A Clinical Trial to Investigate the Effect of Pollen Extracts on Menopausal Symptoms in Healthy Women.

What this trial studies

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 in scope

• Menopausal Women

Interventions

• Graminex WSPE (Dietary Supplement) — Graminex Water Soluble Pollen Extract is standardized to 6% amino acids.
• Graminex LSPE (Dietary Supplement) — Graminex Lipid Soluble Pollen Extract is standardized to 7% phytosterols.
• Placebo (Dietary Supplement) — Placebo

Who can join

Women only · Ages 45 Years to 65 Years · Accepts healthy volunteers.

Inclusion criteria

• 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)

Exclusion criteria

• 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
• 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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: PHASE2
• Start date: 2025-10-29
• Primary completion: 2026-08
• Last update posted: 2025-11-19
• First posted: 2025-03-21

Sponsor & contact

Lead sponsor: Graminex LLC (Other)

Collaborators: KGK Science Inc.

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• The difference in change in severity of menopausal symptomsbaseline at Week 36 between Graminex WSPE, Graminex LSPE, and Placebo (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.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.