Clinical Efficacy of an Ammonium Succinate-based Dietary Supplement in Women With Menopausal Symptoms: a Pooled Analysis of the Data From Two Randomized, Multicenter, Double-blinded Placebo-controlled Clinical Trials.

I.M. Sechenov First Moscow State Medical University1 个研究点分布在 1 个国家目标入组 227 人开始时间: 2017年2月11日最近更新: 2017年10月20日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: I.M. Sechenov First Moscow State Medical University
入组人数: 227
试验地点: 1
主要终点: "Loss of interest in most things" symptom (Greene Climacteric Scale)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a pooled statistical analysis of the data from 2 studies concerning efficacy of ammonium-succinate based dietary supplement. In both studies group 1 took the ammonium-succinate based dietary supplement and the group 2 took placebo.

详细描述

Both studies were conducted previously and were randomized, double-blind and placebo-controlled. They followed very similar protocols, were of nearly identical design, had common inclusion and exclusion criteria. Both studies achieved statistical significance for ammonium succinate-based dietary supplement on most of pre-specified endpoints of Greene Climacteric Scale symptoms severity reduction at week 12. Nevertheless, some minor variation in the patient population, both within the studies (e.g., between different centres, as well as seasonal variability) and between the studies can be expected.

Naturally occuring estrogen deficiency over the course of the menopausal transition and postmenopause causes hot flushes and other psychosomatic and vasomotor symptoms. Menopausal hormone therapy is a method of choice, however in many cases it is contraindicated or unacceptable for other reasons. Many alternatives exist, generally acting via estrogen receptors (ER). The dietary supplement tested in the aforementioned studies contains ammonium succinate, which does not bind to ER, instead acting by supporting the Krebs cycle. It does not have phytoestrogenic ingredients.

研究设计

研究类型: Observational
观察模型: Other
时间视角: Retrospective

入排标准

年龄范围: 42 Years 至 60 Years（Adult）
性别: Female
接受健康志愿者: 否

入选标准

•vasomotor and psychosomatic complaints
•ability to comply to study protocol
•signed informed consent

排除标准

•cancer (current or prior, based on medical history)
•conditions requiring planned hospitalization in the next 6 months;
•endocrine diseases with abnormal hormonal secretion (hypercorticism, hyperprplactinemia, hypersomatotropism, thyroid disorders et c.);
•any surgeries within 1 year of the screening;
•hormone therapy within 6 months of the screening;
•psychiatric diseases;
•diabetes mellitus;
•taking other supplements or medications that may affect the climacteric syndrome