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

NCT06889753 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-11-19

No results posted yet for this study

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 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

Interventions

DIETARY_SUPPLEMENT

Graminex WSPE

Graminex Water Soluble Pollen Extract is standardized to 6% amino acids.

DIETARY_SUPPLEMENT

Graminex LSPE

Graminex Lipid Soluble Pollen Extract is standardized to 7% phytosterols.

DIETARY_SUPPLEMENT

Placebo

Placebo

Sponsors & Collaborators

  • KGK Science Inc.

    collaborator INDUSTRY

  • Graminex LLC

    lead OTHER

Principal Investigators

  • David Crowley, MD · KGK Science Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-29
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06889753 on ClinicalTrials.gov