Effects of Lepidium Meyenii Walp (Peruvian Maca) on Sexual Function in Postmenopausal

Universidade do Vale do Sapucai1 个研究点分布在 1 个国家目标入组 144 人开始时间: 2015年10月最近更新: 2016年6月21日

适应症

干预措施

试验速览

阶段: 1 期
发起方
入组人数: 144
试验地点: 1
主要终点: FSFI Questionnaire to evaluate the sexual function

研究概览研究设计入排标准研究组 & 干预措施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

Objective: To study the effects of Lepidium Meyenii in sexual function of postmenopausal women.

Method: It will be held a clinical, prospective, randomized, double-blind, placebo-controlled study with 144 postmenopausal women with sexual dysfunction, treated at Menopause Clinic at the Faculty of Medical Sciences of Santa Casa de São Paulo and in the Vale do Sapucai University. All women sign the Consent Form Term. The study will be conducted in accordance with the protocol and principles of the Declaration Helsinki (Version 1996), according to International Conference on Harmonization and Tripartite Guidelines for good clinical practice and regulatory requirements. The protocol was approved by the Ethics Committee of the Faculty of Medical Sciences of Santa Casa de São Paulo.

Hypothesis: It is expected to be an improvement of sexual function in postmenopausal women.

详细描述

It will be a prospective, randomized, double-blind, placebo-controlled study with 144 postmenopausal women with sexual dysfunction, met in Menopause Clinic at the Faculty of Medical Sciences of Santa Casa de São Paulo and in the Vale do Sapucai University. All women signed the Informed Consent. The study will be conducted in accordance with the protocol and principles set out in Declaration of Helsinki (1996 version), according to International Conference on Harmonization and Tripartite Guidelines for good practice clinics and applicable regulatory requirements.

The protocol was submitted and approved by the Ethics Committee, Faculty of Medical Sciences Committee Santa Casa de São Paulo. The diagnosis of sexual dysfunction will be done by a sexologist physician experienced and trained in the diagnosis of female sexual disorders through a structured clinical interview, a list of sexual symptoms. It will be oriented to avoid further consumption of diet or another type of herbal medicine during the study. After the interview, signing the Informed Consent and they will be informed about the randomization. Interview with sexological questionnaires will be applied used in Sexology Clinic, Faculty of Medical Sciences of Santa Casa de São Paulo and Vale do Sapucai University, with the purpose of obtaining data sociodemographic. The Female Sexual function Index (FSFI) and the Female Intervention Efficacy Index questionnaire (FIEI). When necessary, the Beck Depression Inventory II (Cunha 2001) will be used to ward off depression, which will be applied by enabled professional. The application will be individually and by the same researcher. The results will be analyzed and interpreted in the light of the theoretical framework of socio-historical psychology, this theory of knowledge, is associated with the understanding of the culture of the structure, social organization and the rescue human subjectivity.

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, Care Provider, Investigator)

入排标准

年龄范围: 45 Years 至 65 Years（Adult, Older Adult）
性别: Female
接受健康志愿者: 是

入选标准

•The postmenopausal women with full autonomy, with one year or more of amenorrhea and follicle stimulating hormone (FSH) > 30 milli-International unit/mL
•Women who are not regularly practicing sexual activity will be included because the desire domain is subject to the same evaluation in this situation
•Estrogen and progesterone were permitted if the dose had been stable for six months prior to screening

排除标准

•Cardiac, renal and hepatic diseases
•Diabetes mellitus
•Cognitive disorders
•Hormone-dependent tumor
•History of psychiatric illness current and/or past, regular use of two or more doses of alcohol by day (dose = 12 grams of pure alcohol, which corresponds to 330 mL of beer, 100 mL wine, 30 mL of distilled World Health Organization standard dose) leading to impairment or clinically significant distress (DSM-5)
•Consumption of Maca supplements or any other nutritional supplement known to cause changes in sexual function
•Use of any drug that, in the opinion of the investigator, may affect sexual function or any of the following medications: anti-epileptics, cytochrome P450 isoform 3A4 (CYP3A4) inducers
•Dopamine agonists and other parkinsonian drugs
•Metoclopramide
•Androgens and antiandrogens, the anti-oestrogens
•Fluoxetine or any hormonal implant long-acting in 30 days before the exam
•Analogues of gonadotropin-releasing hormone and other hormones and inhibitors
•Benzodiazepines prescribed for insomnia
•Sedatives and hypnotics
•Antidepressants
•Antipsychotics, mood stabilizers, narcotics (except when used to relieve short-term pain),
•Lubricants/moisturizers that contain substances that promote heating and/or vaginal stimulators