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

Phase 4

Completed

• Conditions: Menopause; Sexual Abstinence
• Interventions: Drug: Tribulus Terrestris; Other: Placebo

• Registration Number: NCT01975649
• Lead Sponsor: Federal University of Minas Gerais

Brief Summary

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

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 .

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-10-29
• Study First Submitted QC: 2013-10-29
• Study First Posted: 2013-11-05
• Status Verified: 2015-04
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-02
• Last Update Posted: 2015-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tribulus Terrestris	Tribulus Terrestris	patients will use Tribulus terrestris (750 mg/day) during 120 days
Placebo	Placebo	patients will use placebo for 120 days

Primary Outcome Measures

Name	Time	Method
Sexual Desire	120 days	we will use the "Quotient Sexual - Version Feminine (QS-F) brazilian questionary to make the evaluation

Secondary Outcome Measures

Name	Time	Method
serum levels of prolactin and thyroid-stimulating hormone (TSH)	120 days	Blood test

Trial Locations

Locations (1)

Hospital das Clinicas - Universidade Federal de Minas Gerais; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil