Testing Graminex WSPE against a placebo for menopausal women
Official title: 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.
- Phase 2
- 3 groups
- One site, in London
- Recruiting
Interventions
- Other intervention
Graminex WSPE
Graminex Water Soluble Pollen Extract is standardized to 6% amino acids.
- Other intervention
Graminex LSPE
Graminex Lipid Soluble Pollen Extract is standardized to 7% phytosterols.
- Other intervention
Placebo
Placebo
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
KGK Science Inc.
London, Ontario
Eligibility Criteria
See who this study is looking for33 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more → 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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → to participate in the study
- +Healthy as determined by medical history with no unstable, diagnosed medical conditions as assessed by the Qualified InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → (QI)
Exclusion
- −Allergy (including bee products or pollen, sensitivity, or intolerance to investigational products or placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → ingredients
- −Females who have had unilateral oophorectomy or hysterectomy or uterine ablation
- −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
- −after diagnosis are acceptable
- −Individuals with unstable autoimmune disease or are immune compromised as assessed by the QI
- −Use of medical cannabinoid products
- −Chronic use of cannabinoid products (\>2 times/week) as assessed by the QI
- −Alcohol intake average of \>2 standard drinks per day as assessed by the QI
- −Alcohol or drug abuse within the last 12 months
- −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)
- −Participation in other clinical research studies 30 days prior to baselineBaselineYour starting measurements, taken before treatment begins.Read more →, as assessed by the QI
- −Individuals who are unable to give informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- −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
- −Asthmatic, as assessed 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 upFollow-upContinued check-ins after the treatment part is finished.Read more → that is negative. Volunteers with cancer in full remission for more than five years
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Group A receives Graminex WSPE.
Registry label: A: Graminex Water Soluble Pollen Extract (WSPE)
Group B receives Graminex LSPE.
Registry label: B: Graminex Lipid Soluble Pollen Extract (LSPE)
Group C, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.
Registry label: C: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 45 years to 65 years.
The study lists female participants only.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 120 people.
The study is currently expected to finish around August 2026.
The main measurement is taken over: Week 0 (baselineBaselineYour starting measurements, taken before treatment begins.Read more →) to 36.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
The difference in change in severity of menopausal symptomsbaseline at Week 36 between Graminex WSPE, Graminex LSPE, and PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — measured over Week 0 (baselineBaselineYour starting measurements, taken before treatment begins.Read more →) to 36.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06889753 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Graminex WSPEDietary supplement
Graminex Water Soluble Pollen Extract is standardized to 6% amino acids.
From the trial registry — its own words, unedited.
What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.
Read the full explanation → · in clinical review
About Graminex LSPEDietary supplement
Graminex Lipid Soluble Pollen Extract is standardized to 7% phytosterols.
From the trial registry — its own words, unedited.
What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.
Read the full explanation → · in clinical review
About PlaceboDietary supplement
Placebo
From the trial registry — its own words, unedited.
What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 45 years to 65 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 45 years to 65 years.
It lists female participants only.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Week 0 (baselineBaselineYour starting measurements, taken before treatment begins.Read more →) to 36.
The study as a whole is currently expected to finish around 2026-08.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 120 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: London, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About 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.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.