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

November 9, 2015 updated by: Sonia Maria Rolim Rosa Lima, Faculdade de Ciências Médicas da Santa Casa de São Paulo

Study of the Effects of Tribulus Terrestris on Sexuality in Postmenopausal Women

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil
        • Santa Casa of Sao Paulo Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • lot 168059

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
90 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

August 1, 2011

First Submitted That Met QC Criteria

August 1, 2011

First Posted (Estimate)

August 2, 2011

Study Record Updates

Last Update Posted (Estimate)

November 10, 2015

Last Update Submitted That Met QC Criteria

November 9, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Fcmscsp-tribulus
  • terrestris (Other Identifier: CEP-008/2009)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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