Female Sexual Arousal DisorderNCT03820453
Clinical Trial to Investigate the Effectiveness of a Dietary Supplement in Increasing Libido and Sexual Function in Postmenopausal Women.
A study testing Tribulus Terrestris in people with Female Sexual Arousal Disorder, run by Kern Pharma, S.L. at 4 sites in Spain.
Trial summary
This clinical Trial will assess the effects of a dietary supplement based on Tribulus terrestris on the libido and sexual function in postmenopausal women, by doing a follow up of the FSFI scale and different variables during 3 months period. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Female Sexual Arousal Disorder
- 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
- 110 participants
- Where
- 4 sitesSpain
- Study dates
- 29 Oct 2018to 29 Aug 2019
- Phase
- Interventional
- 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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who report decreased libido and present female sexual arousal disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria
- Post-menopause.
- Age between 45 and 65 years.
- Sexually active.
- Agreement to participate and to sign the informed consent documents.
Who cannot join
- Pregnancy.
- Women who are on hormone replacement therapy or who need to start it.
- Cancer treatment or a recent history of cancer (<2 years).
- Any of the following treatments: serotonin inhibitors, GABAergics, tricyclics, antipsychotics, beta-blockers, thiazide diuretics, dopaminergics and anxiolytics for chronic problems (patients on treatment with anxiolytics without chronic problems are eligible)
- Fibromyalgia.
- Treatment for, or a history of, oestrogen-dependent cancer (breast, uterus, endometrium, etc.).
- Any comorbidity that may interfere with the pathology under study.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites, 3 recruiting
- Not yet recruiting
CAP Manso
Barcelona, 08015
- Not yet recruiting
Fundació Puigvert
Barcelona
- Active, not recruiting
Hospital Clínic, Barcelona
Barcelona
- Recruiting
Sexology Institute
Barcelona
Francisca Molero, +34 934516598
About this study
Official title: Multicentre, Randomised, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Investigate the Effectiveness of a Dietary Supplement in Increasing Libido and Sexual Function in Postmenopausal Women.
This clinical Trial will assess the effects of a dietary supplement based on Tribulus terrestris on the libido and sexual function in postmenopausal women, by doing a follow up of the FSFI scale and different variables during 3 months period. Participants will be allocated to dietary supplement or placebo, and will attend to 3 visits (baseline, 6 weeks, 12 weeks and at 24 weeks optional).
- Conditions
- Female Sexual Arousal Disorder
- Being tested
- Tribulus Terrestris, Placebo treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tribulus TerrestrisDietary supplement
The experimental arm will receive a dietary supplement to increase the libido and sexual function
Placebo treatmentOther
The control arm will receive a placebo product with similar organoleptic qualities and the same posology characteristics
| Study group | Role | What they receive |
|---|---|---|
| Active group | Experimental | One tablet per day in the morning through oral administration of a dietary supplement containing Tribulus terrestris as the main active ingredient. During three months with the possibility to extend for another three months. Receives: Dietary Supplement: Tribulus Terrestris |
| Control group | Placebo comparator | One tablet per day in the morning through oral administration of Placebo. During three months. Receives: Other: Placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Score on the Female Sexual Function Index (FSFI)
Score on the Female Sexual Function Index (FSFI) Questionnaire on female libido.
The scale has 19 questions divided in 6 Domains. Total score ranges from 2 to 36 with higher scores considered better outcome.
Scale subdomains, their scoring range and factor to the total score is the following:
Domain: Desire, Range [1 - 5] Factor: 0.6 Domain: Arousal, Range [0 - 5] Factor: 0.3 Domain: Lubrication, Range 0 - 5 Factor: 0.3 Domain: Orgasm Range 0 - 5 Factor: 0.4 Domain: Satisfaction Range [0 (or 1) - 5 ] Factor: 0.4 Domain: Pain Range [0-5] Factor: 0.4
Measured: At baseline, at 6 weeks, at 3 months and at 6 months (optional)
Secondary outcomes (6)
Variations in testosterone levels (total, bioavailable, and free)
Testosterone levels (total, bioavailable and free) in blood
Measured: Change from baseline to 3 months visit
Change in quality of life (QoL) - Measured with Score on the Cervantes Scale.
Score on the Cervantes Scale on quality of life.
The scale is composed of 31 questions divided in 4 domains. Each question is punctuated from 0 to 5. And total scale result ranges from 0 to 155, where 0 corresponds to the maximun QoL value and 155 worst value.
Measured: Change from baseline, to 3 months and optional visit at 6 months
Number of adverse events
Number of adverse events (recorded in the investigator's CRF) to assess the tolerability/safety of the product
Measured: Thought the study, an average of 10 months.
Compliance with treatment - Measured with the Morisky-Green scale
The Morisky-Green scale measures treatment adherence with four yes or no questions. In which yes punctuates 0 and no punctuates 1.
