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Completed

NCT Number: NCT01407445

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

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

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Key information

Conditions

Sexual Functions and Problems in the Adult Behavior Genital Diseases Sexual Behavior Sexual Dysfunction, Physiological Sexuality Urogenital Diseases

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Santa Casa of Sao Paulo Medical School

São Paulo, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

1 tablet/ oral/ 3 times a day for 90 days

Other names: lot 168159

Tribulus Terrestris

Drug

1 tablet of 250mg/ oral/ 3 times a day for 90 days

Other names: lot 168059

Primary outcomes

  1. 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).

Secondary outcomes

  1. Female Intervention Efficacy Index (FIEI)

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 2, 2011
Registry last updated
Nov 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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