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

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Menopause Sexual Abstinence Drug: Tribulus Terrestris Other: Placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Tribulus Terrestris in Postmenopausal Women With Hypoactive Sexual Desire Disorder
Study Start Date : June 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Sexual Desire [ Time Frame: 120 days ]
    we will use the "Quotient Sexual - Version Feminine (QS-F) brazilian questionary to make the evaluation


Secondary Outcome Measures :
  1. serum levels of prolactin and thyroid-stimulating hormone (TSH) [ Time Frame: 120 days ]
    Blood test


Other Outcome Measures:
  1. serum levels of testosterone and sex hormone-binding globulin (SHBG) [ Time Frame: 120 days ]
    Blood test


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01975649


Locations
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Brazil
Hospital das Clinicas - Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 30130100
Sponsors and Collaborators
Federal University of Minas Gerais
Investigators
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Principal Investigator: Selmo Geber, MD PhD Federal University of Minas Gerais
More Information
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Responsible Party: Selmo Geber, MD, PhD, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT01975649    
Other Study ID Numbers: TTC
245.553C ( Other Identifier: COEP )
First Posted: November 5, 2013    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015
Keywords provided by Selmo Geber, Federal University of Minas Gerais:
postmenopausal
hypoactive
sexual disorder
androgen
Additional relevant MeSH terms:
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Hypokinesia
Sexual Dysfunctions, Psychological
Dyskinesias
 Neurologic Manifestations
Nervous System Diseases
Mental Disorders