Effects of Tribulus Terrestris in Postmenopausal 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 very common in postmenopausal women due to a reduction in circulating androgen levels. The aim of this study is to evaluate the effects of Tribulus Terrestris in premenopausal women with HSDD.
详细描述
Hypoactive Sexual Desire Disorder ( HSDD ) is the most prevalent female sexual dysfunction in society mainly in postmenopausal women, and is strongly linked to the quality of life of women . The androgen hormones decline over age in the premenopausal period, more sharply after menopause. 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
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •at least one year after last menstrual period
- •with no use of hormonal replacement therapy within the last 3 months
- •without any medication, drugs or alcohol.
- •Healthy patients without systemic or psychiatric disease
排除标准
- •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
Tribulus Terrestris
patients will use Tribulus terrestris (750 mg/day) during 120 days
干预措施: Tribulus Terrestris (Drug)
Placebo
patients will use placebo for 120 days
干预措施: Placebo (Other)
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
MD, PhD
Federal University of Minas Gerais