Peri-menopausal WomenNCT07361757
Qualia Perimenopause Efficacy and Tolerability Study: An Open-label 3-Arm Trial
A study testing Qualia Perimenopause Formula A, Qualia Perimenopause Formula B and Qualia Perimenopause Formula C in people with Peri-menopausal Women, run by Qualia Life Sciences at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 55 years, women only
- Conditions the study is for
- Peri-menopausal Women
- What is being tested?
- Qualia Perimenopause Formula A, Qualia Perimenopause Formula B and Qualia Perimenopause Formula C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2026to 27 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Peri-menopausal Women
- Being tested
- Qualia Perimenopause Formula A, Qualia Perimenopause Formula B, Qualia Perimenopause Formula C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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 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).
| Study group | Role | What they receive |
|---|---|---|
| Qualia Perimenopause Formula A | Experimental | Not described Receives: Dietary Supplement: Qualia Perimenopause Formula A |
| Qualia Perimenopause Formula B | Experimental | Not described Receives: Dietary Supplement: Qualia Perimenopause Formula B |
| Qualia Perimenopause Formula C | Experimental | Not described Receives: Dietary Supplement: Qualia Perimenopause Formula C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 28
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Day 33 (5-7 days after final dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start16 Mar 2026
- Primary completion22 Apr 2026
- Study completion27 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-menopausal WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qualia Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361757
- Sponsor's protocol ID
- QLS-021
- Status last verified
- Oct 2026
- First submitted
- 15 Jan 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualia Perimenopause Efficacy and Tolerability Study: An Open-label 3-Arm Trial
- ClinicalTrials.gov ID
- NCT07361757
- Acronym / sponsor ID
- QLS-021
- Conditions
- Peri-menopausal Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Qualia Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 22 Apr 2026 (actual)
- Study completion
- 27 Apr 2026 (actual)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualia Perimenopause Formula AQualia 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). | Dietary supplement | Qualia Perimenopause Formula A |
| Qualia Perimenopause Formula BQualia 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). | Dietary supplement | Qualia Perimenopause Formula B |
| Qualia Perimenopause Formula CQualia 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). | Dietary supplement | Qualia Perimenopause Formula C |
Primary outcome
Menopause Rating Scale (MRS) - Total Score
Time frame: Day 28
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.
7 secondary outcomes
PROMIS Cognitive Function v2.0 - Short Form 8a
Time frame: Day 14, Day 28
Safety and Tolerability Survey
Time frame: Day 14, Day 28
PROMIS Sleep Disturbance - Short Form
Time frame: Day 14, Day 28
MRS Psychological Subdomain
Time frame: Day 14, Day 28
MRS Somato-Vegetative Subdomain
Time frame: Day 14, Day 28
MRS Urogenital Subdomain
Time frame: Day 14, Day 28
Follow-up Questionnaire
Time frame: Day 33 (5-7 days after final dose)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qualia Perimenopause Formula A, Qualia Perimenopause Formula B and Qualia Perimenopause Formula C in people with Peri-menopausal Women, run by Qualia Life Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menopause Rating Scale (MRS) - Total Score (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.