Effects of Tribulus Terrestris in Postmenopausal Women With Hypoactive Sexual Desire Disorder
2 other identifiers
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 29, 2013
CompletedFirst Posted
Study publicly available on registry
November 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedApril 3, 2015
April 1, 2015
1.8 years
October 29, 2013
April 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sexual Desire
we will use the "Quotient Sexual - Version Feminine (QS-F) brazilian questionary to make the evaluation
120 days
Secondary Outcomes (1)
serum levels of prolactin and thyroid-stimulating hormone (TSH)
120 days
Other Outcomes (1)
serum levels of testosterone and sex hormone-binding globulin (SHBG)
120 days
Study Arms (2)
Tribulus Terrestris
EXPERIMENTALpatients will use Tribulus terrestris (750 mg/day) during 120 days
Placebo
PLACEBO COMPARATORpatients will use placebo for 120 days
Interventions
patients will use 750 mg/day during 120 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital das Clinicas - Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, 30130100, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Selmo Geber, MD PhD
Federal University of Minas Gerais
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
October 29, 2013
First Posted
November 5, 2013
Study Start
June 1, 2013
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
April 3, 2015
Record last verified: 2015-04