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.
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: April 2015
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 .
- Drug: Tribulus Terrestris
- patients will use 750 mg/day during 120 days
- Other: Placebo
- patients will use placebo pills with the same shape of the drug
Arms, Groups and Cohorts
- Experimental: Tribulus Terrestris
- patients will use Tribulus terrestris (750 mg/day) during 120 days
- Placebo Comparator: Placebo
- patients will use placebo for 120 days
Clinical Trial Outcome Measures
- Sexual Desire
- Time Frame: 120 days
- we will use the “Quotient Sexual – Version Feminine (QS-F) brazilian questionary to make the evaluation
- serum levels of prolactin and thyroid-stimulating hormone (TSH)
- Time Frame: 120 days
- Blood test
Participating in This Clinical Trial
- 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
- 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
Gender Eligibility: Female
Minimum Age: 50 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Federal University of Minas Gerais
- Provider of Information About this Clinical Study
- Principal Investigator: Selmo Geber, MD, PhD – Federal University of Minas Gerais
- Overall Official(s)
- Selmo Geber, MD PhD, Principal Investigator, Federal University of Minas Gerais
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