Health TrialsbyHealthPanel

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

ConditionMenopausal Women
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age45-65
SponsorGraminex LLC

About 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 accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Graminex Water Soluble Pollen Extract (WSPE)Experimental treatment 1 intervention
Group B: Graminex Lipid Soluble Pollen Extract (LSPE)Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Week 0 (baseline) to 36

Secondary outcomes

1

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.

Time frame
Week 0 (baseline) to 6
2

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.

Time frame
Week 0 (baseline) to 12
3

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.

Time frame
Week 0 (baseline) to 24
4

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.

Time frame
Week 0 (baseline) to 6

Other outcomes

1

Incidence of post-emergent adverse events (AE)

Incidence of post-emergent adverse events (AE)

Time frame
Week 0 (baseline) to 36
2

Clinically relevant changes in blood pressure (BP) after supplementation

Clinically relevant changes in blood pressure (BP) after supplementation with WPSE

Time frame
Week 0 (baseline) to 36
3

Clinically relevant changes in blood pressure (BP) after supplementation

Clinically relevant changes in blood pressure (BP) after supplementation with LPSE

Time frame
Week 0 (baseline) to 36
4

Clinically relevant changes in heart rate (HR) after supplementation

Clinically relevant changes in heart rate (HR) after supplementation with WSPE

Time frame
Week 0 (baseline) to 36

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Graminex LLC

Lead sponsor

KGK Science Inc.

Collaborator

Source ClinicalTrials.gov
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