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

RECRUITINGPHASE2

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

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

NCT06889753•Graminex LLC

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

45 - 65 years

Sex

FEMALE

Healthy Volunteers

Yes

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
+15 more criteria

Locations (1)

KGK Science Inc.

London, Ontario, Canada

Key Dates

Start Date

October 29, 2025

Primary Completion Date

August 1, 2026

Completion Date

August 1, 2026

Last Updated

November 19, 2025

Enrollment

120

ESTIMATED participants

Conditions

Menopausal Women

Interventions

Graminex WSPE

DIETARY_SUPPLEMENT

Graminex LSPE

DIETARY_SUPPLEMENT

Placebo

DIETARY_SUPPLEMENT

Contacts

Erin Lewiss, PhD

CONTACT

1-226-242-4551 elewis@kgkscience.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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