NCT07361757

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

January 15, 2026

Last Update Submit

January 15, 2026

Conditions

Peri-menopausal Women

Outcome Measures

Primary Outcomes (1)

  • Menopause Rating Scale (MRS) - Total Score

    Between-group change from baseline to Day 28 in menopause symptoms measured by the total Menopause Rating Scale (MRS) score. The MRS is an 11-item self-rating scale that measures the severity of menopausal symptoms with a total score range of 0-44.

    Day 28

Secondary Outcomes (7)

  • PROMIS Cognitive Function v2.0 - Short Form 8a

    Day 14, Day 28

  • Safety and Tolerability Survey

    Day 14, Day 28

  • PROMIS Sleep Disturbance - Short Form

    Day 14, Day 28

  • MRS Psychological Subdomain

    Day 14, Day 28

  • MRS Somato-Vegetative Subdomain

    Day 14, Day 28

  • +2 more secondary outcomes

Study Arms (3)

Qualia Perimenopause Formula A

EXPERIMENTAL
Dietary Supplement: Qualia Perimenopause Formula A

Qualia Perimenopause Formula B

EXPERIMENTAL
Dietary Supplement: Qualia Perimenopause Formula B

Qualia Perimenopause Formula C

EXPERIMENTAL
Dietary Supplement: Qualia Perimenopause Formula C

Interventions

Qualia Perimenopause Formula ADIETARY_SUPPLEMENT

Qualia Perimenopause is a multi-botanical natural health product/dietary supplement formulated to support women during the perimenopausal transition. The formulation is intended to address common domains of symptom burden-including vasomotor, psychological, cognitive, and sleep-related complaints-through complementary mechanisms of action. Participants receive one capsule once daily for 28 consecutive days. Three different formulations are being tested in this trial (Formula A, Formula B, and Formula C).

Qualia Perimenopause Formula A
Qualia Perimenopause Formula BDIETARY_SUPPLEMENT

Qualia Perimenopause is a multi-botanical natural health product/dietary supplement formulated to support women during the perimenopausal transition. The formulation is intended to address common domains of symptom burden-including vasomotor, psychological, cognitive, and sleep-related complaints-through complementary mechanisms of action. Participants receive one capsule once daily for 28 consecutive days. Three different formulations are being tested in this trial (Formula A, Formula B, and Formula C).

Qualia Perimenopause Formula B
Qualia Perimenopause Formula CDIETARY_SUPPLEMENT

Qualia Perimenopause is a multi-botanical natural health product/dietary supplement formulated to support women during the perimenopausal transition. The formulation is intended to address common domains of symptom burden-including vasomotor, psychological, cognitive, and sleep-related complaints-through complementary mechanisms of action. Participants receive one capsule once daily for 28 consecutive days. Three different formulations are being tested in this trial (Formula A, Formula B, and Formula C).

Qualia Perimenopause Formula C

Eligibility Criteria

Age40 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • Taking MAO inhibitors, SSRIs, or any other psychiatric or neurological medicines
  • On immunosuppressive therapy
  • Having had surgery within the past 6 weeks or upcoming planned surgery in the next few months
  • Adults lacking capacity to consent
  • Post-menopause (≥12 consecutive months without a period)
  • Taking medications: hormone replacement therapy; oral contraceptives; selective estrogen receptor modulators/aromatase inhibitors (e.g., Tamoxifen); sedatives/anxiolytics; blood thinners; insulin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

William Scuba

CONTACT

855-281-2328support@qualialife.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2026

First Posted

January 23, 2026

Study Start

February 1, 2026

Primary Completion

March 31, 2026

Study Completion

April 30, 2026

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share