A Clinical Trial to Investigate the Effect of Pollen Extracts on Menopausal Symptoms in Healthy Women.
Eligible age
45–65 yrs
Accepts
Women
Locations
0 states
Healthy volunteers
Yes
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About this study
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.
Sponsor: Graminex LLC
You may qualify if…
- ✓ 1. Females between 45-60 years of age, inclusive
- ✓ 2. BMI 18.5 kg/m2 - 34.9 kg/m2 inclusive
- ✓ 3. 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
- ✓ 4. 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
- ✓ 5. Agrees to maintain current lifestyle as much as possible throughout the study, including diet, exercise, medications, dietary supplements, and sleep
- ✓ 6. Able and willing to complete all study assessments
- ✓ 7. Provided voluntary, written, informed consent to participate in the study
- ✓ 8. Healthy as determined by medical history with no unstable, diagnosed medical conditions as assessed by the Qualified Investigator (QI)
You may not qualify if…
- ✕ 1. Females who have had unilateral oophorectomy or hysterectomy or uterine ablation
- ✕ 2. Allergy (including bee products or pollen, sensitivity, or intolerance to investigational products or placebo ingredients
- ✕ 3. Ongoing diagnosis with anxiety disorder, sleep disorder, or major depression as assessed by the QI
- ✕ 4. Ongoing unstable diagnosis of musculoskeletal disorders as assessed by the QI
- ✕ 5. Current untreated urogenital diagnosis as assessed by the QI
- ✕ 6. Unstable metabolic disease or chronic diseases as assessed by the QI
- ✕ 7. Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
- ✕ 8. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
Source: ClinicalTrials.gov · NCT06889753 · last updated 2026-07-08