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

Study Overview
=================
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).

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.

Conditions
-----------------
Female Sexual Arousal Disorder

Intervention / Treatment
-----------------
* Dietary Supplement: Tribulus Terrestris
* Other: Placebo treatment


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active group<br>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<br>* The experimental arm will receive a dietary supplement to increase the libido and sexual function<br>|
| Placebo Comparator: Control group<br>One tablet per day in the morning through oral administration of Placebo. During three months. | Other: Placebo treatment<br>* The control arm will receive a placebo product with similar organoleptic qualities and the same posology characteristics<br>|

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 |