Clinical trial NCT03820453: Clinical Trial to Investigate the Effectiveness of a Dietary Supplement in Increasing Libido and Sexual Function in Postmenopausal Women.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Female Sexual Arousal Disorder
Lead sponsor: Kern Pharma, S.L.
Sponsor class: INDUSTRY
Collaborators: name: Analysis and Research Network, S.L
First posted: 2019-01-29
Enrollment: 110
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Changes of Score on the Female Sexual Function Index (FSFI)
timeFrame: At baseline, at 6 weeks, at 3 months and at 6 months (optional)
Secondary outcomes:
measure: Variations in testosterone levels (total, bioavailable, and free)
timeFrame: Change from baseline to 3 months visit
measure: Change in quality of life (QoL) - Measured with Score on the Cervantes Scale.
timeFrame: Change from baseline, to 3 months and optional visit at 6 months
measure: Number of adverse events
timeFrame: Thought the study, an average of 10 months.
measure: Compliance with treatment - Measured with the Morisky-Green scale
timeFrame: 3 months
measure: Compliance with treatment - Recount of refounded product by patient.
timeFrame: 3 months
measure: Compliance with treatment -Therapeutic adherence
timeFrame: 3 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: CAP Manso
city: Barcelona
country: Spain
facility: Fundació Puigvert
city: Barcelona
country: Spain
facility: Hospital Clínic, Barcelona
city: Barcelona
country: Spain
facility: Sexology Institute
Study officials:
References: