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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-55
SponsorQualia Life Sciences

About this 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, cancer

Having had a significant cardiovascular event in the past 6 months

Trial design

Treatments tested in this trial

  • Qualia Perimenopause Formula A
  • Qualia Perimenopause Formula B
  • Qualia Perimenopause Formula C

Treatment groups

120 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators