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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.