Possible result values for the scale goes from 0 to 4 with 4 being a better outcome than 0.
Measured: 3 months
Compliance with treatment - Recount of refounded product by patient.
Recount of product returned at the end of study
Measured: 3 months
Compliance with treatment -Therapeutic adherence
Data will be collected by the investigator at participants visit with a unique question about percentage of intake. It will be considered a good compliance if 80% of the medication has been taken.
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 posted29 Jan 2019
- Study start29 Oct 2018
- Primary completion29 Aug 2019 (estimated)
- Study completion29 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Sexual Arousal DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kern Pharma, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Analysis and Research Network, S.L
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820453
- Sponsor's protocol ID
- GYN-GFL-01-2018
- Status last verified
- Jan 2019
- First submitted
- 10 Jan 2019
- Last updated
- 29 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Randomised, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Investigate the Effectiveness of a Dietary Supplement in Increasing Libido and Sexual Function in Postmenopausal Women.
- ClinicalTrials.gov ID
- NCT03820453
- Acronym / sponsor ID
- GYN-GFL-01-2018
- Conditions
- Female Sexual Arousal Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Kern Pharma, S.L.Industry (pharma, biotech, devices)
- Collaborators
- Analysis and Research Network, S.L
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 29 Aug 2019 (estimated)
- Study completion
- 29 Aug 2019 (estimated)
- First posted
- 29 Jan 2019 (actual)
- 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.
This clinical Trial will assess the effects of a dietary supplement based on Tribulus terrestris on the libido and sexual function in postmenopausal women, by doing a follow up of the FSFI scale and different variables during 3 months period. Participants will be allocated to dietary supplement or placebo, and will attend to 3 visits (baseline, 6 weeks, 12 weeks and at 24 weeks optional).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active group | Experimental | Dietary Supplement: Tribulus TerrestrisOne tablet per day in the morning through oral administration of a dietary supplement containing Tribulus terrestris as the main active ingredient. During three months with the possibility to extend for another three months. |
| Control group | Placebo comparator | Other: Placebo treatmentOne tablet per day in the morning through oral administration of Placebo. During three months. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women who report decreased libido and present female sexual arousal disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria
- Post-menopause.
- Age between 45 and 65 years.
- Sexually active.
- Agreement to participate and to sign the informed consent documents.
Key exclusion criteria (7 listed)
- Pregnancy.
- Women who are on hormone replacement therapy or who need to start it.
- Cancer treatment or a recent history of cancer (<2 years).
- Any of the following treatments: serotonin inhibitors, GABAergics, tricyclics, antipsychotics, beta-blockers, thiazide diuretics, dopaminergics and anxiolytics for chronic problems (patients on treatment with anxiolytics without chronic problems are eligible)
- Fibromyalgia.
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 TerrestrisThe experimental arm will receive a dietary supplement to increase the libido and sexual function | Dietary supplement | Active group |
| Placebo treatmentThe control arm will receive a placebo product with similar organoleptic qualities and the same posology characteristics | Other | Control group |
Primary outcome
Changes of Score on the Female Sexual Function Index (FSFI)
Time frame: At baseline, at 6 weeks, at 3 months and at 6 months (optional)
Score on the Female Sexual Function Index (FSFI) Questionnaire on female libido. The scale has 19 questions divided in 6 Domains. Total score ranges from 2 to 36 with higher scores considered better outcome. Scale subdomains, their scoring range and factor to the total score is the following: Domain: Desire, Range [1 - 5] Factor: 0.6 Domain: Arousal, Range [0 - 5] Factor: 0.3 Domain: Lubrication, Range 0 - 5 Factor: 0.3 Domain: Orgasm Range 0 - 5 Factor: 0.4 Domain: Satisfaction Range [0 (or 1) - 5 ] Factor: 0.4 Domain: Pain Range [0-5] Factor: 0.4
6 secondary outcomes
Variations in testosterone levels (total, bioavailable, and free)
Time frame: Change from baseline to 3 months visit
Change in quality of life (QoL) - Measured with Score on the Cervantes Scale.
Time frame: Change from baseline, to 3 months and optional visit at 6 months
Number of adverse events
Time frame: Thought the study, an average of 10 months.
Compliance with treatment - Measured with the Morisky-Green scale
Time frame: 3 months
Compliance with treatment - Recount of refounded product by patient.
Time frame: 3 months
Compliance with treatment -Therapeutic adherence
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tribulus Terrestris in people with Female Sexual Arousal Disorder, run by Kern Pharma, S.L. at 4 sites in Spain.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Score on the Female Sexual Function Index (FSFI) (time frame: At baseline, at 6 weeks, at 3 months and at 6 months (optional)). 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 29 Jan 2019.