Title
Clinical Trial to Investigate the Effectiveness of a Dietary Supplement in Increasing Libido and Sexual Function in Postmenopausal Women.
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.
Phase
N/ALead Sponsor
Kern Pharma, S.L.Study Type
InterventionalStatus
Unknown statusIndication/Condition
Female Sexual Arousal DisorderIntervention/Treatment
Tribulus Terrestris ...Study Participants
110This 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).
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
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.
One tablet per day in the morning through oral administration of Placebo. During three months.
Inclusion Criteria: Women who report decreased libido and present female sexual arousal disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria Post-menopause. Age between 45 and 65 years. Sexually active. Agreement to participate and to sign the informed consent documents. Exclusion Criteria: Pregnancy. Women who are on hormone replacement therapy or who need to start it. Cancer treatment or a recent history of cancer (<2 years). 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) Fibromyalgia. Treatment for, or a history of, oestrogen-dependent cancer (breast, uterus, endometrium, etc.). Any comorbidity that may interfere with the pathology under study.
