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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 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: June 8, 2014
Last verified: June 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 8, 2014
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 July 28, 2014