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

Sexual Functions and Problems in the Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01407445
• Other study ID #: Fcmscsp-tribulus
• Secondary ID: terrestris
• Status: Completed
• Phase: Phase 4
• First received: August 1, 2011
• Last updated: November 9, 2015
• Start date: January 2009
• Est. completion date: May 2011

Study information

• Verified date: November 2015
• Source: Faculdade de Ciências Médicas da Santa Casa de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sexual Functions and Problems in the Adult

Intervention

Drug:
• Placebo
1 tablet/ oral/ 3 times a day for 90 days
• Tribulus terrestris
1 tablet of 250mg/ oral/ 3 times a day for 90 days

Locations

Country	Name	City	State
Brazil	Santa Casa of Sao Paulo Medical School	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Faculdade de Ciências Médicas da Santa Casa de São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual function in post-menopausal women	Based the questionnaires Golombok-Rust Inventory of Sexual Satisfaction (GRISS) and Sexual Quotient - female version (SQF).	90 days	No
Secondary	Female Intervention Efficacy Index (FIEI)		3 months	No