Randomized, Double-blind, Placebo-controlled Clinical Trial, to Evaluate the Efficacy and Tolerability of the Combination of Soy Isoflavones and Red Clover Extract (FITOGYN) in the Treatment of the Hot Flushes in Menopausal Women.
试验速览
- 阶段
- 4 期
- 入组人数
- 166
- 试验地点
- 20
- 主要终点
- Mean Change in the number of symptoms of hot flashes (including night sweats) at the end of the study (week 22) with respect to baseline (week 6).
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of FITOGYN vs. placebo on the vasomotor symptomatology associated with menopause, to evaluate the symptoms of anxiety, the metabolic parameters in menopause and to evaluate the quality of life associated to the vasomotor symptoms of menopause.
详细描述
One of the most significant problems for assessing treatment of hot flushes is the placebo effect. A Phase IV study with an innovative design, intended to additionally assess such effect, is reported. The efficacy of Fitogyn for the treatment of hot flushes in menopausal women with moderate symptoms will be assessed. Secondary objectives will include evaluation of the impact of Fitogyn as compared to placebo on overall menopause symptoms (fatigue, joint pain, vaginal dryness, and sleep disturbances), anxiety, quality of life, and cardiovascular parameters. Equol levels in blood will also be measured to study its potential impact on the outcome of treatment with these isoflavones.
The duration of the study participants will be 22 weeks. 7 visits are planned during the study:
After the screening visit (visit 1), women selected will report on the daily occurrence of hot flushes for 2 weeks without treatment. If they experience the required number of hot flushes (35-70 hot flushes in the prior week and 9 or more of them with at least moderate intensity), a 4-week placebo run-in period will start (visit 2). After this time (Visit 3), women with a decrease lower than 25% in the number of hot flushes and a treatment adherence of at least 80% will be randomised to receive treatment (Fitogyn vs placebo) for 16 weeks.
During visit 3, baseline assessments of primary and secondary variables will be carried out. Additionally, blood and urine samples will be obtained to conduct hematological and biochemical tests, and assess thyroid function and lipid profile. In addition, patients will complete the following scales: "Menopausal Rating Scale (MRS)", the scales of anxiety (HADS) and quality of life (Scale of Cervantes).
Visits 4, 5 and 6: To assess every 4 weeks the treatment adherence, to do a safety evaluation and daily collection of hot flashes.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between 45 and 60 years of age.
- •Women in, the immediate or established postmenopausal phase, defined as women with: a) 12 months or more spontaneous amenorrhea or b) 6 months or more spontaneous amenorrhea with levels of follicular stimulating hormone (FSH) above 40 mIU / ml.
- •Women with between 35 and 70 episodes of hot flashes (9 or more hot flashes should be of at least moderate intensity) in the week prior to the pre-inclusion period with placebo
- •Women who have given written informed consent.
排除标准
- •Women with surgical menopause.
- •Treatment with HRT within 6 months of the screening visit.
- •Patients who needs oncological or immunosuppressive treatment during the expected follow-up period.
- •Patient with difficult follow-up or with psycho-neurological problems that hinder proper assessment (alcoholism, depression not caused by menopause, etc.)
- •Patients who, at the discretion of the investigator, can not be evaluated according to criteria established in this protocol
- •Patients following a vegetarian diet
- •Patients with any relevant gastrointestinal disease
- •Patients with a prior diagnosis of hypothyroidism or other clinically relevant thyroid disorder.
- •Patients treated and / or diagnosed or with suspicion of cancer.
- •Patients with diabetes mellitus who require insulin therapy.
- •Patients with current diagnosis of an affective disorder (e.g. depression), anxiety disorder, or psychotic disorder.
- •Patients with an organic mental disorder
- •Patients with neuropathic pain or any other form of pain that receive or need treatment with antidepressives or anticonvulsivants.
- •Patients receiving or requiring treatment with antidepressives or anticonvulsivants for other motives (for example, prevention of the migraine).
- •Patients consuming more than 2 alcoholic drinks (16-20 gr.) per day
- •Patients who have been treated with antibiotics within 3 months of the screening visit.
- •Patients receiving or requiring treatment with clonidine or vitamin E.
- •Patients who are treated with NSAIDs
- •Patients allergic to any of the components of FITOGYN
- •Patients who took less than 80% of the capsules in the pre-inclusion period with placebo.
- •Patients whose weekly number of hot flushes is reduced by 25% or more during the pre-inclusion period as compared to the week prior to the initiation of that period.
研究组 & 干预措施
Fitogyn
4 weeks with placebo followed by 16 weeks with Fitogyn, both taking two capsules per day during the breakfast.
干预措施: Soy isoflavones (Glycine max L) and red clover extract (Trifolium pretense L) (Drug)
Fitogyn
4 weeks with placebo followed by 16 weeks with Fitogyn, both taking two capsules per day during the breakfast.
干预措施: Placebo (Drug)
Placebo
20 weeks with placebo, taking two capsules per day during the breakfast.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change in the number of symptoms of hot flashes (including night sweats) at the end of the study (week 22) with respect to baseline (week 6).
时间窗: 16 weeks
This change will be expressed in absolute value and proportion of reduction with regard to the number basal of symptoms reported in the last week of the period of pre inclusion. The average or average of the reduction of hot flushes in every week of treatment and at the end of the treatment will be compared. This information will be obtained for every group and recorded by the women using a "hot flushes diary". Additionally, the average change will be evaluated using the hot flash score (frequency combined with intensity) following the same methodology.
次要结局
- Intensity of Hot Flashes(16 weeks)
- Impact of the treatment with FITOGYN on the overall symptoms of menopause: fatigue, joint pain, vaginal dryness and sleep disturbances among others.(16 weeks)
- Effect of the treatment with FITOGYN in the level of anxiety of postmenopausal women.(16 weeks)
- Effect of the treatment with FITOGYN in the quality of life of postmenopausal women.(16 weeks)
- Evaluate the change in the subject's lipidic profile.(16 weeks)
- Evaluation of the safety and tolerability.(16 weeks)