Back to resultsEffects of Tribulus Terrestris in Women With Hypoactive Sexual Desire Disorder
Primary Purpose
Hypoactive Sexual Desire Disfunction
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
tribulus terrestris
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypoactive Sexual Desire Disfunction focused on measuring sexual function, hypoactive, desire, androgens
Eligibility Criteria
Inclusion Criteria:
- regular menstrual cycle
- with no use of hormonal contraception within the last 3 months
- without any medication, drugs or alcohol.
- Healthy patients without systemic or psychiatric disease
Exclusion Criteria:
Patients with amenorrhea and/or pregnant.
- Patients who underwent bilateral oophorectomy.
- 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
Placebo Comparator
Experimental
Arm Label
Placebo
Tribulus Terrestris
Arm Description
patients will use placebo for 120 days
patients will use Tribulus terrestris (750 mg/day) during 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
NCT ID
NCT01971099
First Posted
October 23, 2013
Last Updated
January 13, 2016
Sponsor
Federal University of Minas Gerais
1. Study Identification
Unique Protocol Identification Number
NCT01971099
Brief Title
Effects of Tribulus Terrestris in Women With Hypoactive Sexual Desire Disorder
Official Title
Effects of Tribulus Terrestris in Women With Hypoactive Sexual Desire Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
September 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 the most prevalent female sexual dysfunction in society and is strongly linked to the quality of life of women. The androgen hormones decline over age in the premenopausal period, which occurs around 20 years. 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
Hypoactive Sexual Desire Disfunction
Keywords
sexual function, hypoactive, desire, androgens
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
Placebo
Arm Type
Placebo Comparator
Arm Description
patients will use placebo for 120 days
Arm Title
Tribulus Terrestris
Arm Type
Experimental
Arm Description
patients will use Tribulus terrestris (750 mg/day) during 120 days
Intervention Type
Drug
Intervention Name(s)
tribulus terrestris
Other Intervention Name(s)
tribulus
Intervention Description
patients will use 750mg/day of tribulus terrestris
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
patients will take one pill a day (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
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
regular menstrual cycle
with no use of hormonal contraception within the last 3 months
without any medication, drugs or alcohol.
Healthy patients without systemic or psychiatric disease
Exclusion Criteria:
Patients with amenorrhea and/or pregnant.
Patients who underwent bilateral oophorectomy.
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 Women With Hypoactive Sexual Desire Disorder
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