Effects of Tribulus Terrestris on Sexual Function in Post-menopausal Women
This study has been completed.
Sponsor:
Faculdade de Ciências Médicas da Santa Casa de São Paulo
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
ClinicalTrials.gov Identifier:
NCT01407445
First received: August 1, 2011
Last updated: November 9, 2015
Last verified: November 2015
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Purpose
Objective: To study the effects of Tribulus terrestris on sexuality in postmenopausal women.
| Condition | Intervention | Phase |
|---|---|---|
|
Sexual Functions and Problems in the Adult |
Drug: Placebo Drug: Tribulus terrestris |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Study of the Effects of Tribulus Terrestris on Sexuality in Postmenopausal Women |
Resource links provided by NLM:
Further study details as provided by Faculdade de Ciências Médicas da Santa Casa de São Paulo:
Primary Outcome Measures:
- Sexual function in post-menopausal women [ Time Frame: 90 days ] [ Designated as safety issue: No ]Based the questionnaires Golombok-Rust Inventory of Sexual Satisfaction (GRISS) and Sexual Quotient - female version (SQF).
Secondary Outcome Measures:
- Female Intervention Efficacy Index (FIEI) [ 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 (Adult, Senior) |
| 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 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01407445
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
| 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 History of Changes |
| Other Study ID Numbers: | Fcmscsp-tribulus terrestris |
| Study First Received: | August 1, 2011 |
| Last Updated: | November 9, 2015 |
| 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 Phytotherapeutic Drugs |
ClinicalTrials.gov processed this record on September 28, 2016