MenopauseNCT07903480
A Clinical Trial to Evaluate the Effects of A Supplement on Symptoms of Menopause and Overall Well-being
A study testing Primal Meno+ Supplement in people with Menopause and Menopausal Symptoms, run by Primal Harvest, LLC at 1 site in United States.
Trial summary
This study evaluates the effects of Primal Harvest's Primal Meno+ supplement on symptoms of menopause and overall well-being in females aged 40-60 who are currently menopausal and experiencing at least two menopausal symptoms. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Menopause, Menopausal Symptoms, Hot Flashes
- What is being tested?
- Primal Meno+ Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Be female.
- Be aged 40-60.
- Anyone who is currently menopausal and experiencing at least two of the following symptoms of menopause: hot flashes
- night sweats
- sleep disturbances (e.g., insomnia, trouble falling asleep, staying asleep, or experiencing restless or disrupted sleep)
- mood changes (e.g., mood swings, irritability, increased anxiety, feelings of sadness or depression)
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- fatigue and lack of energy.
- Anyone who is generally healthy - does not live with any uncontrolled chronic disease.
- If taking oral over-the-counter supplements or herbal remedies targeted at symptoms of menopause, has been consistently taking these for at least 3 months prior to starting the study, and is willing to maintain this routine for the study duration.
- Not planning on introducing any products or any new forms of prescription medication or supplements that target symptoms of menopause for the study duration.
- Resides in the United States.
- Willing to maintain the same diet and exercise regimen consistently throughout the study duration.
Who cannot join
- Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- Anyone with any allergies or sensitivities to any of the study product ingredients.
- Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period).
- Anyone unwilling to follow the study protocol.
- Anyone who is currently taking or planning to take, during the study period, any hormone replacement therapy (HRT).
- Anyone with a history of uterine fibroids, endometriosis, polycystic ovarian syndrome, or abnormal pap smears.
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- Anyone who is a heavy drinker (i.e., eight or more alcoholic drinks per week for women).
- Anyone with a history of substance abuse.
- Currently partaking in another research study or will be partaking in any other research study at any point during this study's duration.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study evaluates the effects of Primal Harvest's Primal Meno+ supplement on symptoms of menopause and overall well-being in females aged 40-60 who are currently menopausal and experiencing at least two menopausal symptoms. Over a 12-week period, 40 participants will take one capsule of the test product daily with their first meal of the day.
Participants will complete self-reported questionnaires at Baseline, Week 4, Week 8, and Week 12 to assess menopausal symptoms (including hot flashes, night sweats, sleep quality, stress resilience, and emotional well-being) and overall health and well-being. This is a single-arm, open-label, virtual trial with no randomization or blinding.
- Conditions
- Menopause, Menopausal Symptoms, Hot Flashes, Night Sweats, Sleep Disturbance, Mood Changes
- Being tested
- Primal Meno+ Supplement
- Medical subject headings
- Hot Flashes, Parasomnias, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primal Meno+ SupplementDietary supplement
All 40 participants take one capsule of Primal Meno+ daily with their first meal of the day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Primal Meno+ Supplement | Experimental | Not described Receives: Dietary Supplement: Primal Meno+ Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Symptoms of Menopause
Assessed via the Menopausal Rating Scale (MRS) validated self-reported questionnaire
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Hot Flashes
Assessed via self-reported questionnaire
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Night Sweats
Assessed via self-reported questionnaire
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Stress Resilience
Assessed via self-reported questionnaire
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Sleep Quality
Assessed via self-reported questionnaire
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Emotional Well-being
Assessed via self-reported questionnaire
Measured: Baseline, Week 4, Week 8, and Week 12
Secondary outcomes (9)
Change in Mood
Assessed via self-reported questionnaire
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Night Sweats
Assessed via self-reported questionnaire
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Stress Resilience
Assessed via self-reported questionnaire
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Fatigue
Assessed via self-reported questionnaire
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Quality of Life
