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

• ClinicalTrials.gov Identifier: NCT03820453
• Recruitment Status: Unknown
• First Posted: January 29, 2019
• Last Update Posted: January 29, 2019
• Sponsor: Kern Pharma, S.L.
• Collaborator: Analysis and Research Network, S.L
• Information provided by (Responsible Party): Kern Pharma, S.L.

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Female Sexual Arousal Disorder	Dietary Supplement: Tribulus Terrestris; Other: Placebo treatment	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: October 29, 2018
• Estimated Primary Completion Date: August 29, 2019
• Estimated Study Completion Date: August 29, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Changes of Score on the Female Sexual Function Index (FSFI) [ Time Frame: 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 :

1. Variations in testosterone levels (total, bioavailable, and free) [ Time Frame: Change from baseline to 3 months visit ]
   Testosterone levels (total, bioavailable and free) in blood
2. Change in quality of life (QoL) - Measured with Score on the Cervantes Scale. [ Time Frame: 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.

3. Number of adverse events [ Time Frame: 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
4. Compliance with treatment - Measured with the Morisky-Green scale [ Time Frame: 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.

5. Compliance with treatment - Recount of refounded product by patient. [ Time Frame: 3 months ]
   Recount of product returned at the end of study
6. Compliance with treatment -Therapeutic adherence [ Time Frame: 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.

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Spain

CAP Manso; Not yet recruiting

Barcelona, Spain, 08015

Fundació Puigvert; Not yet recruiting

Barcelona, Spain

Hospital Clínic, Barcelona; Active, not recruiting

Barcelona, Spain

Sexology Institute; Recruiting

Barcelona, Spain

Contact: Francisca Molero +34 934516598

Sponsors and Collaborators

Kern Pharma, S.L.

Analysis and Research Network, S.L

More Information

• Responsible Party: Kern Pharma, S.L.
• ClinicalTrials.gov Identifier: NCT03820453
• Other Study ID Numbers: GYN-GFL-01-2018
• First Posted: January 29, 2019
• Last Update Posted: January 29, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological; Mental Disorders