Clinical Trial to Investigate the Effectiveness of a Dietary Supplement in Increasing Libido and Sexual Function in Postmenopausal Women.
|ClinicalTrials.gov Identifier: NCT03820453|
Recruitment Status : Unknown
Verified January 2019 by Kern Pharma, S.L..
Recruitment status was: 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.
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|