Clinical Trial to Investigate the Effectiveness of a Dietary Supplement in Increasing Libido and Sexual Function in Postmenopausal Women.

Not Applicable

• Conditions: Female Sexual Arousal Disorder
• Interventions: Dietary Supplement: Tribulus Terrestris; Other: Placebo treatment

• Registration Number: NCT03820453
• Lead Sponsor: Kern Pharma, S.L.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-29
• Status Verified: 2019-01
• Study First Submitted: 2019-01-10
• Study First Submitted QC: 2019-01-28
• Last Update Submitted: 2019-01-28
• Study First Posted: 2019-01-29
• Last Update Posted: 2019-01-29
• Primary Completion: 2019-08-29
• Study Completion: 2019-08-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active group	Tribulus Terrestris	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.
Control group	Placebo treatment	One tablet per day in the morning through oral administration of Placebo. During three months.

Primary Outcome Measures

Name	Time	Method
Changes of Score on the Female Sexual Function Index (FSFI)	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

Secondary Outcome Measures

Name	Time	Method
Compliance with treatment - Recount of refounded product by patient.	3 months	Recount of product returned at the end of study
Compliance with treatment - Measured with the Morisky-Green scale	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 -Therapeutic adherence	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.
Variations in testosterone levels (total, bioavailable, and free)	Change from baseline to 3 months visit	Testosterone levels (total, bioavailable and free) in blood
Number of adverse events	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
Change in quality of life (QoL) - Measured with Score on the Cervantes Scale.	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.

Trial Locations

Locations (4)

Hospital Clínic, Barcelona; 🇪🇸 Barcelona, Spain

Fundació Puigvert; 🇪🇸 Barcelona, Spain

CAP Manso; 🇪🇸 Barcelona, Spain

Sexology Institute; 🇪🇸 Barcelona, Spain