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

Study Overview
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Brief Summary
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Objective: To study the effects of Tribulus terrestris on sexuality in postmenopausal women.

Detailed Description
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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).

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

Conditions
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Sexual Functions and Problems in the Adult

Intervention / Treatment
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* Drug: Placebo
* Drug: Tribulus terrestris


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>1 tablet of placebo/ oral/ 3 times a day for three months | Drug: Placebo<br>* 1 tablet/ oral/ 3 times a day for 90 days<br>* Other names: lot 168159;|
| Active Comparator: Tribulus terrestris<br>1 tablet of 250mg/ oral/ 3 times a day for three months | Drug: Tribulus terrestris<br>* 1 tablet of 250mg/ oral/ 3 times a day for 90 days<br>* Other names: lot 168059;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Female Intervention Efficacy Index (FIEI) |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menopause, Sexual dysfunction, Tribulus, Sexuality, Phytotherapeutic Drugs