.
Who can participate
Age range40 Years – 55 Years
SexFEMALE
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Inclusion criteria
✓. Provide voluntary, written, informed consent to participate in the study
✓. Agree to provide a valid cell phone number and are willing to receive communications through text
✓. Can read and write English
✓. Willing to not begin taking any new supplements during the study and continue taking any supplements they are currently using regularly
✓. Willing to complete questionnaires, records, and diaries associated with the study
✓. Healthy female participants ages 40-55 with menopause symptoms but not yet in menopause (period within last 12 months)
✓. MRS total score ≥ 5 (preference given to higher score)
Exclusion criteria
✕. Women who are pregnant, breastfeeding, or planning to become pregnant or start breastfeeding during the trial
✕. Known food intolerances/allergy to any ingredients in the product