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

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Sonia Maria Rolim Rosa Lima, Faculdade de Ciências Médicas da Santa Casa de São Paulo
ClinicalTrials.gov Identifier:
NCT01407445
First received: August 1, 2011
Last updated: November 9, 2015
Last verified: November 2015
  Purpose
Objective: To study the effects of Tribulus terrestris on sexuality in postmenopausal women.

Condition Intervention Phase
Sexual Functions and Problems in the Adult
Drug: Placebo
Drug: Tribulus terrestris
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Study of the Effects of Tribulus Terrestris on Sexuality in Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by Faculdade de Ciências Médicas da Santa Casa de São Paulo:

Primary Outcome Measures:
  • Sexual function in post-menopausal women [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Based the questionnaires Golombok-Rust Inventory of Sexual Satisfaction (GRISS) and Sexual Quotient - female version (SQF).


Secondary Outcome Measures:
  • Female Intervention Efficacy Index (FIEI) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: January 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
1 tablet of placebo/ oral/ 3 times a day for three months
Drug: Placebo
1 tablet/ oral/ 3 times a day for 90 days
Other Name: lot 168159
Active Comparator: Tribulus terrestris
1 tablet of 250mg/ oral/ 3 times a day for three months
Drug: Tribulus terrestris
1 tablet of 250mg/ oral/ 3 times a day for 90 days
Other Name: lot 168059

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).
  Eligibility

Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01407445

Locations
Brazil
Santa Casa of Sao Paulo Medical School
Sao Paulo, Brazil
Sponsors and Collaborators
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Sonia lima, PhD Faculdade de Ciências Médicas da Santa Casa de São Paulo
  More Information

Responsible Party: 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
ClinicalTrials.gov Identifier: NCT01407445     History of Changes
Other Study ID Numbers: Fcmscsp-tribulus  terrestris 
Study First Received: August 1, 2011
Last Updated: November 9, 2015
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Faculdade de Ciências Médicas da Santa Casa de São Paulo:
Menopause
Sexual dysfunction
Tribulus
Sexuality
Phytotherapeutic Drugs

ClinicalTrials.gov processed this record on August 30, 2016