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

N/AUnknownNCT03820453

Kern Pharma, S.L.110 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

110

Conditions

Female Sexual Arousal Disorder

Interventions

Tribulus TerrestrisDIETARY_SUPPLEMENT

The experimental arm will receive a dietary supplement to increase the libido and sexual function

Placebo treatmentOTHER

The control arm will receive a placebo product with similar organoleptic qualities and the same posology characteristics

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (4)

CAP Manso

Barcelona, Spain

NOT_YET_RECRUITING

Fundació Puigvert

Barcelona, Spain

NOT_YET_RECRUITING

Hospital Clínic, Barcelona

Barcelona, Spain

ACTIVE_NOT_RECRUITING

Sexology Institute

Barcelona, Spain

Outcomes

Primary Outcomes

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

Time frame: At baseline, at 6 weeks, at 3 months and at 6 months (optional)

Secondary Outcomes

Variations in testosterone levels (total, bioavailable, and free)

Testosterone levels (total, bioavailable and free) in blood

Time frame: 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.

Time frame: 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

Time frame: 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.

Data from ClinicalTrials.gov

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