Effects of Tribulus Terrestris in Postmenopausal Women With Hypoactive Sexual Desire Disorder

This study is currently recruiting participants.
Verified October 2013 by Federal University of Minas Gerais
Sponsor:
Information provided by (Responsible Party):
Selmo Geber, Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT01975649
First received: October 29, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  Purpose

Hypoactive Sexual Desire Disorder ( HSDD ) is very common in postmenopausal women due to a reduction in circulating androgen levels. The aim of this study is to evaluate the effects of Tribulus Terrestris in premenopausal women with HSDD.


Condition Intervention Phase
Menopause
Sexual Abstinence
Drug: Tribulus Terrestris
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Tribulus Terrestris in Postmenopausal Women With Hypoactive Sexual Desire Disorder

Resource links provided by NLM:


Further study details as provided by Federal University of Minas Gerais:

Primary Outcome Measures:
  • Sexual Desire [ Time Frame: 120 days ] [ Designated as safety issue: No ]
    we will use the "Quotient Sexual - Version Feminine (QS-F) brazilian questionary to make the evaluation


Secondary Outcome Measures:
  • serum levels of prolactin and thyroid-stimulating hormone (TSH) [ Time Frame: 120 days ] [ Designated as safety issue: No ]
    Blood test


Other Outcome Measures:
  • serum levels of testosterone and sex hormone-binding globulin (SHBG) [ Time Frame: 120 days ] [ Designated as safety issue: No ]
    Blood test


Estimated Enrollment: 44
Study Start Date: June 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tribulus Terrestris
patients will use Tribulus terrestris (750 mg/day) during 120 days
Drug: Tribulus Terrestris
patients will use 750 mg/day during 120 days
Other Name: tribulus
Placebo Comparator: Placebo
patients will use placebo for 120 days
Other: Placebo
patients will use placebo pills with the same shape of the drug

Detailed Description:

Hypoactive Sexual Desire Disorder ( HSDD ) is the most prevalent female sexual dysfunction in society mainly in postmenopausal women, and is strongly linked to the quality of life of women . The androgen hormones decline over age in the premenopausal period, more sharply after menopause. 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 .

  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • at least one year after last menstrual period
  • with no use of hormonal replacement therapy within the last 3 months
  • without any medication, drugs or alcohol.
  • Healthy patients without systemic or psychiatric disease

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01975649

Contacts
Contact: Selmo Geber, MD PhD 55 31 34099304 sjgeber@terra.com.br
Contact: Karla Zanolla, MD 55 (31) 9923-2737 karlazanolla.souza@gmail.com

Locations
Brazil
Hospital das Clinicas - Universidade Federal de Minas Gerais Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30130100
Contact: Selmo Geber, MD PhD    55 31 34099304    sjgeber@terra.com.br   
Contact: Karla Zanolla, MD    55 (31) 9923-2737    karlazanolla.souza@gmail.com   
Principal Investigator: Selmo Geber, MD PhD         
Sponsors and Collaborators
Federal University of Minas Gerais
Investigators
Principal Investigator: Selmo Geber, MD PhD Federal University of Minas Gerais
  More Information

No publications provided

Responsible Party: Selmo Geber, MD, PhD, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT01975649     History of Changes
Other Study ID Numbers: TTC, 245.553C
Study First Received: October 29, 2013
Last Updated: October 29, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Minas Gerais:
postmenopausal
hypoactive
sexual disorder
androgen

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Hypokinesia
Sexual and Gender Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014