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Dysthyroidism and Female Sexual Function

Sponsor
University of Florence (Other)
Overall Status
Unknown status
CT.gov ID
NCT03093285
Collaborator
(none)
60
Enrollment
1
Location
48
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to evaluate the incidence of sexual dysfunction in presence of dysthyroidism and the impact of restoring euthyroidism on female sexual function

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Hormonal component plays a crucial role in sexual function. Hypothyroidism and hyperthyroidism may be associated with any form of sexual dysfunction in men but only a few studies reported the relationship between thyroid dysfunction and female sexuality.

    The study is an observational study. An informed consent will be obtained from all patients before the study.

    The aim of the study is:

    • to evaluate the incidence of sexual dysfunction in presence of dysthyroidism and the impact of restoring euthyroidism on female sexual function (evaluated with the Female Sexual Function Index)

    • to evaluate the influence of hormonal changes on the emotional and psychological wellness (evalueted with the Middle Sex Hospital Questionnaire)

    • to evaluate the influence of hormonal changes on the satisfaction of body image (evalueted with the Body Uneasiness Test)

    • to evaluate the influence of hormonal changes on the distress related to sexuality (evaluated with the Female Sexual Distress Scale).

    The investigators espect to enroll a total of 50 sexually active hyperthyroidic/hypothyroidic women in this study in about 7 months. Statistical analyses will be performed using the Statistical Package for the Social Sciences

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    OBSERVATIONAL STUDY FOR EVALUATIING THE EFFECT OF RESTORING Euthyroidism ON FEMALE SEXUAL FUNCTION
    Actual Study Start Date :
    Jan 1, 2017
    Anticipated Primary Completion Date :
    Jan 1, 2021
    Anticipated Study Completion Date :
    Jan 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    dysthyoidic female

    sexually active, hypothyroidic or hyperthyroidic women of childbearing age

    Outcome Measures

    Primary Outcome Measures

    1. Sexual Dysfunction and dysthyroidism [12 months]

      To assess the incidence of sexual dysfunction in the presence of dysthyroidism and the impact of restoring euthyroidism on female sexual function. The investigators will evaluate the difference between the scores of the FSFI (Female Sexual Function Index) questionnaire administered at baseline and after normalization of thyroid function. The test consists of six domains: desire, arousal, orgasm, pain, sexual satisfaction, lubrication. For each domain the total score goes from 0 to 6 (full sexual functionality).

    Secondary Outcome Measures

    1. Weelbeing and dysthyroidism [12 months]

      To evaluate the influence of hormonal changes on the emotional and psychological wellbeing considering the difference between the scores of the MHQ (Middle Sex Hospital Questionnaire) questionnaire administered at baseline and after normalization of thyroid function. The MHQ test is a self-administered questionnaire used for screening of mental disorders. It consists of six areas related to the free anxiety, phobic anxiety, obsessive compulsive symptoms, somatization, depressive symptoms and histrionic-hysterical traits.

    2. Body image and dysthyroidism [12 months]

      To evaluate the influence of hormonal changes on the satisfaction of body image considering the difference between the scores of the BUT (Body Uneasiness Test) questionnaire administered at baseline and after normalization of thyroid function. The test consists of two parts (A and B) which respectively evaluate the degree of severity linked to body image and some sensory events derived from a precise area of the body. A reduction of the score between the baseline and the normalization of thyroid function would indicate an improvement in these aspects.

    3. Distress related to sexuality and dysthyroidism [12 months]

      To evaluate the influence of hormonal changes on the distress related to sexuality considering the difference between the scores of the FSDS (Female Sexual Distress Scale Revised) questionnaire administered at baseline and after normalization of thyroid function. A higher score (0-48) represents a greater sexual distress.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • informed consent

    • hyperthyroidic or hypothyroiditic women

    • sexually active women

    Exclusion Criteria:

    • age < 18 Y

    • no sexual activity

    • pregnancy

    • psychiatric disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Andrology Unit Florence Italy 50139

    Sponsors and Collaborators

    • University of Florence

    Investigators

    • Study Director: mario maggi, MD, Andrology Unit

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mario Maggi, PROFESSOR, University of Florence
    ClinicalTrials.gov Identifier:
    NCT03093285
    Other Study ID Numbers:
    • Andro AOUC 2016 01
    First Posted:
    Mar 28, 2017
    Last Update Posted:
    Mar 25, 2020
    Last Verified:
    Mar 1, 2020

    Study Results

    No Results Posted as of Mar 25, 2020