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

Phase 4

Completed

• Conditions: Sexual Functions and Problems in the Adult
• Interventions: Drug: Placebo; Drug: Tribulus terrestris

• Registration Number: NCT01407445
• Lead Sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo

Brief Summary

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

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 Timeline

• Study Start: 2009-01
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Study First Submitted: 2011-08-01
• Study First Submitted QC: 2011-08-01
• Study First Posted: 2011-08-02
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-09
• Last Update Posted: 2015-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	1 tablet of placebo/ oral/ 3 times a day for three months
Tribulus terrestris	Tribulus terrestris	1 tablet of 250mg/ oral/ 3 times a day for three months

Primary Outcome Measures

Name	Time	Method
Sexual function in post-menopausal women	90 days	Based the questionnaires Golombok-Rust Inventory of Sexual Satisfaction (GRISS) and Sexual Quotient - female version (SQF).

Secondary Outcome Measures

Name	Time	Method
Female Intervention Efficacy Index (FIEI)	3 months

Trial Locations

Locations (1)

Santa Casa of Sao Paulo Medical School; 🇧🇷 Sao Paulo, Brazil