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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01975649
Recruitment Status : Completed
First Posted : November 5, 2013
Last Update Posted : April 3, 2015
Sponsor:
Information provided by (Responsible Party):
Selmo Geber, Federal University of Minas Gerais

Tracking Information
First Submitted Date  ICMJE October 29, 2013
First Posted Date  ICMJE November 5, 2013
Last Update Posted Date April 3, 2015
Study Start Date  ICMJE June 2013
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2013)		 Sexual Desire [ Time Frame: 120 days ]
we will use the "Quotient Sexual - Version Feminine (QS-F) brazilian questionary to make the evaluation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2013)		 serum levels of prolactin and thyroid-stimulating hormone (TSH) [ Time Frame: 120 days ]
Blood test
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 29, 2013)		 serum levels of testosterone and sex hormone-binding globulin (SHBG) [ Time Frame: 120 days ]
Blood test
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effects of Tribulus Terrestris in Postmenopausal Women With Hypoactive Sexual Desire Disorder
Official Title  ICMJE Effects of Tribulus Terrestris in Postmenopausal Women With Hypoactive Sexual Desire Disorder
Brief Summary 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.
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 .
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Menopause
  • Sexual Abstinence
Intervention  ICMJE
  • Drug: Tribulus Terrestris
    patients will use 750 mg/day during 120 days
    Other Name: tribulus
  • Other: Placebo
    patients will use placebo pills with the same shape of the drug
Study Arms  ICMJE
  • Experimental: Tribulus Terrestris
    patients will use Tribulus terrestris (750 mg/day) during 120 days
    Intervention: Drug: Tribulus Terrestris
  • Placebo Comparator: Placebo
    patients will use placebo for 120 days
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2013)		 44
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01975649
Other Study ID Numbers  ICMJE TTC
245.553C ( Other Identifier: COEP )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Selmo Geber, Federal University of Minas Gerais
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Federal University of Minas Gerais
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Selmo Geber, MD PhD Federal University of Minas Gerais
PRS Account Federal University of Minas Gerais
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP