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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Graminex Water Soluble Pollen Extract (WSPE) | Experimental | Graminex WSPE is a water soluble extract from flower pollen standardized to 6% amino acids. |
|
| Graminex Lipid Soluble Pollen Extract (LSPE) | Experimental | Graminex LSPE is a lipid soluble pollen extract standardized to 7% phytosterols. |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Graminex WSPE | Dietary Supplement | Graminex Water Soluble Pollen Extract is standardized to 6% amino acids. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The difference in change in severity of menopausal symptomsbaseline at Week 36 between Graminex WSPE, Graminex LSPE, and Placebo | 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. | Week 0 (baseline) to 36 |
| Measure | Description | Time Frame |
|---|---|---|
| The difference in change in severity of menopausal symptoms from baseline at Week 6 between Graminex WSPE, Graminex LSPE, and Placebo | The difference in change in severity of menopausal symptoms as assessed by total MRS score from baseline at Week 6 between Graminex WSPE, Graminex LSPE, and Placebo. | Week 0 (baseline) to 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post-emergent adverse events (AE) | Incidence of post-emergent adverse events (AE) | Week 0 (baseline) to 36 |
| Clinically relevant changes in blood pressure (BP) after supplementation | Clinically relevant changes in blood pressure (BP) after supplementation with WPSE |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erin Lewiss, PhD | Contact | 1-226-242-4551 | 248 | elewis@kgkscience.com |
| Name | Affiliation | Role |
|---|---|---|
| David Crowley, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Science Inc. | Recruiting | London | Ontario | N6B3L1 | Canada |
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| Graminex LSPE | Dietary Supplement | Graminex Lipid Soluble Pollen Extract is standardized to 7% phytosterols. |
|
| Placebo | Dietary Supplement | Placebo |
|
| The difference in change in severity of menopausal symptoms from baseline at Week 12 between Graminex WSPE, Graminex LSPE, and Placebo |
The difference in change in severity of menopausal symptoms as assessed by total MRS score from baseline at Week 12 between Graminex WSPE, Graminex LSPE, and Placebo. |
| Week 0 (baseline) to 12 |
| The difference in change in severity of menopausal symptoms from baseline at Week 24 between Graminex WSPE, Graminex LSPE, and Placebo | The difference in change in severity of menopausal symptoms as assessed by total MRS score from baseline at Week 24 between Graminex WSPE, Graminex LSPE, and Placebo. | Week 0 (baseline) to 24 |
| The difference in change in scores of individual domains of the MRS including Somatic, Psychological, and Urogenital domains between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 6 | The difference in change in scores of individual domains of the MRS including Somatic, Psychological, and Urogenital domains between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 6. | Week 0 (baseline) to 6 |
| The difference in change in scores of individual domains of the MRS including Somatic, Psychological, and Urogenital domains between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 12 | The difference in change in scores of individual domains of the MRS including Somatic, Psychological, and Urogenital domains between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 12. | Week 0 (baseline) to 12 |
| The difference in change in scores of individual domains of the MRS including Somatic, Psychological, and Urogenital domains between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 24 | The difference in change in scores of individual domains of the MRS including Somatic, Psychological, and Urogenital domains between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 24. | Week 0 (baseline) to 24 |
| The difference in change in scores of individual domains of the MRS including Somatic, Psychological, and Urogenital domains between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 36 | The difference in change in scores of individual domains of the MRS including Somatic, Psychological, and Urogenital domains between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 36. | Week 0 (baseline) to 36 |
| The difference in change in scores of individual symptoms included in the MRS between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 6 | The difference in change in scores of individual symptoms included in the MRS between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 6. | Week 0 (baseline) to 6 |
| The difference in change in scores of individual symptoms included in the MRS between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 12 | The difference in change in scores of individual symptoms included in the MRS between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 12. | Week 0 (baseline) to 12 |
| The difference in change in scores of individual symptoms included in the MRS between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 24. | The difference in change in scores of individual symptoms included in the MRS between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 24. | Week 0 (baseline) to 24 |
| The difference in change in scores of individual symptoms included in the MRS between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 36 | The difference in change in scores of individual symptoms included in the MRS between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 36 | Week 0 (baseline) to 36 |
| The difference in change in sleep disturbance between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 6 | The difference in change in sleep disturbance as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance form 8b between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 6 | Week 0 (baseline) to 6 |
| The difference in change in sleep disturbance between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 12 | The difference in change in sleep disturbance as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance form 8b between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 12. | Week 0 (baseline) to 12 |
| The difference in change in sleep disturbance between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 24 | The difference in change in sleep disturbance as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance form 8b between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 24. | Week 0 (baseline) to 24 |
| The difference in change in sleep disturbance between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 36 | The difference in change in sleep disturbance as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance form 8b between Graminex WSPE, Graminex LSPE, and Placebo from baseline at Week 36. | Week 0 (baseline) to 36 |
| Week 0 (baseline) to 36 |
| Clinically relevant changes in blood pressure (BP) after supplementation | Clinically relevant changes in blood pressure (BP) after supplementation with LPSE | Week 0 (baseline) to 36 |
| Clinically relevant changes in heart rate (HR) after supplementation | Clinically relevant changes in heart rate (HR) after supplementation with WSPE | Week 0 (baseline) to 36 |
| Clinically relevant changes in heart rate (HR) after supplementation | Clinically relevant changes in heart rate (HR) after supplementation with LSPE | Week 0 (baseline) to 36 |