Menopausal WomenPhase 2NCT06889753
A Clinical Trial to Investigate the Effect of Pollen Extracts on Menopausal Symptoms in Healthy Women.
A Phase 2 study testing Graminex WSPE and Graminex LSPE in people with Menopausal Women, run by Graminex LLC at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopausal Women
- What is being tested?
- Graminex WSPE and Graminex LSPE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 29 Oct 2025to Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 25Show fewer
- 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
- 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 baseline, as assessed by the QI
- Individuals who are unable to give informed consent
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
KGK Science Inc.
London, Ontario, N6B3L1
Erin Lewis, PhD, 2262424551 ext. 248, elewis@kgkscience.com
David Crowley, MD
About this study
Official title: A Randomized, Triple-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Effect of Pollen Extracts on Menopausal Symptoms in Healthy Women.
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
- Being tested
- Graminex WSPE, Graminex LSPE, Placebo
- Keywords
- Menopause, Flower Pollen Extracts, Water Soluble Pollen Extract, Lipid Soluble Pollen Extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graminex WSPEDietary supplement
Graminex Water Soluble Pollen Extract is standardized to 6% amino acids.
Graminex LSPEDietary supplement
Graminex Lipid Soluble Pollen Extract is standardized to 7% phytosterols.
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Graminex Water Soluble Pollen Extract (WSPE) | Experimental | Graminex WSPE is a water soluble extract from flower pollen standardized to 6% amino acids. Receives: Dietary Supplement: Graminex WSPE |
| Graminex Lipid Soluble Pollen Extract (LSPE) | Experimental | Graminex LSPE is a lipid soluble pollen extract standardized to 7% phytosterols. Receives: Dietary Supplement: Graminex LSPE |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The difference in change in severity of menopausal symptoms as assessed by total MRS score from baseline at Week 6 between Graminex WSPE, Graminex LSPE, and Placebo.
Measured: 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
The difference in change in severity of menopausal symptoms as assessed by total MRS score from baseline at Week 12 between Graminex WSPE, Graminex LSPE, and Placebo.
Measured: 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
The difference in change in severity of menopausal symptoms as assessed by total MRS score from baseline at Week 24 between Graminex WSPE, Graminex LSPE, and Placebo.
Measured: 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
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.
Measured: 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
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.
Measured: Week 0 (baseline) to 12
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 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 24.
Measured: 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 36
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 36.
Measured: Week 0 (baseline) to 36
The difference in change in scores of individual symptoms included in the MRS between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 6
The difference in change in scores of individual symptoms included in the MRS between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 6.
Measured: Week 0 (baseline) to 6
The difference in change in scores of individual symptoms included in the MRS between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 12
The difference in change in scores of individual symptoms included in the MRS between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 12.
Measured: Week 0 (baseline) to 12
The difference in change in scores of individual symptoms included in the MRS between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 24.
The difference in change in scores of individual symptoms included in the MRS between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 24.
Measured: Week 0 (baseline) to 24
The difference in change in scores of individual symptoms included in the MRS between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 36
The difference in change in scores of individual symptoms included in the MRS between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 36
Measured: Week 0 (baseline) to 36
The difference in change in sleep disturbance between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 6
The difference in change in sleep disturbance as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance form 8b between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 6
Measured: Week 0 (baseline) to 6
The difference in change in sleep disturbance between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 12
The difference in change in sleep disturbance as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance form 8b between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 12.
Measured: Week 0 (baseline) to 12
The difference in change in sleep disturbance between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 24
The difference in change in sleep disturbance as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance form 8b between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 24.
Measured: Week 0 (baseline) to 24
The difference in change in sleep disturbance between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 36
The difference in change in sleep disturbance as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance form 8b between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 36.
Measured: Week 0 (baseline) to 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start29 Oct 2025
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopausal WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Graminex LLC
- Sponsor type
- University, hospital or other
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889753
- Sponsor's protocol ID
- 24GXCFG01
- Status last verified
- Jul 2026
- First submitted
- 17 Mar 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Triple-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Effect of Pollen Extracts on Menopausal Symptoms in Healthy Women.
- ClinicalTrials.gov ID
- NCT06889753
- Acronym / sponsor ID
- 24GXCFG01
- Conditions
- Menopausal Women
- Keywords
- Menopause, Flower Pollen Extracts, Water Soluble Pollen Extract, Lipid Soluble Pollen Extract
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Graminex LLCUniversity, hospital or other
- Collaborators
- KGK Science Inc.
- Study start
- 29 Oct 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Graminex Water Soluble Pollen Extract (WSPE) | Experimental | Dietary Supplement: Graminex WSPEGraminex WSPE is a water soluble extract from flower pollen standardized to 6% amino acids. |
| Graminex Lipid Soluble Pollen Extract (LSPE) | Experimental | Dietary Supplement: Graminex LSPEGraminex LSPE is a lipid soluble pollen extract standardized to 7% phytosterols. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graminex WSPEGraminex Water Soluble Pollen Extract is standardized to 6% amino acids. | Dietary supplement | Graminex Water Soluble Pollen Extract (WSPE) |
| Graminex LSPEGraminex Lipid Soluble Pollen Extract is standardized to 7% phytosterols. | Dietary supplement | Graminex Lipid Soluble Pollen Extract (LSPE) |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
The difference in change in severity of menopausal symptomsbaseline at Week 36 between Graminex WSPE, Graminex LSPE, and Placebo
Time frame: Week 0 (baseline) to 36
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.
15 secondary outcomes
The difference in change in severity of menopausal symptoms from baseline at Week 6 between Graminex WSPE, Graminex LSPE, and Placebo
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 0 (baseline) to 12
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 24
Time frame: 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 36
Time frame: Week 0 (baseline) to 36
The difference in change in scores of individual symptoms included in the MRS between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 6
Time frame: Week 0 (baseline) to 6
The difference in change in scores of individual symptoms included in the MRS between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 12
Time frame: Week 0 (baseline) to 12
The difference in change in scores of individual symptoms included in the MRS between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 24.
Time frame: Week 0 (baseline) to 24
The difference in change in scores of individual symptoms included in the MRS between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 36
Time frame: Week 0 (baseline) to 36
The difference in change in sleep disturbance between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 6
Time frame: Week 0 (baseline) to 6
The difference in change in sleep disturbance between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 12
Time frame: Week 0 (baseline) to 12
The difference in change in sleep disturbance between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 24
Time frame: Week 0 (baseline) to 24
The difference in change in sleep disturbance between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 36
Time frame: Week 0 (baseline) to 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Crowley, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Graminex WSPE and Graminex LSPE in people with Menopausal Women, run by Graminex LLC at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Lewiss, PhD (1-226-242-4551 ext. 248, elewis@kgkscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in change in severity of menopausal symptomsbaseline at Week 36 between Graminex WSPE, Graminex LSPE, and Placebo (time frame: Week 0 (baseline) to 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.