Pollen extracts for menopausal symptom relief

A Randomized, Triple-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Effect of Pollen Extracts on Menopausal Symptoms in Healthy Women.

This trial tests whether two types of Graminex pollen extract (water-soluble or lipid-soluble) reduce menopausal symptoms compared with placebo in healthy women aged 45–60 who have been menopausal for more than 12 months.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 45 Years to 65 Years
• Sex: Female
• Sponsor: Graminex LLC (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (London, Ontario)
• Trial ID: NCT06889753 on ClinicalTrials.gov

What this trial studies

Healthy women aged 45–60 who have been menopausal for over 12 months and report at least moderate symptoms (MRS ≥9) will receive either Graminex water-soluble pollen extract (WSPE), Graminex lipid-soluble pollen extract (LSPE), or placebo for the study period. Participants will complete the Menopause Rating Scale (MRS) at baseline and at Week 36, with the primary outcome being the change in total MRS score from baseline to Week 36. This is an interventional Phase 2 study sponsored by Graminex LLC and conducted at KGK Science Inc. in London, Ontario. Eligibility includes BMI 18.5–34.9 kg/m2 and at least six months of menopausal symptoms prior to screening.

Who should consider this trial

Good fit: Ideal candidates are women 45–60 years old who have been menopausal for more than 12 months, have an MRS total score ≥9, have a BMI of 18.5–34.9, and are otherwise healthy.

Not a fit: Women who are not postmenopausal for at least 12 months, have only mild symptoms (MRS <9), fall outside the specified age or BMI ranges, or have unstable medical conditions are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, one of the pollen extracts could provide a non-hormonal option to reduce menopausal symptoms.

How similar studies have performed: Some small prior studies and preliminary reports have suggested pollen extracts or related botanicals may help menopausal symptoms, but large, well-controlled trials are limited.

Eligibility criteria

Inclusion Criteria:

1. Females between 45-60 years of age, inclusive
2. BMI 18.5 kg/m2 - 34.9 kg/m2 inclusive
3. Self-reported menopausal women who have not had a menstrual period for \>12 months prior to screening and are experiencing at least moderate menopausal symptoms as assessed by the total MRS score of ≥9 at screening
4. Presence of menopausal symptoms for at least six months prior to screening including, vasomotor symptoms (hot flushes, sweating) AND at least two of the following symptoms: sleep disturbance, joint pain, mood changes, fatigue and lack of energy, vaginal dryness, urinary changes, and changes in sexual function
5. Agrees to maintain current lifestyle as much as possible throughout the study, including diet, exercise, medications, dietary supplements, and sleep
6. Able and willing to complete all study assessments
7. Provided voluntary, written, informed consent to participate in the study
8. Healthy as determined by medical history with no unstable, diagnosed medical conditions as assessed by the Qualified Investigator (QI)

Exclusion Criteria:

1. Females who have had unilateral oophorectomy or hysterectomy or uterine ablation
2. Allergy (including bee products or pollen, sensitivity, or intolerance to investigational products or placebo ingredients
3. Ongoing diagnosis with anxiety disorder, sleep disorder, or major depression as assessed by the QI
4. Ongoing unstable diagnosis of musculoskeletal disorders as assessed by the QI
5. Current untreated urogenital diagnosis as assessed by the QI
6. Unstable metabolic disease or chronic diseases as assessed by the QI
7. Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
8. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
9. Current unstable Type I or Type II diabetes
10. Significant cardiovascular event in the past six months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
11. History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
12. Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least three months will be considered by the QI
13. Major surgery in the past three months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
14. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years
15. after diagnosis are acceptable
16. Individuals with unstable autoimmune disease or are immune compromised as assessed by the QI
17. Use of medical cannabinoid products
18. Chronic use of cannabinoid products (\>2 times/week) as assessed by the QI
19. Alcohol intake average of \>2 standard drinks per day as assessed by the QI
20. Alcohol or drug abuse within the last 12 months
21. Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy of the investigational product (Sections 7.3.1 and 7.3.2)
22. Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
23. Individuals who are unable to give informed consent
24. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
25. Asthmatic, as assessed by the QI

Where this trial is running

London, Ontario

• KGK Science Inc. — London, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: David Crowley, MD — KGK Science Inc.
• Study coordinator: Erin Lewiss, PhD

Conditions: Menopausal Women, Menopause, Flower Pollen Extracts, Water Soluble Pollen Extract, Lipid Soluble Pollen Extract