Effects of Tribulus Terrestris on Sexual Function in Post-menopausal Women
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ClinicalTrials.gov Identifier: NCT01407445 |
Recruitment Status :
Completed
First Posted : August 2, 2011
Last Update Posted : November 10, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sexual Functions and Problems in the Adult | Drug: Placebo Drug: Tribulus terrestris | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Study of the Effects of Tribulus Terrestris on Sexuality in Postmenopausal Women |
Study Start Date : | January 2009 |
Actual Primary Completion Date : | May 2011 |
Actual Study Completion Date : | May 2011 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
1 tablet of placebo/ oral/ 3 times a day for three months
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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
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Drug: Tribulus terrestris
1 tablet of 250mg/ oral/ 3 times a day for 90 days
Other Name: lot 168059 |
- Sexual function in post-menopausal women [ Time Frame: 90 days ]Based the questionnaires Golombok-Rust Inventory of Sexual Satisfaction (GRISS) and Sexual Quotient - female version (SQF).
- Female Intervention Efficacy Index (FIEI) [ Time Frame: 3 months ]

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Ages Eligible for Study: | 40 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01407445
Brazil | |
Santa Casa of Sao Paulo Medical School | |
Sao Paulo, Brazil |
Principal Investigator: | Sonia lima, PhD | Faculdade de Ciências Médicas da Santa Casa de São Paulo |
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 |
Other Study ID Numbers: |
Fcmscsp-tribulus terrestris ( Other Identifier: CEP-008/2009 ) |
First Posted: | August 2, 2011 Key Record Dates |
Last Update Posted: | November 10, 2015 |
Last Verified: | November 2015 |
Menopause Sexual dysfunction Tribulus Sexuality Phytotherapeutic Drugs |