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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how pollen extracts might relieve menopause symptoms, such as hot flashes and mood changes. The study compares two types of pollen extracts, Graminex WSPE (water-soluble pollen extract) and Graminex LSPE (lipid-soluble pollen extract), against a placebo to determine which is most effective in reducing these symptoms. Women who haven't had their period for over a year and experience moderate menopause symptoms may be suitable for this study. Participants will provide feedback on their symptoms throughout the trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that pollen extract treatments, like those in this study, are generally safe. Most treatments do not cause reactions. In some cases, mild side effects may occur, but these are usually not serious.

The pollen extracts used in this trial withstand digestion and heat, allowing them to pass through the body without breaking down. This reduces the risk of side effects.

Since this study is in Phase 2, earlier studies have already provided some evidence of safety. While specific details on side effects are not available here, the continued testing of these extracts suggests they are generally well-tolerated. Based on past research, participants in this trial can reasonably expect the treatments to be safe. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Graminex LSPE and WSPE because these treatments offer a unique approach to managing menopause symptoms. Unlike traditional hormone replacement therapies, which often involve synthetic hormones, Graminex extracts are derived from flower pollen. LSPE is rich in phytosterols, while WSPE contains a high concentration of amino acids, both potentially offering a natural alternative to hormone-based treatments. This could provide a safer option for individuals who are unable to use standard hormone therapies or prefer natural remedies.

What evidence suggests that this trial's treatments could be effective for menopausal symptoms?

Studies have shown that pollen extracts can significantly ease menopausal symptoms. A similar pollen extract, Sérélys®, reduced hot flashes, sleep problems, and mood swings. In this trial, participants will receive either Graminex LSPE or WSPE, both studied for their potential to affect hormones and reduce these symptoms. Previous studies on pollen extracts have also reported less irritability, tiredness, and vaginal dryness. These findings suggest that Graminex LSPE and WSPE may improve overall comfort during menopause. ^{1 2 3 5 6}

Who Is on the Research Team?

David Crowley, MD

Principal Investigator

KGK Science Inc.

Are You a Good Fit for This Trial?

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

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

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06889753

A Clinical Trial to Investigate the Effect of Pollen Extracts on ... 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:.

2. trial.medpath.com trial.medpath.com/clinical-trial/10f631d804f0b951/nct06889753-pollen-extracts-menopause-symptoms

A Clinical Trial to Investigate the Effect of Pollen Extracts on ... 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.

3. withpower.com withpower.com/trial/phase-2-menopausal-women-6-2025-fecbc

Pollen Extracts for Menopause · Info for Participants A study on a similar pollen extract, Sérélys®, showed it significantly reduced menopausal symptoms like hot flashes, sleep disturbances, and mood swings, with a ...

4. kgkscience.com kgkscience.com/menopause-symptoms-in-women-natural-relief-study/

Menopause Symptoms in Women- Natural Relief Study Previous studies on pollen extract have shown meaningful reduction in hot flashes, sleep disturbances, mood, irritability, fatigue, vaginal dryness, and muscle ...

5. graminex.com graminex.com/wp-content/uploads/2017/11/Findings-on-Female-Menopausal-Disorders-through-the-Pollen-Extract-G63-of-Graminex-Company.pdf

Findings on Female Menopausal Disorders through the “ ... Here, we have examined the influence of pollen extract G63 on hormones and improvement of the associated indeterminate complaints. Objective and Methods. Six ...

6. graminex.com graminex.com/wp-content/uploads/2017/11/Graminex-Flower-Pollen-Extract-A-microbiological-digest.pdf

Graminex® Flower Pollen Extract™ - A microbiological digest Graminex is currently the only manufacturer using non solvent technology to produce Flower Pollen Extracts eliminating residual solvents in the final product.