Effects of Tribulus Terrestris in Women With Hypoactive Sexual Desire Disorder

Overview

Hypoactive Sexual Desire Disorder (HSDD) is the most prevalent female sexual dysfunction in society and is strongly linked to the quality of life of women. The androgen hormones decline over age in the premenopausal period, which occurs around 20 years. 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 Type

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

Interventions

  • Drug: tribulus terrestris
    • patients will use 750mg/day of tribulus terrestris
  • Other: Placebo
    • patients will take one pill a day (the same shape of the drug)

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • patients will use placebo for 120 days
  • Experimental: Tribulus Terrestris
    • patients will use Tribulus terrestris (750 mg/day) during 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

  • regular menstrual cycle
  • with no use of hormonal contraception within the last 3 months
  • without any medication, drugs or alcohol.
  • Healthy patients without systemic or psychiatric disease

Exclusion Criteria

  • Patients with amenorrhea and/or pregnant.
  • Patients who underwent bilateral oophorectomy.
  • 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: 18 Years

Maximum Age: 45 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, Professor – Federal University of Minas Gerais
  • Overall Official(s)
    • Selmo Geber, MD PhD, Principal Investigator, Federal University of Minas Gerais

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