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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01407445
Recruitment Status : Completed
First Posted : August 2, 2011
Last Update Posted : November 10, 2015
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

Study Description
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Brief Summary:
Objective: To study the effects of Tribulus terrestris on sexuality in postmenopausal women.

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study of the Effects of Tribulus Terrestris on Sexuality in Postmenopausal Women
Study Start Date : January 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011
Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Female Intervention Efficacy Index (FIEI) [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes 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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01407445


Locations
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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
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Principal Investigator: Sonia lima, PhD Faculdade de Ciências Médicas da Santa Casa de São Paulo
More Information
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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    
Other Study ID Numbers: Fcmscsp-tribulus
terrestris ( Other Identifier: CEP-008/2009 )
First Posted: August 2, 2011    Key Record Dates
Last Update Posted: November 10, 2015
Last Verified: November 2015
Keywords provided by Sonia Maria Rolim Rosa Lima, Faculdade de Ciências Médicas da Santa Casa de São Paulo:
Menopause
Sexual dysfunction
Tribulus
Sexuality
Phytotherapeutic Drugs