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

NCT ID: NCT01975649

Last Updated: 2015-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-04-30

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 .

Conditions

Menopause; Sexual Abstinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tribulus Terrestris

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

Group Type: EXPERIMENTAL

Tribulus Terrestris

Intervention Type: DRUG

patients will use 750 mg/day during 120 days

Placebo

patients will use placebo for 120 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

patients will use placebo pills with the same shape of the drug

Interventions

Tribulus Terrestris

patients will use 750 mg/day during 120 days

Intervention Type: DRUG

Placebo

patients will use placebo pills with the same shape of the drug

Intervention Type: OTHER

Other Intervention Names

tribulus

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Minas Gerais

OTHER

Sponsor Role: lead

Responsible Party

Selmo Geber

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Selmo Geber, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais

Locations

Hospital das Clinicas - Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

245.553C

Identifier Type: OTHER

Identifier Source: secondary_id

TTC

Identifier Type: -

Identifier Source: org_study_id