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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03820453
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
Sponsor:
Collaborator:
Analysis and Research Network, S.L
Information provided by (Responsible Party):
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).

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

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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

Resource links provided by the National Library of Medicine


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




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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820453


Locations
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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
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Responsible Party: Kern Pharma, S.L.
ClinicalTrials.gov Identifier: NCT03820453    
Other Study ID Numbers: GYN-GFL-01-2018
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sexual Dysfunctions, Psychological
Mental Disorders