A Clinical Trial to Investigate the Effect of Pollen Extracts on Menopausal Symptoms in Healthy Women.

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Menopausal Women

In brief

The goal of this study is to investigate the effect of pollen extracts on menopausal symptoms in healthy women The main question it aims to answer is: What is the difference in change in severity of menopausal symptoms as assessed by the total Menopause Rating Scale (MRS) score from baseline at Week 36 between Graminex Water Soluble Pollen Extract (WSPE), Lipid Soluble Pollen Extract (LSPE), and Placebo? Participants will be asked to complete the MRS assessment tool to rate their menopausal symptoms while receiving either WSPE, LSPE, or Placebo.

Key facts

Study ID: NCT06889753
Run by: Graminex LLC
People needed: 120
Starts: 2025-10-29
Expected to finish: 2026-08-01
Last updated by the study team: 2026-07-08

Who can join

Age: 45 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

Females between 45-60 years of age, inclusive
BMI 18.5 kg/m2 - 34.9 kg/m2 inclusive
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
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
Agrees to maintain current lifestyle as much as possible throughout the study, including diet, exercise, medications, dietary supplements, and sleep
Able and willing to complete all study assessments
Provided voluntary, written, informed consent to participate in the study
Healthy as determined by medical history with no unstable, diagnosed medical conditions as assessed by the Qualified Investigator (QI)

You may not qualify if…

Females who have had unilateral oophorectomy or hysterectomy or uterine ablation
Allergy (including bee products or pollen, sensitivity, or intolerance to investigational products or placebo ingredients
Ongoing diagnosis with anxiety disorder, sleep disorder, or major depression as assessed by the QI
Ongoing unstable diagnosis of musculoskeletal disorders as assessed by the QI
Current untreated urogenital diagnosis as assessed by the QI
Unstable metabolic disease or chronic diseases as assessed by the QI
Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
Current unstable Type I or Type II diabetes
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
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
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
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
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
after diagnosis are acceptable
Individuals with unstable autoimmune disease or are immune compromised as assessed by the QI
Use of medical cannabinoid products
Chronic use of cannabinoid products (>2 times/week) as assessed by the QI
Alcohol intake average of >2 standard drinks per day as assessed by the QI
Alcohol or drug abuse within the last 12 months
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)
Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
Individuals who are unable to give informed consent
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
Asthmatic, as assessed by the QI

Where it is running

KGK Science Inc. — London, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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