Sexual Functions and Problems in the AdultPhase 4NCT01407445
Effects of Tribulus Terrestris on Sexual Function in Post-menopausal Women
A Phase 4 study testing Tribulus terrestris in people with Sexual Functions and Problems in the Adult, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
Trial summary
Objective: To study the effects of Tribulus terrestris on sexuality in postmenopausal women. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Sexual Functions and Problems in the Adult
- 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
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2009to May 2011
- 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 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women past menopause, with full autonomy, at least one year of amenorrhea and FSH> 30 mIU / mL.
- Sexually active
- Partner is stable and without sexual difficulties
- Carrier sexual abuse (desire, arousal, orgasm and dyspareunia)
Who cannot join
- Women on hormone therapy within the preceding 12 months
- Women without sexual activity
- With diabetes mellitus
- Patients with cognitive impairment
- Patients with hormone-dependent tumor
- History of psychiatric illness
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- Patients with liver disease
- Patients with kidney disease
- Users of drugs with proven to decrease sexual desire
- Cardivascular disease, renal disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Effects of Tribulus Terrestris on Sexuality in Postmenopausal Women
Objective: To study the effects of Tribulus terrestris on sexuality in postmenopausal women.
Read the detailed description
Sexuality is an integral part of every personality, influence thoughts, feelings, actions, integrations, and therefore the physical and mental health. It is estimated that 43% of women have at least one complaint of sexual problem. Disorders of desire and arousal are among the most common problems found in gynecologic practice. Medicinal plants have been used for therapeutic purposes for thousands of years, and aphrodisiac properties described in several plants. Tribulus terrestris is a plant indigenous to India, recommended in the treatment of infertility, low libido and impotence, and its main active ingredient protodioscin (PTN).
- Being tested
- Placebo, Tribulus terrestris
- Keywords
- Menopause, Sexual dysfunction, Tribulus, Sexuality, Phytotherapeutic Drugs
- Medical subject headings
- Sexual Dysfunction, Physiological, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called lot 168159
1 tablet/ oral/ 3 times a day for 90 days
Tribulus terrestrisDrug
Also called lot 168059
1 tablet of 250mg/ oral/ 3 times a day for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 1 tablet of placebo/ oral/ 3 times a day for three months Receives: Drug: Placebo |
| Tribulus terrestris | Active comparator | 1 tablet of 250mg/ oral/ 3 times a day for three months Receives: Drug: Tribulus terrestris |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual function in post-menopausal women
Based the questionnaires Golombok-Rust Inventory of Sexual Satisfaction (GRISS) and Sexual Quotient - female version (SQF).
Measured: 90 days
Secondary outcomes (1)
Female Intervention Efficacy Index (FIEI)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startJan 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Functions and Problems in the AdultStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Sonia Maria Rolim Rosa Lima, Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Investigators
- Sonia lima, PhD, Principal investigator, Faculdade de Ciências Médicas da Santa Casa de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407445
- Sponsor's protocol ID
- Fcmscsp-tribulus
- Other IDs
- terrestris
- Status last verified
- Nov 2015
- First submitted
- 1 Aug 2011
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of Tribulus Terrestris on Sexuality in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01407445
- Acronym / sponsor ID
- Fcmscsp-tribulus
- Keywords
- Menopause, Sexual dysfunction, Tribulus, Sexuality, Phytotherapeutic Drugs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jan 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 2 Aug 2011 (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.
Objective: To study the effects of Tribulus terrestris on sexuality in postmenopausal women.
Detailed description
Sexuality is an integral part of every personality, influence thoughts, feelings, actions, integrations, and therefore the physical and mental health. It is estimated that 43% of women have at least one complaint of sexual problem. Disorders of desire and arousal are among the most common problems found in gynecologic practice. Medicinal plants have been used for therapeutic purposes for thousands of years, and aphrodisiac properties described in several plants. Tribulus terrestris is a plant indigenous to India, recommended in the treatment of infertility, low libido and impotence, and its main active ingredient protodioscin (PTN).
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 | Drug: Placebo1 tablet of placebo/ oral/ 3 times a day for three months |
| Tribulus terrestris | Active comparator | Drug: Tribulus terrestris1 tablet of 250mg/ oral/ 3 times a day for three months |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women past menopause, with full autonomy, at least one year of amenorrhea and FSH> 30 mIU / mL.
- Sexually active
- Partner is stable and without sexual difficulties
- Carrier sexual abuse (desire, arousal, orgasm and dyspareunia)
Key exclusion criteria (10 listed)
- Women on hormone therapy within the preceding 12 months
- Women without sexual activity
- With diabetes mellitus
- Patients with cognitive impairment
- Patients with hormone-dependent tumor
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 |
|---|---|---|
| PlaceboAlso: lot 1681591 tablet/ oral/ 3 times a day for 90 days | Drug | Placebo |
| Tribulus terrestrisAlso: lot 1680591 tablet of 250mg/ oral/ 3 times a day for 90 days | Drug | Tribulus terrestris |
Primary outcome
Sexual function in post-menopausal women
Time frame: 90 days
Based the questionnaires Golombok-Rust Inventory of Sexual Satisfaction (GRISS) and Sexual Quotient - female version (SQF).
1 secondary outcome
Female Intervention Efficacy Index (FIEI)
Time frame: 3 months
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 10 Nov 2015.
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.
Sonia lima, PhD principal investigator
Faculdade de Ciências Médicas da Santa Casa de São Paulo
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 Sexual Functions and Problems in the Adult, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo 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 10 Nov 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 function in post-menopausal women (time frame: 90 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 10 Nov 2015.