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

Overview

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: April 2015

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 .

Interventions

  • 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

Primary Measures

  • Sexual Desire
    • Time Frame: 120 days
    • we will use the “Quotient Sexual – Version Feminine (QS-F) brazilian questionary to make the evaluation

Secondary Measures

  • serum levels of prolactin and thyroid-stimulating hormone (TSH)
    • Time Frame: 120 days
    • Blood test

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 50 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • 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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