Clinical Trial to Investigate the Effectiveness of a Dietary Supplement in Increasing Libido and Sexual Function in Postmenopausal Women.
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|ClinicalTrials.gov Identifier: NCT03820453|
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Female Sexual Arousal Disorder||Dietary Supplement: Tribulus Terrestris Other: Placebo treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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.|
|Actual Study Start Date :||October 29, 2018|
|Estimated Primary Completion Date :||August 29, 2019|
|Estimated Study Completion Date :||August 29, 2019|
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
- 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
- Variations in testosterone levels (total, bioavailable, and free) [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 3 months ]Recount of product returned at the end of study
- Compliance with treatment -Therapeutic adherence [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820453
|CAP Manso||Not yet recruiting|
|Barcelona, Spain, 08015|
|Fundació Puigvert||Not yet recruiting|
|Hospital Clínic, Barcelona||Active, not recruiting|
|Contact: Francisca Molero +34 934516598|