Assessed via self-reported questionnaire
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Hot Flashes
Assessed via self-reported questionnaire
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Sleep Quality
Assessed via self-reported questionnaire
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Emotional Well-being
Assessed via self-reported questionnaire
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Overall Health and Well-being
Assessed via self-reported questionnaire
Measured: Baseline, Week 4, Week 8, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Primal Harvest, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903480
- Sponsor's protocol ID
- #PRIMA-18141
- Other IDs
- legacy-_PRIMA-18141
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Effects of A Supplement on Symptoms of Menopause and Overall Well-being
- ClinicalTrials.gov ID
- NCT07903480
- Acronym / sponsor ID
- #PRIMA-18141
- Conditions
- Menopause, Menopausal Symptoms, Hot Flashes, Night Sweats, Sleep Disturbance, Mood Changes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Primal Harvest, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Oct 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 study evaluates the effects of Primal Harvest's Primal Meno+ supplement on symptoms of menopause and overall well-being in females aged 40-60 who are currently menopausal and experiencing at least two menopausal symptoms. Over a 12-week period, 40 participants will take one capsule of the test product daily with their first meal of the day.
Participants will complete self-reported questionnaires at Baseline, Week 4, Week 8, and Week 12 to assess menopausal symptoms (including hot flashes, night sweats, sleep quality, stress resilience, and emotional well-being) and overall health and well-being. This is a single-arm, open-label, virtual trial with no randomization or blinding.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primal Meno+ Supplement | Experimental | Dietary Supplement: Primal Meno+ Supplement |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Be female.
- Be aged 40-60.
- Anyone who is currently menopausal and experiencing at least two of the following symptoms of menopause: hot flashes
- night sweats
- sleep disturbances (e.g., insomnia, trouble falling asleep, staying asleep, or experiencing restless or disrupted sleep)
Key exclusion criteria (9 listed)
- Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- Anyone with any allergies or sensitivities to any of the study product ingredients.
- Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period).
- Anyone unwilling to follow the study protocol.
- Anyone who is currently taking or planning to take, during the study period, any hormone replacement therapy (HRT).
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 |
|---|---|---|
| Primal Meno+ SupplementAll 40 participants take one capsule of Primal Meno+ daily with their first meal of the day for 12 weeks. | Dietary supplement | Primal Meno+ Supplement |
Primary outcome
Change in Symptoms of Menopause
Time frame: Baseline, Week 4, Week 8, and Week 12
Assessed via the Menopausal Rating Scale (MRS) validated self-reported questionnaire
Change in Hot Flashes
Time frame: Baseline, Week 4, Week 8, and Week 12
Assessed via self-reported questionnaire
Change in Night Sweats
Time frame: Baseline, Week 4, Week 8, and Week 12
Assessed via self-reported questionnaire
Change in Stress Resilience
Time frame: Baseline, Week 4, Week 8, and Week 12
Assessed via self-reported questionnaire
Change in Sleep Quality
Time frame: Baseline, Week 4, Week 8, and Week 12
Assessed via self-reported questionnaire
Change in Emotional Well-being
Time frame: Baseline, Week 4, Week 8, and Week 12
Assessed via self-reported questionnaire
9 secondary outcomes
Change in Mood
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Night Sweats
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Stress Resilience
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Fatigue
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Quality of Life
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Hot Flashes
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Sleep Quality
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Emotional Well-being
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Overall Health and Well-being
Time frame: Baseline, Week 4, Week 8, and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primal Meno+ Supplement in people with Menopause and Menopausal Symptoms, run by Primal Harvest, LLC 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 12 inclusion and 9 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: opening soon, as of the sponsor's last update on 29 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Renner (42424250284, hello@citruslabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Symptoms of Menopause (time frame: Baseline, Week 4, Week 8, and Week 12). The study lists 6 primary outcomes in all. 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 29 Oct 2026.