Effects of Tribulus Terrestris on Sexual Function in Post-menopausal Women
Study of the Effects of Tribulus Terrestris on Sexuality in Postmenopausal Women
2 other identifiers
interventional
60
1 country
1
Brief Summary
Objective: To study the effects of Tribulus terrestris on sexuality in postmenopausal women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2009
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 1, 2011
CompletedFirst Posted
Study publicly available on registry
August 2, 2011
CompletedNovember 10, 2015
November 1, 2015
2.3 years
August 1, 2011
November 9, 2015
Conditions
Keywords
Outcome Measures
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).
90 days
Secondary Outcomes (1)
Female Intervention Efficacy Index (FIEI)
3 months
Study Arms (2)
Placebo
PLACEBO COMPARATOR1 tablet of placebo/ oral/ 3 times a day for three months
Tribulus terrestris
ACTIVE COMPARATOR1 tablet of 250mg/ oral/ 3 times a day for three months
Interventions
1 tablet of 250mg/ oral/ 3 times a day for 90 days
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Santa Casa of Sao Paulo Medical School
São Paulo, São Paulo, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sonia lima, PhD
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study of the Effects of Tribulus Terrestris on Sexuality in Postmenopausal Women
Study Record Dates
First Submitted
August 1, 2011
First Posted
August 2, 2011
Study Start
January 1, 2009
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
November 10, 2015
Record last verified: 2015-11