Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Canada / NCT06889753
Recruiting Phase 2

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

NCT06889753 · tracked via the Priya Life Science Canada tracker
Sponsor
Graminex LLC
Phase
Phase 2
Started
2025-10-29
Last updated
2026-07-08

Condition(s) studied

Menopausal Women

Investigational drug(s) / intervention(s)

Graminex WSPEGraminex LSPEPlacebo

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

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

Placebo: Placebo

Study 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

Sex
FEMALE
Min age
45 Years
Max age
65 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
KGK Science Inc. London Ontario Recruiting
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 NCT06889753 on ClinicalTrials.gov ↗ ← All trials in Canada