Clinical Trial to Investigate the Effectiveness of a Dietary Supplement in Increasing Libido and Sexual Function in Postmenopausal Women.
Study Details
Study Description
Brief 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. 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Active group 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. |
Dietary Supplement: Tribulus Terrestris
The experimental arm will receive a dietary supplement to increase the libido and sexual function
|
| Placebo Comparator: Control group One tablet per day in the morning through oral administration of Placebo. During three months. |
Other: Placebo treatment
The control arm will receive a placebo product with similar organoleptic qualities and the same posology characteristics
|
Outcome Measures
Primary Outcome Measures
- Changes of Score on the Female Sexual Function Index (FSFI) [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
Secondary Outcome Measures
- Variations in testosterone levels (total, bioavailable, and free) [Change from baseline to 3 months visit]
Testosterone levels (total, bioavailable and free) in blood
- Change in quality of life (QoL) - Measured with Score on the Cervantes Scale. [Change from baseline, to 3 months and optional visit at 6 months]
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.
- Number of adverse events [Thought the study, an average of 10 months.]
Number of adverse events (recorded in the investigator's CRF) to assess the tolerability/safety of the product
- Compliance with treatment - Measured with the Morisky-Green scale [3 months]
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.
- Compliance with treatment - Recount of refounded product by patient. [3 months]
Recount of product returned at the end of study
- Compliance with treatment -Therapeutic adherence [3 months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women who report decreased libido and present female sexual arousal disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria
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Post-menopause.
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Age between 45 and 65 years.
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Sexually active.
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Agreement to participate and to sign the informed consent documents.
Exclusion Criteria:
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Pregnancy.
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Women who are on hormone replacement therapy or who need to start it.
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Cancer treatment or a recent history of cancer (<2 years).
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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)
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Fibromyalgia.
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Treatment for, or a history of, oestrogen-dependent cancer (breast, uterus, endometrium, etc.).
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Any comorbidity that may interfere with the pathology under study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CAP Manso | Barcelona | Spain | 08015 | |
| 2 | Fundació Puigvert | Barcelona | Spain | ||
| 3 | Hospital Clínic, Barcelona | Barcelona | Spain | ||
| 4 | Sexology Institute | Barcelona | Spain |
Sponsors and Collaborators
- Kern Pharma, S.L.
- Analysis and Research Network, S.L
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GYN-GFL-01-2018