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.

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).

Study Overview

• Status: Unknown
• Conditions: Female Sexual Arousal Disorder
• Intervention / Treatment: Dietary supplement: Tribulus Terrestris; Other: Placebo treatment

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08015
    • Not yet recruiting
    • CAP Manso
  • Barcelona, Spain
    • Not yet recruiting
    • Fundacio Puigvert
  • Barcelona, Spain
    • Active, not recruiting
    • Hospital Clinic, Barcelona
  • Barcelona, Spain
    • Recruiting
    • Sexology Institute
    • Contact: Francisca Molero; Phone Number: +34 934516598

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At baseline, at 6 weeks, at 3 months and at 6 months (optional)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variations in testosterone levels (total, bioavailable, and free)	Testosterone levels (total, bioavailable and free) in blood	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.	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	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.	3 months
Compliance with treatment - Recount of refounded product by patient.	Recount of product returned at the end of study	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.	3 months

Collaborators and Investigators

• Sponsor: Kern Pharma, S.L.
• Collaborators: Analysis and Research Network, S.L

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2018
• Primary Completion (Anticipated): August 29, 2019
• Study Completion (Anticipated): August 29, 2019

Study Registration Dates

• First Submitted: January 10, 2019
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (Actual): January 29, 2019

Study Record Updates

• Last Update Posted (Actual): January 29, 2019
• Last Update Submitted That Met QC Criteria: January 28, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological
• Other Study ID Numbers: GYN-GFL-01-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No