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| Name | Class |
|---|---|
| Analysis and Research Network, S.L | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control group | Placebo Comparator | One tablet per day in the morning through oral administration of Placebo. During three months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tribulus Terrestris | Dietary Supplement | The experimental arm will receive a dietary supplement to increase the libido and sexual function |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At baseline, at 6 weeks, at 3 months and at 6 months (optional) |
| Measure | Description | Time Frame |
|---|---|---|
| Variations in testosterone levels (total, bioavailable, and free) | Testosterone levels (total, bioavailable and free) in blood | Change from baseline to 3 months visit |
| Change in quality of life (QoL) - Measured with Score on the Cervantes Scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CAP Manso | Not yet recruiting | Barcelona | 08015 | Spain | ||
| Fundació Puigvert |
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| Placebo treatment | Other | The control arm will receive a placebo product with similar organoleptic qualities and the same posology characteristics |
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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.
| 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 | 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. | 3 months |
| Compliance with treatment - Recount of refounded product by patient. | Recount of product returned at the end of study | 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. | 3 months |
| Not yet recruiting |
| Barcelona |
| Spain |
| Hospital Clínic, Barcelona | Active, not recruiting | Barcelona | Spain |
| Sexology Institute | Recruiting | Barcelona | Spain |
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| ID | Term |
|---|---|
| C000713868 | Tribulus extract |
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