Trials / Recruiting
RecruitingNCT06889753
A Clinical Trial to Investigate the Effect of Pollen Extracts on Menopausal Symptoms in Healthy Women.
A Randomized, Triple-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Effect of Pollen Extracts on Menopausal Symptoms in Healthy Women.
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Graminex LLC · Academic / Other
- Sex
- Female
- Age
- 45 Years – 65 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2025-10-29
- Primary completion
- 2026-08-01
- Completion
- 2026-08-01
- First posted
- 2025-03-21
- Last updated
- 2025-11-19
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT06889753. Inclusion in this directory is not an endorsement.