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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01975649
Other study ID # TTC
Secondary ID 245.553C
Status Completed
Phase Phase 4
First received October 29, 2013
Last updated April 2, 2015
Start date June 2013
Est. completion date April 2015

Study information

Verified date April 2015
Source Federal University of Minas Gerais
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.


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 .


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Female
Age group 50 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Tribulus Terrestris
patients will use 750 mg/day during 120 days
Other:
Placebo
patients will use placebo pills with the same shape of the drug

Locations

Country Name City State
Brazil Hospital das Clinicas - Universidade Federal de Minas Gerais Belo Horizonte Minas Gerais

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Other serum levels of testosterone and sex hormone-binding globulin (SHBG) Blood test 120 days No
Primary Sexual Desire we will use the "Quotient Sexual - Version Feminine (QS-F) brazilian questionary to make the evaluation 120 days No
Secondary serum levels of prolactin and thyroid-stimulating hormone (TSH) Blood test 120 days No
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