Effects of Tribulus Terrestris in Women With Hypoactive Sexual Desire Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Sexual Desire
研究概览
简要总结
Hypoactive Sexual Desire Disorder (HSDD) is the most prevalent female sexual dysfunction in society and is strongly linked to the quality of life of women. The androgen hormones decline over age in the premenopausal period, which occurs around 20 years. Tribulus terrestris is a plant native to India, recommended in the treatment of infertility, low libido and impotence. Its main active ingredient is the protodioscin, which has been attributed to an increase in testosterone levels and improved sexual function. The aim of this study is to evaluate the effects of Tribulus Terrestris in premenopausal women with HSDD.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •regular menstrual cycle
- •with no use of hormonal contraception within the last 3 months
- •without any medication, drugs or alcohol.
- •Healthy patients without systemic or psychiatric disease
排除标准
- •Patients with amenorrhea and/or pregnant.
- •Patients who underwent bilateral oophorectomy.
- •Patient smoker (10 cigarettes per day).
- •Patients with blood pressure > 160/90 mm Hg.
- •Patient with breast or endometrial carcinoma.
- •Patients with a history of myocardial infarction.
- •Patient with Diabetes.
- •Patient with vaginal bleeding from any source.
- •Patients with hepatic injury.
- •Patients with active thrombophlebitis or thromboembolic disorders recent
- •Patients with interpersonal relationship problems with your relationship or partner
- •Patients with sexual problems from your partner
研究组 & 干预措施
Placebo
patients will use placebo for 120 days
干预措施: Placebo (Other)
Tribulus Terrestris
patients will use Tribulus terrestris (750 mg/day) during 120 days
干预措施: tribulus terrestris (Drug)
结局指标
主要结局
Sexual Desire
时间窗: 120 days
we will use the "Quotient Sexual - Version Feminine (QS-F) brazilian questionary to make the evaluation
次要结局
- serum levels of prolactin and thyroid-stimulating hormone (TSH)(120 days)
研究者
Selmo Geber
Professor
Federal University of Minas Gerais