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OpenTrials
Completed

NCT Number: NCT01971099

Effects of Tribulus Terrestris in Women With Hypoactive Sexual Desire Disorder

Hypoactive Sexual Desire Disorder (HSDD) is the most prevalent female sexual dysfunction in society and is strongly linked to the quality of life of women. The androgen hormones decline over age in the premenopausal period, which occurs around 20 years. Tribulus terrestris is a plant native to India, recommended in the treatment of infertility, low libido and impotence. Its main active ingredient is the protodioscin, which has been attributed to an increase in testosterone levels and improved sexual function. The aim of this study is to evaluate the effects of Tribulus Terrestris in premenopausal women with HSDD.

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Key information

Conditions

Hypoactive Sexual Desire Disfunction Behavior Sedentary Behavior

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hospital das Clinicas - Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, 30130100, Brazil

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • regular menstrual cycle
  • with no use of hormonal contraception within the last 3 months
  • without any medication, drugs or alcohol.
  • Healthy patients without systemic or psychiatric disease

Exclusion criteria

  • Patients with amenorrhea and/or pregnant.
  • Patients who underwent bilateral oophorectomy.
  • Patient smoker (10 cigarettes per day).
  • Patients with blood pressure > 160/90 mm Hg.
  • Patient with breast or endometrial carcinoma.
  • Patients with a history of myocardial infarction.
  • Patient with Diabetes.
  • Patient with vaginal bleeding from any source.
  • Patients with hepatic injury.
  • Patients with active thrombophlebitis or thromboembolic disorders recent
  • Patients with interpersonal relationship problems with your relationship or partner
  • Patients with sexual problems from your partner

Treatment and study plan

Tribulus Terrestris

Drug

patients will use 750mg/day of tribulus terrestris

Other names: tribulus

Placebo

Other

patients will take one pill a day (the same shape of the drug)

Primary outcomes

  1. Sexual Desire

    Time frame: 120 days

    we will use the "Quotient Sexual - Version Feminine (QS-F) brazilian questionary to make the evaluation

Secondary outcomes

  1. serum levels of prolactin and thyroid-stimulating hormone (TSH)

    Time frame: 120 days

    blood test

Other outcomes

  1. serum levels of testosterone and sex hormone-binding globulin (SHBG)

    Time frame: 120 days

    blood test

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 29, 2013
Registry last updated
Jan 14, 2016

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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