Pollen Extracts for Menopause

Recruiting in Palo Alto (17 mi)

Overseen byDavid Crowley, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Graminex LLC

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for healthy women experiencing menopause. Specific eligibility details are not provided, but typically participants would need to be experiencing menopausal symptoms and meet certain health criteria.

Inclusion Criteria

I am a woman who hasn't had a period for over 12 months and have moderate menopausal symptoms.

I am willing and able to follow all study requirements.

Provided voluntary, written, informed consent to participate in the study

+5 more

Exclusion Criteria

Allergy, sensitivity, or intolerance to investigational products or placebo ingredients

I have been diagnosed with anxiety, sleep disorder, or major depression.

Current untreated urogenital diagnosis as assessed by the QI

+20 more

Participant Groups

The study tests the effects of two types of pollen extracts (WSPE and LSPE) against a placebo on menopausal symptoms. Women will rate their symptoms using the Menopause Rating Scale over 36 weeks to see if there's any difference between the treatments.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Graminex Water Soluble Pollen Extract (WSPE)Experimental Treatment1 Intervention

Graminex WSPE is a water soluble extract from flower pollen standardized to 6% amino acids.

Group II: Graminex Lipid Soluble Pollen Extract (LSPE)Experimental Treatment1 Intervention

Graminex LSPE is a lipid soluble pollen extract standardized to 7% phytosterols.

Group III: PlaceboPlacebo Group1 Intervention