Multicentre, Exploratory, Prospective, Open-labelled, Non-controlled Study to Evaluate the Effect of SE5-OH Tablets on Healthy Women With Menopausal Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of SE5-OH tablets on menopausal symptoms.
研究概览
简要总结
Multicentre, exploratory, prospective, open-labelled study to evaluate the efficacy of SE5-OH tablets on menopausal symptoms in healthy women experiencing menopausal symptoms after 12 weeks of administration.
The study will be performed in 10 hospitals (private and public) located in Spain. Recruitment period of 6 months will be defined in order to include up to 300 healthy volunteers from different national hospitals and clinics.
详细描述
Multicentre, exploratory, prospective, open-labelled, non-controlled study to evaluate the efficacy of SE5-OH tablets for menopausal symptoms reduction. SE5-OH tablets are a food supplement containing active S-equol. The daily dose of S-equol is 10 mg in the form of 4 tablets of SE5-OH tablets.
The study will be performed in 10 hospitals (private and public) located in Spain to include up to 300 subjects in 6 months of recruitment period.
Investigators will review the medical history from healthy women with moderate to severe menopausal symptoms who are visiting the participating site, investigators will ensure that each candidate meets all the inclusion criteria and none of exclusion criteria. Suitable participants will be informed during the visit about the nature of the investigational study by receiving first information about the investigational product (food supplement) and invited to participate later when all questions have been addressed. A 14 days' period of reflexion is possible for every participant in accordance with Good Clinical Practice.
The procedures involved will be explained in detail and written consent must be obtained with subject and investigators signature before subject participation. The total duration of each participant in the study will be 16 weeks (12 weeks treatment + 4 weeks follow up). The participation in the study is completely voluntary.
The study consists of 4 visits: 3 visits until the end of treatment (EoT) with 1 follow up/end of study visit (FU/EoS) after treatment completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •45-60 years healthy women who have provided signed ICF.
- •Experiencing menopause symptoms for at least 1 month.
- •Total MRS score ≥9 at inclusion time (baseline).
- •MRS with a score equal or above 9 include women with moderate to severe menopausal symptoms according to the validated analysis of this questionnaire.
排除标准
- •Women currently receiving hormone replacement therapy (HRT) or bio identical hormone replacement therapy (BHRT) or have received HRT/BHRT in the last 3 months.
- •Pregnant, nursing women or women planning to become pregnant*.
- •Subject with a history or presence of clinically severe disease such as hepatic, renal, endocrine, hematologic, immunologic (including chronic inflammatory conditions) and cancer disease.
- •History or presence psychosomatic diseases (drug treatment), epilepsy, rheumatism.
- •Allergies to soy.
- •History of any food behaviour complication (lacking sufficient intake and/or over intake of food)
- •Intestinal malabsorption that could decrease food supplements intestinal absorption.
- •Receiving any drug during the last 3 months for menopause symptoms or any food supplement during the last 1 month that could decrease or hide/mask the effect of the experimental product.
- •Participation to another clinical trial.
- •Any other medical problem identified by the investigator that could alter the ability of the volunteer to participate to the study including non-treated/non controlled thyroid disease, diabetes (among others).
- •A negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or HCG equivalent units) must be performed prior to subject enrolment and must be negative 24 hours prior to initiation of study treatment in case of any suspicious.
结局指标
主要结局
To evaluate the efficacy of SE5-OH tablets on menopausal symptoms.
时间窗: At week 12 from week 0.
To evaluate the efficacy of SE5-OH tablets on menopausal symptoms with the assessment of the menopausal rating scale (MRS) total scores and subscales scores (somatic, psychological, and urogenital) after 12 weeks of treatment from week 0. MRS consists of a list of 11 symptoms, that can get 0 (no symptom) or up to 4 scoring points (severe symptom) depending on the severity of the complaints perceived by the women completing the scale. The total score of the MRS ranges between 0 (asymptomatic) and 44 (highest degree of complaints) and is the sum of the dimension scores. The total score can be categorized into: No little (0-4) / Mild (5-8) / Moderate (9-15) / Severe (≥16). Higher scores mean worse outcome.
次要结局
- To evaluate the changes in sleep quality.(At week 12 from week 0.)
- To evaluate the changes in the vaginal pH.(At week 4, 12 and 16 from week 0.)
- To evaluate the adverse events.(Up to 16 weeks.)
- To evaluate tolerability.(At week 16)
- To evaluate the changes in menopausal symptoms.(At week 4 and 16 from week 0.)
- To evaluate the changes in pain in joint and hand, shoulder, and low back.(At week 12 from week 0)
- To evaluate the changes in work performance associated to menopausal symptoms.(At week 12 from week 0.)
- To evaluate the changes in vasomotor symptoms.(At week 4, 12 and 16 from week 0 based on daily registrations.)
- To evaluate the compliance.(At week 12)
- To evaluate the changes in vulvovaginal symptoms.(At week 4, 12 and 16 from week 0.)
- To evaluate the changes in the vaginal maturation index.(At week 4, 12 and 16 from week 0.)
- To evaluate the changes in body mass index (BMI).(At week 12 from week 0.)
- To evaluate the changes in blood pressure (BP).(At week 16)
- To evaluate the variability of equol producers and equol non-producers among the subjects.(At week 16)