Hypoactive Sexual Desire DisfunctionPhase 4NCT01971099
Effects of Tribulus Terrestris in Women With Hypoactive Sexual Desire Disorder
A Phase 4 study testing tribulus terrestris in people with Hypoactive Sexual Desire Disfunction, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
Hypoactive Sexual Desire Disorder (HSDD) is the most prevalent female sexual dysfunction in society and is strongly linked to the quality of life of women. The androgen hormones decline over age in the premenopausal period, which occurs around 20 years. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hypoactive Sexual Desire Disfunction
- What is being tested?
- tribulus terrestris
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- May 2013to Sep 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- regular menstrual cycle
- with no use of hormonal contraception within the last 3 months
- without any medication, drugs or alcohol.
- Healthy patients without systemic or psychiatric disease
Who cannot join
- Patients with amenorrhea and/or pregnant.
- Patients who underwent bilateral oophorectomy.
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clinicas - Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, 30130100
About this study
Hypoactive Sexual Desire Disorder (HSDD) is the most prevalent female sexual dysfunction in society and is strongly linked to the quality of life of women. The androgen hormones decline over age in the premenopausal period, which occurs around 20 years. 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
- Hypoactive Sexual Desire Disfunction
- Being tested
- tribulus terrestris, Placebo
- Keywords
- sexual function, hypoactive, desire, androgens
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tribulus terrestrisDrug
Also called tribulus
patients will use 750mg/day of tribulus terrestris
PlaceboOther
patients will take one pill a day (the same shape of the drug)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | patients will use placebo for 120 days Receives: Other: Placebo |
| Tribulus Terrestris | Experimental | patients will use Tribulus terrestris (750 mg/day) during 120 days Receives: Drug: tribulus terrestris |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Desire
we will use the "Quotient Sexual - Version Feminine (QS-F) brazilian questionary to make the evaluation
Measured: 120 days
Secondary outcomes (1)
serum levels of prolactin and thyroid-stimulating hormone (TSH)
blood test
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoactive Sexual Desire DisfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selmo Geber, Federal University of Minas Gerais
- Investigators
- Selmo Geber, MD PhD, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971099
- Sponsor's protocol ID
- TTM1
- Status last verified
- Jan 2016
- First submitted
- 23 Oct 2013
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tribulus Terrestris in Women With Hypoactive Sexual Desire Disorder
- ClinicalTrials.gov ID
- NCT01971099
- Acronym / sponsor ID
- TTM1
- Conditions
- Hypoactive Sexual Desire Disfunction
- Keywords
- sexual function, hypoactive, desire, androgens
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 29 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypoactive Sexual Desire Disorder (HSDD) is the most prevalent female sexual dysfunction in society and is strongly linked to the quality of life of women. The androgen hormones decline over age in the premenopausal period, which occurs around 20 years. 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebopatients will use placebo for 120 days |
| Tribulus Terrestris | Experimental | Drug: tribulus terrestrispatients will use Tribulus terrestris (750 mg/day) during 120 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- regular menstrual cycle
- with no use of hormonal contraception within the last 3 months
- without any medication, drugs or alcohol.
- Healthy patients without systemic or psychiatric disease
Key exclusion criteria (12 listed)
- Patients with amenorrhea and/or pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tribulus terrestrisAlso: tribuluspatients will use 750mg/day of tribulus terrestris | Drug | Tribulus Terrestris |
| Placebopatients will take one pill a day (the same shape of the drug) | Other | Placebo |
Primary outcome
Sexual Desire
Time frame: 120 days
we will use the "Quotient Sexual - Version Feminine (QS-F) brazilian questionary to make the evaluation
1 secondary outcome
serum levels of prolactin and thyroid-stimulating hormone (TSH)
Time frame: 120 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selmo Geber, MD PhD principal investigator
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tribulus terrestris in people with Hypoactive Sexual Desire Disfunction, run by Federal University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Desire (time frame: 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2016.