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

NCT06889753 | Recruiting Phase 2

• 1 other identifier: 24GXCFG01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menopausal Women

Keywords

Menopause; Flower Pollen Extracts; Water Soluble Pollen Extract; Lipid Soluble Pollen Extract

Outcome Measures

Primary Outcomes (1)

• The difference in change in severity of menopausal symptomsbaseline at Week 36 between Graminex WSPE, Graminex LSPE, and Placebo

  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 WSPE, Graminex LSPE, and Placebo.

  Week 0 (baseline) to 36

Secondary Outcomes (15)

• The difference in change in severity of menopausal symptoms from baseline at Week 6 between Graminex WSPE, Graminex LSPE, and Placebo

  Week 0 (baseline) to 6

• The difference in change in severity of menopausal symptoms from baseline at Week 12 between Graminex WSPE, Graminex LSPE, and Placebo

  Week 0 (baseline) to 12

• The difference in change in severity of menopausal symptoms from baseline at Week 24 between Graminex WSPE, Graminex LSPE, and Placebo

  Week 0 (baseline) to 24

• The difference in change in scores of individual domains of the MRS including Somatic, Psychological, and Urogenital domains between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 6

  Week 0 (baseline) to 6

• The difference in change in scores of individual domains of the MRS including Somatic, Psychological, and Urogenital domains between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 12

  Week 0 (baseline) to 12

Other Outcomes (5)

• Incidence of post-emergent adverse events (AE)

  Week 0 (baseline) to 36

• Clinically relevant changes in blood pressure (BP) after supplementation

  Week 0 (baseline) to 36

• Clinically relevant changes in blood pressure (BP) after supplementation

  Week 0 (baseline) to 36

Study Arms (3)

Graminex Water Soluble Pollen Extract (WSPE)

EXPERIMENTAL

Graminex WSPE is a water soluble extract from flower pollen standardized to 6% amino acids.

Dietary Supplement: Graminex WSPE

Graminex Lipid Soluble Pollen Extract (LSPE)

EXPERIMENTAL

Graminex LSPE is a lipid soluble pollen extract standardized to 7% phytosterols.

Dietary Supplement: Graminex LSPE

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Graminex WSPE DIETARY_SUPPLEMENT

Graminex Water Soluble Pollen Extract is standardized to 6% amino acids.

Graminex Water Soluble Pollen Extract (WSPE)

Graminex LSPE DIETARY_SUPPLEMENT

Graminex Lipid Soluble Pollen Extract is standardized to 7% phytosterols.

Graminex Lipid Soluble Pollen Extract (LSPE)

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Graminex LLC: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6B3L1, Canada

RECRUITING

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Lewiss, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 21, 2025
• Study Start: October 29, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)