NCT06889753招募中2 期
A Randomized, Triple-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Effect of Pollen Extracts on Menopausal Symptoms in Healthy Women.
Graminex LLC2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年10月29日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- The difference in change in severity of menopausal symptomsbaseline at Week 36 between Graminex WSPE, Graminex LSPE, and Placebo
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
- •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)
排除标准
- •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 efficacy 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
研究组 & 干预措施
Graminex Water Soluble Pollen Extract (WSPE)
Experimental
Graminex WSPE is a water soluble extract from flower pollen standardized to 6% amino acids.
干预措施: Graminex WSPE (Dietary Supplement)
Graminex Lipid Soluble Pollen Extract (LSPE)
Experimental
Graminex LSPE is a lipid soluble pollen extract standardized to 7% phytosterols.
干预措施: Graminex LSPE (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
The difference in change in severity of menopausal symptomsbaseline at Week 36 between Graminex WSPE, Graminex LSPE, and Placebo
时间窗: Week 0 (baseline) to 36
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.
次要结局
- The difference in change in severity of menopausal symptoms from baseline at Week 6 between Graminex WSPE, Graminex LSPE, and Placebo(Week 0 (baseline) to 6)
- The difference in change in severity of menopausal symptoms 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(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(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(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(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(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(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(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.(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(Week 0 (baseline) to 36)
- The difference in change in sleep disturbance 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(Week 0 (baseline) to 12)
- The difference in change in sleep disturbance 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(Week 0 (baseline) to 36)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
A Study to Find the Best Dose of Fezolinetant to Treat Hot Flashes in Women Going Through MenopauseHot FlashesNCT05034042Astellas Pharma Inc147
已完成
3 期
A Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through MenopauseHot FlashesNCT04003389Astellas Pharma Global Development, Inc.1,831
已完成
2 期
Study the Effect of Danggui Buxue Tang on Menopausal SymptomsMenopauseNCT00421564Chinese University of Hong Kong100
已完成
2 期
Dose Finding Study of Danggui Buxue Tang (Herbal Formula)on the Treatment of Menopausal SymptomsPostmenopausalNCT00420576Chinese University of Hong Kong60
已完成
不适用
Alternative Therapies for Menopause: A Randomized TrialHot FlashesMenopauseNCT00061711National Institute on Aging (NIA)355