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

Sponsor

Federal University of Minas Gerais (Other)

Overall Status

Completed

CT.gov ID

NCT01975649

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

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

Study Type:

Interventional

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 :

Jun 1, 2013

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

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 Names: 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

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 Names:

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

Primary Outcome Measures

Sexual Desire [120 days]
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) [120 days]
Blood test

Other Outcome Measures

serum levels of testosterone and sex hormone-binding globulin (SHBG) [120 days]
Blood test

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts 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