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

Last updated: January 28, 2019
Sponsor: Kern Pharma, S.L.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sexual Dysfunction

Treatment

N/A

Clinical Study ID

NCT03820453
GYN-GFL-01-2018
  • Ages 45-65
  • Female

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women who report decreased libido and present female sexual arousal disorder accordingto 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

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 forchronic problems (patients on treatment with anxiolytics without chronic problems areeligible)

  • 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 Design

Total Participants: 110
Study Start date:
October 29, 2018
Estimated Completion Date:
August 29, 2019

Connect with a study center

  • CAP Manso

    Barcelona, 08015
    Spain

    Site Not Available

  • Fundació Puigvert

    Barcelona,
    Spain

    Site Not Available

  • Hospital Clínic, Barcelona

    Barcelona,
    Spain

    Site Not Available

  • Sexology Institute

    Barcelona,
    Spain

    Active - Recruiting

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