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

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
Faculdade de Ciências Médicas da Santa Casa de São Paulo
ClinicalTrials.gov Identifier:
NCT01407445
First received: August 1, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
  Purpose

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


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

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

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

Primary Outcome Measures:
  • Sexual Satisfaction Inventory- Female Version [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effects of Tribulus terrestris on sexuality [ 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
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
  • Women without sexual activity
  • With diabetes mellitus
  • Patients with cognitive impairment
  • Patients with hormone-dependent tumor
  • History of current psychiatric illness and / or in the past
  • Patients with liver disease, except for prior cholecystectomy.
  • Patients with kidney disease
  • Users of drugs with proven decrease in sexual desire.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Sostenes Postigo, Fcmscsp
ClinicalTrials.gov Identifier: NCT01407445     History of Changes
Other Study ID Numbers: Fcmscsp-tribulus, terrestris
Study First Received: August 1, 2011
Last Updated: August 1, 2011
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

ClinicalTrials.gov processed this record on November 27, 2014