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CompletedNCT01407445Updated Nov 10, 2015

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

A Phase 4 interventional study of Placebo and Tribulus terrestris in Sexual Functions and Problems in the Adult, sponsored by Faculdade de Ciências Médicas da Santa Casa de São Paulo. Completed at 1 site in Brazil. Open to female participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-11-10.

Sponsored by Faculdade de Ciências Médicas da Santa Casa de São Paulo · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
Female
01

Study summary

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

Read the 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).

02

Conditions studied

  • Sexual Functions and Problems in the Adult

Keywords

  • Menopause
  • Sexual dysfunction
  • Tribulus
  • Sexuality
  • Phytotherapeutic Drugs
03

In context

Sexual Dysfunction, Physiological

126 studies on the registry are indexed under Sexual Dysfunction, Physiological; 45 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 88 interventional studies indexed under Sexual Dysfunction, Physiological.

Browse Sexual Dysfunction, Physiological studies →

Lead sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo is the lead sponsor of 41 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    1 tablet of placebo/ oral/ 3 times a day for three months

    Drug: Placebo

  • Active comparator
    Tribulus terrestris

    1 tablet of 250mg/ oral/ 3 times a day for three months

    Drug: Tribulus terrestris

Interventions

  • DrugPlacebo

    1 tablet/ oral/ 3 times a day for 90 days

    Also known as: lot 168159

  • 1 tablet of 250mg/ oral/ 3 times a day for 90 days

    Also known as: lot 168059

06

What researchers measure

Primary outcomes

  1. Sexual function in post-menopausal women

    Based the questionnaires Golombok-Rust Inventory of Sexual Satisfaction (GRISS) and Sexual Quotient - female version (SQF).

    Time frame: 90 days

Secondary outcomes

  1. Female Intervention Efficacy Index (FIEI)

    Time frame: 3 months

07

Study locations

1 site
  • Santa Casa of Sao Paulo Medical School
    São Paulo, São Paulo, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01407445
Lead sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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) — Principal investigator
First posted
Aug 2, 2011
Start date
Jan 2009
Primary completion
May 2011
Completion
May 2011
Last update
Nov 10, 2015

Study contacts

Sonia lima, PhD
principal investigator · Faculdade de Ciências Médicas da Santa Casa de São Paulo

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Tribulus extract

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