Actively Recruiting
A Clinical Trial to Investigate the Effect of Pollen Extracts on Menopausal Symptoms in Healthy Women.
Led by Graminex LLC · Updated on 2025-11-19
120
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
G
Graminex LLC
Lead Sponsor
K
KGK Science Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Clinical Trial to Investigate the Effect of Pollen Extracts on Menopausal Symptoms in Healthy Women.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged between 45 and 60 years
- Body mass index (BMI) between 18.5 and 34.9 kg/m2
- Self-reported menopausal women with no menstrual period for over 12 months before screening
- Moderate menopausal symptoms with a total Menopause Rating Scale (MRS) score of 9 or higher at screening
- Menopausal symptoms present for at least six months, including vasomotor symptoms and at least two of the following: sleep disturbance, joint pain, mood changes, fatigue, vaginal dryness, urinary changes, or sexual function changes
- Willing to maintain current lifestyle, including diet, exercise, medications, supplements, and sleep during the study
- Able and willing to complete all study assessments
- Provided voluntary written informed consent
- Healthy with no unstable diagnosed medical conditions as assessed by the Qualified Investigator
You will not qualify if you...
- History of unilateral oophorectomy, hysterectomy, or uterine ablation
- Allergy, sensitivity, or intolerance to bee products, pollen, investigational products, or placebo ingredients
- Current diagnosis of anxiety disorder, sleep disorder, or major depression
- Ongoing unstable musculoskeletal disorders
- Untreated urogenital diagnosis
- Unstable metabolic or chronic diseases
- Significant gastrointestinal diseases
- Unstable hypertension (stable medication dose for at least 3 months considered case-by-case)
- Unstable Type I or II diabetes
- Significant cardiovascular event in past 6 months (stable medication may be considered case-by-case)
- Kidney or liver diseases (except symptom-free kidney stone history for 6 months)
- Current or pre-existing thyroid condition (stable medication dose for at least 3 months considered case-by-case)
- Major surgery in past 3 months or planned surgery during study (minor surgery considered case-by-case)
- Cancer except fully excised skin basal cell carcinoma or cancer in remission over 5 years
- Unstable autoimmune disease or immune compromise
- Use or chronic use of medical cannabinoid products
- Alcohol intake averaging over 2 standard drinks per day
- Alcohol or drug abuse within last 12 months
- Use of medications, supplements, or foods that may impact study product efficacy
- Participation in other clinical studies within 30 days prior to baseline
- Unable to give informed consent
- Any condition or lifestyle factor posing risk or affecting study completion
- Asthma as assessed by the Qualified Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
KGK Science Inc.
London, Ontario, Canada, N6B3L1
Actively Recruiting
Research Team
E
Erin Lewiss, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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