Ireland
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Starting soon Not applicable

A Clinical Trial to Evaluate the Effects of A Supplement on Symptoms of Menopause and Overall Well-being

NCT07903480 · tracked via the Priya Life Science USA tracker
Sponsor
Primal Harvest, LLC
Phase
Not applicable
Started
2026-10
Last updated
2026-10-29

Condition(s) studied

MenopauseMenopausal SymptomsHot FlashesNight SweatsSleep DisturbanceMood ChangesFatigue

Investigational drug(s) / intervention(s)

Primal Meno+ Supplement

Primal Meno+ Supplement: All 40 participants take one capsule of Primal Meno+ daily with their first meal of the day for 12 weeks.

Study 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. 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.

Eligibility

Sex
FEMALE
Min age
40 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: * 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) * 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. Exclusion Criteria: * 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. * 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.

Primary outcome measure(s)

  • Change in Symptoms of Menopause — Baseline, Week 4, Week 8, and Week 12
    Assessed via the Menopausal Rating Scale (MRS) validated self-reported questionnaire
  • Change in Hot Flashes — Baseline, Week 4, Week 8, and Week 12
    Assessed via self-reported questionnaire
  • Change in Night Sweats — Baseline, Week 4, Week 8, and Week 12
    Assessed via self-reported questionnaire
  • Change in Stress Resilience — Baseline, Week 4, Week 8, and Week 12
    Assessed via self-reported questionnaire
  • Change in Sleep Quality — Baseline, Week 4, Week 8, and Week 12
    Assessed via self-reported questionnaire
  • Change in Emotional Well-being — Baseline, Week 4, Week 8, and Week 12
    Assessed via self-reported questionnaire

Trial sites (1)

FacilityCityRegionStatus
Citruslabs Las Vegas Nevada
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07903480 on ClinicalTrials.gov ↗ ← All trials in the USA