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

Menopause Clinical Trial

Official title:

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

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

• Hypokinesia
• Menopause
• Sexual Abstinence
• Sexual Dysfunctions, Psychological

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