A Randomized, Double Blind, Placebo Controlled study to evaluate the efficacy and safety of NRMN01 in the management of Vasomotor and mood related menopausal symptoms in Peri and Post Menopausal Women
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Reduction in the vasomotor subscale score of the MENQOL-I.
研究概览
简要总结
Menopausal symptoms including hot flushes mood swings sleep disturbances and vaginal dryness can significantly impair the quality of life in affected women. These symptoms may be alleviated to some extent through the administration of local or systemic exogenous estrogen via hormone replacement therapy (HRT). However the long term use of HRT is associated with an increased risk of serious complications including breast cancer cardiovascular events and thromboembolism alongside other potential side effects. Due to these risks there is a growing need for alternative safer options to manage menopausal symptoms effectively.
Although NRMN01 has proven its efficacy in the management of various diseases and disorders further clinical studies are needed to substantiate the clinical efficacy of this in the management of hot flushes and night sweats. Preclinical evidence indicates a non hormonal mechanism of action in reduction of vasomotor symptoms. This clinical trial focuses on evaluating the efficacy and safety of NRMN01 in the management of menopause related symptoms through a non hormonal mechanism. The study is conducted based on the rational that the pre clinical studies highlighted the efficacy of NRMN01 on menopause related symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Peri and post menopausal women aged 40 to 55 years (both inclusive) with intact uterus and self reported hot flushes (at least 10 hot flushes per week for past 5 weeks).
- •Perimenopausal and postmenopausal women who are experiencing bothersome VMS (Vasomotor Symptoms).
- •Perimenopause is defined as amenorrhea for greater than 60 days in the past 12 months post menopause is defined as being without a menstrual cycle due to spontaneous reasons for the preceding 12 months.
- •Participants who score in the range of greater than or equal 12 for Vasomotor symptom domain of MENQOL I.
- •Non alcoholic.
- •No plan to commence new treatments over the study period.
- •Not pregnant, intending pregnancy, or breast feeding during the study period.
- •Understand, willing and able to comply with all study procedures.
- •Women who are not undergoing treatment for vasomotor symptoms.
- •Participants who are agreeing to abstain from all dietary supplements.
- •Participants who can sufficiently comprehend the questionnaires and assessments of the study.
- •No other medical condition known to cause sweating and or flushing.
- •No implanted pacemakers or metal implants.
- •No reliance on electronic devices for regular monitoring (i.e insulin pumps or blood pressure monitors).
- •Results of screening procedures and lab investigations are within normal range or considered not clinically significant by the Principal Investigator.
排除标准
- •Pregnant women or lactating women, women who were actively trying to conceive, participants who had undergone hysterectomy.
- •Suffering from recently diagnosed or unmanaged medical conditions including but not limited to diabetes, hyper or hypotension, cardiovascular disease, gastrointestinal disease requiring regular use of medications, gallbladder disease or gallstones or biliary disease, autoimmune disease, endocrine disease, acute or chronic pain condition, chronic gynaecological disease conditions.
- •Positive serology for HIV, hepatitis B (HBsAg), hepatitis C (anti HCV) or Syphilis at screening.
- •Diagnosis of medical or psychiatric conditions including but not limited to psychiatric disorder (other than mild to moderate depression or anxiety), neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury), cancer or malignancy.
- •Regular medication intake including but not limited to anticonvulsants, benzodiazepines, opioids, corticosteroids, or immunosuppressants.
- •History of using estrogen or progestin containing products in the past 3 months
- •Oral medications causing or influencing hot flushes (Eg. clonidine, SSRI, SNRI etc.)
- •Use of hormonal contraceptives or hormonal medication for any other indication in the last 3 months.
- •Additional mineral or vitamin supplement intake.
- •Participants who are consuming or planning to consume soy or estrogenic foods like soybean oil or other estrogenic diet supplements.
- •Specifically, consumption of soy food greater than or equal 1 portion per week.
- •Women with vasomotor symptoms due to breast cancer treatment or surgical menopause.
- •People who follow vegan diet.
- •Change in medication in the last 3 months or an expectation to change during the study duration.
- •Major lifestyle change planned in the next 2 months.
- •Current or 12 month history of illicit drug abuse.
- •A history of breast cancer in first degree family members
- •Any significant surgeries over the last year.
- •Participation in any other clinical trial a month prior to screening.
结局指标
主要结局
Reduction in the vasomotor subscale score of the MENQOL-I.
时间窗: From Baseline to Day 56 (End of Study).
次要结局
- 1.Reduction in the vasomotor subscale score of the MENQOL-I questionnaire.(2.Reduction in the mean score and subscale scores of MENQOL-I questionnaire.)
研究者
Dr Narayanaswamy V
Vagus Super Specialty Hospital