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

Primary Purpose

Menopause, Sexual Abstinence

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Tribulus Terrestris
Placebo
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menopause focused on measuring postmenopausal, hypoactive, sexual disorder, androgen

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital das Clinicas - Universidade Federal de Minas Gerais

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tribulus Terrestris

Placebo

Arm Description

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

patients will use placebo for 120 days

Outcomes

Primary Outcome Measures

Sexual Desire
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)
Blood test

Full Information

First Posted
October 29, 2013
Last Updated
April 2, 2015
Sponsor
Federal University of Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT01975649
Brief Title
Effects of Tribulus Terrestris in Postmenopausal Women With Hypoactive Sexual Desire Disorder
Official Title
Effects of Tribulus Terrestris in Postmenopausal Women With Hypoactive Sexual Desire Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause, Sexual Abstinence
Keywords
postmenopausal, hypoactive, sexual disorder, androgen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tribulus Terrestris
Arm Type
Experimental
Arm Description
patients will use Tribulus terrestris (750 mg/day) during 120 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
patients will use placebo for 120 days
Intervention Type
Drug
Intervention Name(s)
Tribulus Terrestris
Other Intervention Name(s)
tribulus
Intervention Description
patients will use 750 mg/day during 120 days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
patients will use placebo pills with the same shape of the drug
Primary Outcome Measure Information:
Title
Sexual Desire
Description
we will use the "Quotient Sexual - Version Feminine (QS-F) brazilian questionary to make the evaluation
Time Frame
120 days
Secondary Outcome Measure Information:
Title
serum levels of prolactin and thyroid-stimulating hormone (TSH)
Description
Blood test
Time Frame
120 days
Other Pre-specified Outcome Measures:
Title
serum levels of testosterone and sex hormone-binding globulin (SHBG)
Description
Blood test
Time Frame
120 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selmo Geber, MD PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clinicas - Universidade Federal de Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130100
Country
Brazil

12. IPD Sharing Statement

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

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