An interventional study of Tribulus Terrestris and Placebo treatment in Female Sexual Arousal Disorder, sponsored by Kern Pharma, S.L.. Status unknown at 4 sites in Spain. Open to female participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-01-29.
Sponsored by Kern Pharma, S.L. · Not applicable, Interventional, and Treatment
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).
This is the only study on the registry with Kern Pharma, S.L. as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
One tablet per day in the morning through oral administration of Placebo. During three months.
Other: Placebo treatment
The experimental arm will receive a dietary supplement to increase the libido and sexual function
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)
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
Time frame: At baseline, at 6 weeks, at 3 months and at 6 months (optional)
Variations in testosterone levels (total, bioavailable, and free)
Testosterone levels (total, bioavailable and free) in blood
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 3 months
Compliance with treatment - Recount of refounded product by patient.
Recount of product returned at the end of study
Time frame: 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.
Time frame: 3 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tribulus extract