Pollen Extracts for Menopause

Overseen By Erin Lewiss, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Graminex LLC

Must not be taking: Cannabinoids, Alcohol

Disqualifiers: Cancer, Cardiovascular, Diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 36 weeks

120 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires participants to maintain their current medications as much as possible throughout the study. However, if you are taking medications, supplements, or consuming food/drinks that might affect the study's results, you may need to stop or adjust them as assessed by the Qualified Investigator.

What data supports the effectiveness of the treatment Graminex LSPE and Graminex WSPE for menopause?

A study on a similar pollen extract, Sérélys®, showed it significantly reduced menopausal symptoms like hot flashes, sleep disturbances, and mood swings, with a low risk of side effects, suggesting that Graminex LSPE and WSPE might offer similar benefits. ^{1 2 3 4 5}

Is pollen extract treatment generally safe for humans?

Pollen extract treatments, like those used for allergies, are generally safe for humans, with most injections not causing any reactions. Some people may experience mild local reactions, and women might be at a slightly higher risk for systemic reactions, but serious issues are rare. ^{6 7 8 9 10}

How is the treatment Graminex LSPE and WSPE unique for menopause?

Graminex LSPE and WSPE are unique for menopause treatment because they use pollen extracts, which offer a non-hormonal alternative to manage menopausal symptoms, potentially reducing side effects associated with hormone therapies. ^{1 2 4 11 12}

What is the purpose of this trial?

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.

Research Team

David Crowley, MD

Principal Investigator

KGK Science Inc.

Eligibility Criteria

This trial is for healthy women experiencing menopause. Specific eligibility details are not provided, but typically participants would need to be experiencing menopausal symptoms and meet certain health criteria.

Inclusion Criteria

I am a woman who hasn't had a period for over 12 months and have moderate menopausal symptoms.

I am willing and able to follow all study requirements.

Provided voluntary, written, informed consent to participate in the study

Exclusion Criteria

Allergy, sensitivity, or intolerance to investigational products or placebo ingredients

I have been diagnosed with anxiety, sleep disorder, or major depression.

Current untreated urogenital diagnosis as assessed by the QI

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Graminex Water Soluble Pollen Extract (WSPE), Lipid Soluble Pollen Extract (LSPE), or Placebo to assess changes in menopausal symptoms

36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Graminex LSPE
• Graminex WSPE
• Placebo

Trial Overview The study tests the effects of two types of pollen extracts (WSPE and LSPE) against a placebo on menopausal symptoms. Women will rate their symptoms using the Menopause Rating Scale over 36 weeks to see if there's any difference between the treatments.

Participant Groups

Group I: Graminex Water Soluble Pollen Extract (WSPE) Experimental Treatment 1 Intervention

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

Group II: Graminex Lipid Soluble Pollen Extract (LSPE) Experimental Treatment 1 Intervention

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

Group III: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Graminex LLC

Lead Sponsor

Trials

2

Recruited

310+

KGK Science Inc.

Industry Sponsor

Trials

82

Recruited

6,400+

Najla Guthrie

KGK Science Inc.

Chief Executive Officer since 1997

Research career at the Centre for Human Nutrition, University of Western Ontario

Dr. Bibiane Zakaria

KGK Science Inc.

Chief Medical Officer since 2023

MD from an unspecified institution

Findings from Research

In a study of 30 patients with grass pollen allergy, Nasonex (mometasone furoate) demonstrated significant efficacy in relieving symptoms of allergic rhinitis, with 24 patients experiencing complete or marked relief after treatment.

The treatment was well tolerated with no adverse reactions reported during the 2-week period, and it effectively reduced eosinophil levels in the nasal mucosa, indicating its mechanism of action in alleviating allergy symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The efficacy of a new medication -- intranasal glucocorticoid mometasone furoate (Nasonex) -- in seasonal allergic rhinitis]. Chyrek-Borowska, S., Rogalewska, AM., Lenczewska, D., et al.[2015]

References

1. England pubmed.ncbi.nlm.nih.gov

Prospective observational study to evaluate the efficacy and safety of the pollen extract Sérélys® in the management of women with menopausal symptoms. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a special extract of Rheum rhaponticum (ERr 731) in perimenopausal women with climacteric complaints: a 12-week randomized, double-blind, placebo-controlled trial. [2007]

3. Singapore pubmed.ncbi.nlm.nih.gov

The immediate effect of natural plant extract, Angelica sinensis and Matricaria chamomilla (Climex) for the treatment of hot flushes during menopause. A preliminary report. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Dose-Dependent Effects of the Cimicifuga racemosa Extract Ze 450 in the Treatment of Climacteric Complaints: A Randomized, Placebo-Controlled Study. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Soy germ extract alleviates menopausal hot flushes: placebo-controlled double-blind trial. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Oral hyposensitisation with enteric-coated allergens as extension therapy following a basic subcutaneous course of injections. [2019]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Critical appraisal of Timothy grass pollen extract GRAZAX in the management of allergic rhinitis. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Prospective survey of local and systemic reactions to immunotherapy with pollen extracts. [2004]

9. Poland pubmed.ncbi.nlm.nih.gov

[The efficacy of a new medication -- intranasal glucocorticoid mometasone furoate (Nasonex) -- in seasonal allergic rhinitis]. [2015]

10. England pubmed.ncbi.nlm.nih.gov

Pollinex Quattro Ragweed: safety evaluation of a new allergy vaccine adjuvanted with monophosphoryl lipid A (MPL) for the treatment of ragweed pollen allergy. [2012]

11. Poland pubmed.ncbi.nlm.nih.gov

Assessment of quality of life in women using Femelis Meno. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Confirmation of the efficacy of ERr 731 in perimenopausal women with menopausal symptoms. [2009]