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

NCT01407445 — Phase 4, Completed, 60 participants, Faculdade de Ciências Médicas da Santa Casa de São Paulo

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

RegistryNCT01407445
StatusCompleted
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment60 (Actual)
SponsorFaculdade de Ciências Médicas da Santa Casa de São Paulo (Other); collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
ConditionsSexual Functions and Problems in the Adult
InterventionsPlacebo, Tribulus terrestris (Drug)
Datesstart 2009-01-01, primary completion 2011-05-01, completion 2011-05-01, first posted 2011-08-02, last updated 2015-11-10
Locations1 site in Brazil

Related Papers Related Patents Related Grants Related Experts
All trials for Sexual Functions and Problems in the Adult All trials of Placebo All trials of Tribulus terrestris

-Summary

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

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+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).

+Arms and interventions

ArmTypeInterventionsDescription
PlaceboPlacebo comparatorDrug: Placebo1 tablet of placebo/ oral/ 3 times a day for three months
Tribulus terrestrisActive comparatorDrug: Tribulus terrestris1 tablet of 250mg/ oral/ 3 times a day for three months
  • Placebo (Drug), also known as lot 168159: 1 tablet/ oral/ 3 times a day for 90 days
  • Tribulus terrestris (Drug), also known as lot 168059: 1 tablet of 250mg/ oral/ 3 times a day for 90 days

+Outcome measures

Primary outcomes

  • 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 outcomes

  • Female Intervention Efficacy Index (FIEI) [3 months]

+Eligibility

Sex: Female, ages: 40 Years to 70 Years

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.

+Locations (1)

FacilityCityCountryStatus
Santa Casa of Sao Paulo Medical SchoolSão Paulo, São PauloBrazil

+Investigators

  • Sonia lima, PhD, Principal investigator, Faculdade de Ciências Médicas da Santa Casa de São Paulo