Multicenter Prospective Observational Study to Investigate the Effectiveness of a Food Supplement Made of Hop in the Improvement of Menopausal Symptoms
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 443
- 主要终点
- Change in quality of life (QoL) - Measured with Score on the Cervantes Scale
研究概览
简要总结
This observational study will assess the effects of a dietary supplement based on Humulus Lupulus L. to relieve the symptoms of menopause in perimenopausal and postmenopausal women, by doing a follow up of the Cervantes scale and the Anxiety and depression Goldberg Scale in a period of 6 months. Participants will be allocated to dietary supplement being the difference between groups if they are perimenopausal or postmenopausal, and will attend to 3 visits (baseline, 3 months and 6 months).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Perimenopausal according to the Stages of Reproductive Aging Workshop (STRAW) or postmenopausal women between the ages of 40 and
- •Having moderate or severe hot flushes.
- •Accepting and signing the Informed consent.
排除标准
- •Women unable to answer the questionnaires.
- •Women being treated with sulfonamides, methotrexate, triamterene, sulfasalazine, estrogens, phenytoin, anxiolytics, antidepressants, daily multivitamins, hormonal therapy, use of oral contraceptives in the last 3 months, herbal products to reduce vasomotor symptoms in the last months.
- •Women in treatment and control for psychiatric pathology.
- •Women with any comorbidity that could be the cause of a symptomatology coinciding but not bound to peri or post-menopause.
- •Women diagnosed or with Clinical suspicion of breast cancer, endometrium or other hormone-dependent tumors, genital tract bleeding, actives thromboembolic disorders, active gall bladder illness or being lactose intolerant.
- •Women being treated with antithyroid medications and other drugs like letrozole, raloxifene, bazedoxifene, bethanechol, desmopressin and calcitonin or other drugs that at investigators judgement could interfere in the study's result.
- •Use of dietary supplements that include phytoestrogens (drinks or desserts based in soya) in the last month.
- •Women with coronary diseases, strokes or chronic renal diseases, type 2 diabetes, deep vein thrombosis or pulmonary embolism.
结局指标
主要结局
Change in quality of life (QoL) - Measured with Score on the Cervantes Scale
时间窗: Change from baseline, to 3 months and 6 months visit
Score on the Cervantes Scale on quality of life. The scale is composed of 31 questions divided in 4 domains. Each question is punctuated from 0 to 5. And total scale result ranges from 0 to 155, where 0 corresponds to the maximun QoL value and 155 worst value.
Change in quality of life (QoL) - Measured with Score on the Cervantes Scale, domain: Psychic.
时间窗: Change from baseline, to 3 months and 6 months visit
This domain of the Cervantes Scale is composed of 9 items, punctuated from 0 to 5. This domain ranges from 0 to 45, where 0 corresponds to abscence of anxiety and depression problems, and 45 to the maximum level of anxiety and depression problems.
Cervantes personality scale.
时间窗: Measured at Baseline visit
The scale is composed of 20 questions divided in 3 domains. Each question is punctuated from 0 to 5. First domain is introversion, it is comprised of 7 Items. This domain is punctuated from 0 to 10, where 0 represents a more extroverted personality and 10 more introverted. Second domain is emotional instability, it is comprised of 7 Items. This domain is punctuated from 0 to 35, where 0 represents more emotional stability and 35 more emotional instability. Third domain is sincerity, it is comprised of 6 Items. This domain is punctuated from 0 to 30, where 0 represents less sincere and 30 more most sincere.
Change in anxiety and depression - Measured with Score on the Anxiety and Depression Goldberg Scale
时间窗: Change from baseline, to 3 months and 6 months visit
The scale is composed of 18 items. Each item is punctuated from 0 to 5. And total scale result ranges from 0 to 90, where 0 corresponds to depression unlikely and more than 54 to severe depression.
Change in quality of life (QoL) - Measured with Score on the Cervantes Scale, domain: Menopause and Health.
时间窗: Change from baseline, to 3 months and 6 months visit
This domain of the Cervantes Scale is composed of 15 items, punctuated from 0 to 5. This domain ranges from 0 to 75, where 0 corresponds to abscence of physical symptoms, and 75 to the maximum level of physical problems.
Change in quality of life (QoL) - Measured with Score on the Cervantes Scale, domain: Sexuality.
时间窗: Change from baseline, to 3 months and 6 months visit
This domain of the Cervantes Scale is composed of 4 items, punctuated from 0 to 5. This domain ranges from 0 to 20, where 0 corresponds to abscence of sexual problems, and 20 to the maximum level of sexual problems.
Change in quality of life (QoL) - Measured with Score on the Cervantes Scale, domain: Couple relationship.
时间窗: Change from baseline, to 3 months and 6 months visit
This domain of the Cervantes Scale is composed of 3 items, punctuated from 0 to 5. This domain ranges from 0 to 15, where 0 corresponds to abscence of relationship problems, and 15 to the maximum level of relationship problems.
Number of adverse events
时间窗: Through the study, an average of 9 months.
Number of adverse events (recorded in the investigator's CRF) to assess the tolerability/safety of the product
Compliance with treatment
时间窗: 6 months
Recount of product returned at the 3 months visit and at the 6 months visit of study.
Treatment satisfaction
时间窗: Measured at the 6 months visit
Treatment satisfaction is measured in three questions valued from 0 to 10, where 0 is considered worst and 10 better. The three questions are about: 1. Patient satisfaction with the capsules. 2. Patient satisfaction with the results of the treatment. 3. Investigator satisfaction with the results of the treatment.
次要结局
未报告次要终点