Effects of Tribulus Terrestris in Postmenopausal Women With Hypoactive Sexual Desire Disorder

Study Overview
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Brief Summary
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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.

Detailed Description
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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 .

Official Title
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Effects of Tribulus Terrestris in Postmenopausal Women With Hypoactive Sexual Desire Disorder

Conditions
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Menopause, Sexual Abstinence

Intervention / Treatment
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* Drug: Tribulus Terrestris
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tribulus Terrestris<br>patients will use Tribulus terrestris (750 mg/day) during 120 days | Drug: Tribulus Terrestris<br>* patients will use 750 mg/day during 120 days<br>* Other names: tribulus;|
| Placebo Comparator: Placebo<br>patients will use placebo for 120 days | Other: Placebo<br>* patients will use placebo pills with the same shape of the drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual Desire | we will use the Quotient Sexual - Version Feminine (QS-F) brazilian questionary to make the evaluation | 120 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum levels of prolactin and thyroid-stimulating hormone (TSH) | Blood test | 120 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postmenopausal, hypoactive, sexual disorder, androgen