Effects of Tribulus Terrestris in Women With Hypoactive Sexual Desire Disorder

NCT01971099 | Completed Phase 4

• 1 other identifier: TTM1
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoactive Sexual Desire Disfunction

Keywords

sexual function; hypoactive; desire; androgens

Outcome Measures

Primary Outcomes (1)

• Sexual Desire

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

  120 days

Secondary Outcomes (1)

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

  120 days

Other Outcomes (1)

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

  120 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

patients will use placebo for 120 days

Other: Placebo

Tribulus Terrestris

EXPERIMENTAL

patients will use Tribulus terrestris (750 mg/day) during 120 days

Drug: tribulus terrestris

Interventions

tribulus terrestris DRUG

patients will use 750mg/day of tribulus terrestris

Also known as: tribulus

Tribulus Terrestris

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Hospital das Clinicas - Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, 30130100, Brazil

Location

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Tribulus extract

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Selmo Geber, MD PhD

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: October 29, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 14, 2016

Record last verified: 2016-01

Locations

BR (1)