Effects of Tribulus Terrestris on Sexual Function in Post-menopausal Women

Overview

Objective: To study the effects of Tribulus terrestris on sexuality in postmenopausal women.

Full Title of Study: “Study of the Effects of Tribulus Terrestris on Sexuality in Postmenopausal Women”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 2011

Detailed Description

Sexuality is an integral part of every personality, influence thoughts, feelings, actions, integrations, and therefore the physical and mental health. It is estimated that 43% of women have at least one complaint of sexual problem. Disorders of desire and arousal are among the most common problems found in gynecologic practice. Medicinal plants have been used for therapeutic purposes for thousands of years, and aphrodisiac properties described in several plants. Tribulus terrestris is a plant indigenous to India, recommended in the treatment of infertility, low libido and impotence, and its main active ingredient protodioscin (PTN).

Interventions

  • Drug: Placebo
    • 1 tablet/ oral/ 3 times a day for 90 days
  • Drug: Tribulus terrestris
    • 1 tablet of 250mg/ oral/ 3 times a day for 90 days

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • 1 tablet of placebo/ oral/ 3 times a day for three months
  • Active Comparator: Tribulus terrestris
    • 1 tablet of 250mg/ oral/ 3 times a day for three months

Clinical Trial Outcome Measures

Primary Measures

  • Sexual function in post-menopausal women
    • Time Frame: 90 days
    • Based the questionnaires Golombok-Rust Inventory of Sexual Satisfaction (GRISS) and Sexual Quotient – female version (SQF).

Secondary Measures

  • Female Intervention Efficacy Index (FIEI)
    • Time Frame: 3 months

Participating in This Clinical Trial

Inclusion Criteria

  • Women past menopause, with full autonomy, at least one year of amenorrhea and FSH> 30 mIU / mL.
  • Sexually active
  • Partner is stable and without sexual difficulties
  • Carrier sexual abuse (desire, arousal, orgasm and dyspareunia)

Exclusion Criteria

  • Women on hormone therapy within the preceding 12 months
  • Women without sexual activity
  • With diabetes mellitus
  • Patients with cognitive impairment
  • Patients with hormone-dependent tumor
  • History of psychiatric illness
  • Patients with liver disease
  • Patients with kidney disease
  • Users of drugs with proven to decrease sexual desire
  • Cardivascular disease, renal disease.

Gender Eligibility: Female

Minimum Age: 40 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Faculdade de Ciências Médicas da Santa Casa de São Paulo
  • Collaborator
    • Fundação de Amparo à Pesquisa do Estado de São Paulo
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sonia Maria Rolim Rosa Lima, Study of the Effects of Tribulus Terrestris on Sexuality in Postmenopausal Women – Faculdade de Ciências Médicas da Santa Casa de São Paulo
  • Overall Official(s)
    • Sonia lima, PhD, Principal Investigator, Faculdade de Ciências Médicas da Santa Casa de São Paulo

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