MenopausePhase 4NCT01975649

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

A Phase 4 study testing Tribulus Terrestris in people with Menopause and Sexual Abstinence, run by Federal University of Minas Gerais at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 50 to 65 years, women only
Conditions the study is for: Menopause, Sexual Abstinence
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: Jun 2013to Apr 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 50 to 65 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Show all 10Show fewer

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

Other trials in Brazil

About this study

Read the 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
Being tested: Tribulus Terrestris, Placebo
Keywords: postmenopausal, hypoactive, sexual disorder, androgen
Medical subject headings: Sexual Abstinence, Sedentary Behavior, Sexual Dysfunction, Physiological

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 750 mg/day during 120 days
PlaceboOther
patients will use placebo pills with the same shape of the drug

Study groups in NCT01975649
Study group	Role	What they receive
Tribulus Terrestris	Experimental	patients will use Tribulus terrestris (750 mg/day) during 120 days Receives: Drug: Tribulus Terrestris
Placebo	Placebo comparator	patients will use placebo for 120 days Receives: Other: Placebo

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.

Jun 2013Apr 2015

First posted5 Nov 2013 (estimated)
Study startJun 2013
Primary completionApr 2015
Study completionApr 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for MenopauseStudies 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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01975649
Sponsor's protocol ID: TTC
Other IDs: 245.553C
Status last verified: Apr 2015
First submitted: 29 Oct 2013
Last updated: 3 Apr 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Menopause trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Tribulus Terrestris in Postmenopausal Women With Hypoactive Sexual Desire Disorder
ClinicalTrials.gov ID: NCT01975649
Acronym / sponsor ID: TTC
Conditions: Menopause, Sexual Abstinence
Keywords: postmenopausal, hypoactive, sexual disorder, androgen
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: Jun 2013
Primary completion: Apr 2015 (actual)
Study completion: Apr 2015 (actual)
First posted: 5 Nov 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Tribulus Terrestris	Experimental	Drug: Tribulus Terrestrispatients will use Tribulus terrestris (750 mg/day) during 120 days
Placebo	Placebo comparator	Other: Placebopatients will use placebo for 120 days

Who may qualify

Ages: 50 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (10 listed)

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.

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 750 mg/day during 120 days	Drug	Tribulus Terrestris
Placebopatients will use placebo pills with 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 3 Apr 2015.

Related trials for Menopause

Recruiting
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
Menopause, Perimenopause
Not yet recruiting
The Role of Diet Quality in Sleep Among Women in Postmenopause
Post Menopausal Women
Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
Not yet recruiting
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RecruitingObservational study
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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 Menopause and Sexual Abstinence, 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 10 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 3 Apr 2015. 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?

On the ClinicalTrials.gov record for NCT01975649.

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 3 Apr 2015.