An interventional study of Qualia Perimenopause Formula A and Qualia Perimenopause Formula B in Peri-menopausal Women, sponsored by Qualia Life Sciences. Completed at 1 site in United States. Open to female participants aged 40 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Qualia Life Sciences · Not applicable, Interventional, and Other
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.
Perimenopause is a transitional phase preceding menopause characterized by fluctuating ovarian hormone levels and variable cycle length, often accompanied by a constellation of symptoms spanning vasomotor disturbances, sleep disruption, cognitive and attentional changes, mood lability, somatic complaints, and urogenital discomfort. These symptoms can meaningfully impair quality of life, productivity, interpersonal functioning, and health-related well-being. Although menopausal hormone therapy is an established option for selected individuals, many women either do not elect or are not candidates for hormone-based interventions and seek nonhormonal approaches that address multiple symptom domains concurrently. In this context, multi-ingredient botanical formulations are of growing interest as supportive strategies designed to target the diverse and interrelated pathways implicated in perimenopausal symptomatology.
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.
Study Design: This is an open-label, three-arm, parallel-group trial with stratified systematic allocation by baseline Menopause Rating Scale (MRS) total score. Participants will be stratified and assigned to one of three study arms in a 1:1:1 ratio. Study duration is 28 days of supplementation.
Participants will take one capsule once daily of their assigned formula for 28 consecutive days. All data are self-reported; assessments are completed electronically at home at baseline, mid-intervention (day 14), and end-of-study (day 28), with a brief follow-up questionnaire. Approximately 120 healthy female participants ages 40-55 with menopause symptoms but not yet in menopause (period within last 12 months) and MRS total score ≥ 5 will be enrolled.
Note on allocation (added September 2026): Participants were assigned to study arms by systematic allocation rather than by random allocation. Earlier versions of this record described the design as randomized. The Allocation field and the design descriptions were corrected to Non-Randomized to reflect the method actually used. No other aspect of the study design, conduct, or analysis changed.
Qualia Life Sciences is the lead sponsor of 14 studies on the registry; 5 are open to participants now.
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Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary Supplement: Qualia Perimenopause Formula A
Dietary Supplement: Qualia Perimenopause Formula B
Dietary Supplement: Qualia Perimenopause Formula C
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 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 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).
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.
Time frame: Day 28
PROMIS Cognitive Function v2.0 - Short Form 8a
Within- and between-group changes from baseline to Days 14 and 28 in cognitive function measured by PROMIS Cognitive Function v2.0 - Short Form 8a, an 8-item assessment of perceived cognitive abilities including mental acuity, concentration, and memory.
Time frame: Day 14, Day 28
Safety and Tolerability Survey
Within- and between-group changes from baseline to Days 14 and 28 in side effect profile using a custom Safety and Tolerability survey assessing symptoms including nausea, headache, mood changes, dizziness, bloating, itching, and sexual dysfunction.
Time frame: Day 14, Day 28
PROMIS Sleep Disturbance - Short Form
Within- and between-group changes from baseline to Days 14 and 28 in sleep measured by PROMIS Sleep Disturbance - Short Form, an 8-item assessment of sleep quality, restfulness, and disturbance severity.
Time frame: Day 14, Day 28
MRS Psychological Subdomain
Within- and between-group changes from baseline to Days 14 and 28 in the Psychological subdomain of the Menopause Rating Scale (items 4-7: depressive mood, irritability, anxiety, exhaustion).
Time frame: Day 14, Day 28
MRS Somato-Vegetative Subdomain
Within- and between-group changes from baseline to Days 14 and 28 in the Somato-vegetative subdomain of the Menopause Rating Scale (items 1-3, 11: hot flashes, heart discomfort, sleep problems, joint/muscle discomfort).
Time frame: Day 14, Day 28
MRS Urogenital Subdomain
Within- and between-group changes from baseline to Days 14 and 28 in the Urogenital subdomain of the Menopause Rating Scale (items 8-10: sexual problems, bladder problems, vaginal dryness).
Time frame: Day 14, Day 28
Follow-up Questionnaire
Participant thoughts and feelings about the product assessed via a Follow-up Questionnaire administered 5-7 days after the final dose. Evaluates overall experience, product rating, purchase interest, and detailed product experience description.
Time frame: Day 33 (5-7 days after final dose)
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2026 to primary completion in Apr 2026, 1 month.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 5, 2026: start Feb 2026 → Mar 2026 and primary completion Mar 2026 → Apr 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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