Actively Recruiting
A Randomized, Triple-blind, Placebo Controlled, Parallel 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
N/A
Total Duration
On this page
Sponsors
G
Graminex LLC
Lead Sponsor
K
KGK Science Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial studies the effect of pollen extracts on menopausal symptoms in healthy women aged 45 to 65 years who experience moderate menopausal symptoms. It aims to compare changes in symptom severity measured by the Menopause Rating Scale (MRS) over 36 weeks among women taking Graminex Water Soluble Pollen Extract (WSPE), Graminex Lipid Soluble Pollen Extract (LSPE), or a placebo. The study is a randomized, triple-blind, placebo-controlled clinical trial sponsored by Graminex LLC. Participants will be randomly assigned to receive either WSPE standardized to 6% amino acids, LSPE standardized to 7% phytosterols, or a placebo. These dietary supplements will be taken over a 36-week period, during which menopausal symptoms will be tracked. The trial includes assessment at multiple timepoints to monitor changes in overall menopausal symptom severity as well as specific symptom domains such as somatic, psychological, and urogenital symptoms. Throughout the study, participants will complete the MRS questionnaire to rate their menopausal symptoms at baseline and at weeks 6, 12, 24, and 36. Researchers will evaluate symptom changes to understand the differences between the pollen extracts and placebo. The study also monitors sleep disturbance changes and includes safety assessments. Participation involves regular study visits and symptom assessments over the 36-week treatment period.
CONDITIONS
Brief 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...
- Females between 45-60 years of age, inclusive
- Body mass index (BMI) between 18.5 and 34.9 inclusive
- Self-reported menopausal women with no menstrual period for over 12 months before screening
- Experiencing moderate menopausal symptoms with a Menopause Rating Scale score of 9 or higher at screening
- Menopausal symptoms present for at least six months, including vasomotor symptoms and at least two other symptoms such as sleep disturbance, joint pain, mood changes, fatigue, vaginal dryness, urinary changes, or sexual function changes
- Agree 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 or sensitivity to bee products, pollen, or ingredients in the investigational products or placebo
- Ongoing diagnosis of anxiety disorder, sleep disorder, or major depression
- Unstable musculoskeletal disorders
- Current untreated urogenital diagnosis
- Unstable metabolic or chronic diseases
- Significant gastrointestinal diseases
- Unstable hypertension unless on stable medication for at least 3 months
- Unstable Type I or Type II diabetes
- Significant cardiovascular event in past six months unless stabilized on medication
- History or current diagnosis of kidney or liver diseases except symptom-free kidney stones
- Current or pre-existing thyroid condition unless on stable medication for at least 3 months
- Major surgery in past three months or planned surgery during study
- Cancer except fully excised basal cell carcinoma or cancer in remission over five years
- Unstable autoimmune disease or immune compromise
- Use or chronic use of medical cannabinoid products
- Alcohol intake averaging more than 2 standard drinks per day
- Alcohol or drug abuse in last 12 months
- Use of medications, supplements, or foods that may affect investigational product
- Participation in other clinical trials within 30 days prior to baseline
- Unable to give informed consent
- Any condition or lifestyle factor that may affect study completion or safety
- Asthma as assessed by the Qualified Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 36 weeks
Participants receive either Graminex Water Soluble Pollen Extract, Graminex Lipid Soluble Pollen Extract, or a placebo to investigate effects on menopausal symptoms.
Regular assessments throughout 36 weeks
Trial Site Locations
Total: 1 location
1
KGK Science Inc.
London, Ontario, Canada, N6B3L1
Actively Recruiting
Research Team
E
Erin Lewiss, PhD
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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