Effects of Tribulus Terrestris in Women With Hypoactive Sexual Desire Disorder

Phase 4

Completed

• Conditions: Hypoactive Sexual Desire Disfunction
• Interventions: Other: Placebo; Drug: tribulus terrestris

• Registration Number: NCT01971099
• Lead Sponsor: Federal University of Minas Gerais

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-10-23
• Study First Submitted QC: 2013-10-28
• Study First Posted: 2013-10-29
• Primary Completion: 2015-07
• Study Completion: 2015-09
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-13
• Last Update Posted: 2016-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	patients will use placebo for 120 days
Tribulus Terrestris	tribulus terrestris	patients will use Tribulus terrestris (750 mg/day) during 120 days

Primary Outcome Measures

Name	Time	Method
Sexual Desire	120 days	we will use the "Quotient Sexual - Version Feminine (QS-F) brazilian questionary to make the evaluation

Secondary Outcome Measures

Name	Time	Method
serum levels of prolactin and thyroid-stimulating hormone (TSH)	120 days	blood test

Trial Locations

Locations (1)

Hospital das Clinicas - Universidade Federal de Minas Gerais; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil