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New treatment option for Menopausal Women
Official title A Clinical Trial to Investigate the Effect of Pollen Extracts on Menopausal Symptoms in Healthy Women.
ClinicalTrials.gov ID: NCT06889753
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 65, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Presence of menopausal symptoms for at least six months prior to screening including, vasomotor symptoms (hot flushes, sweating) AND at least two of...
- Agrees to maintain current lifestyle as much as possible throughout the study, including diet, exercise, medications, dietary supplements, and sleep
You likely can't join if
- 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
- Current untreated urogenital diagnosis as assessed by the QI
- Unstable metabolic disease or chronic diseases as assessed by the QI
See the full eligibility criteria
Who can join
- 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...
- Agrees to maintain current lifestyle as much as possible throughout the study, including diet, exercise, medications, dietary supplements, and sleep
- Able and willing to complete all study assessments
- Provided voluntary, written, informed consent to participate in the study
- Healthy as determined by medical history with no unstable, diagnosed medical conditions as assessed by the Qualified Investigator (QI)
What rules you out
- 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
- Current untreated urogenital diagnosis as assessed by the QI
- Unstable metabolic disease or chronic diseases as assessed by the QI
- Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
- Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- Current unstable Type I or Type II diabetes
- Significant cardiovascular event in the past six months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
- History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
- Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least three months will be considered by the QI
- Major surgery in the past three months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
- Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years
- after diagnosis are acceptable
- Individuals with unstable autoimmune disease or are immune compromised as assessed by the QI
- Use of medical cannabinoid products
- Chronic use of cannabinoid products (\>2 times/week) as assessed by the QI
- Alcohol intake average of \>2 standard drinks per day as assessed by the QI
- Alcohol or drug abuse within the last 12 months
- Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the how well it works of the investigational product (Sections 7.3.1 and 7.3.2)
- Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
- Individuals who are unable to give informed consent
- Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
- Asthmatic, as assessed by the QI
The study team makes the final eligibility decision.
Where it's taking place
- London, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 45 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.