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Clinical Trials/NCT03093285
NCT03093285
Unknown
Not Applicable

OBSERVATIONAL STUDY FOR EVALUATIING THE EFFECT OF RESTORING Euthyroidism ON FEMALE SEXUAL FUNCTION

University of Florence1 site in 1 country60 target enrollmentJanuary 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sexuality
Sponsor
University of Florence
Enrollment
60
Locations
1
Primary Endpoint
Sexual Dysfunction and dysthyroidism
Last Updated
6 years ago

Overview

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

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

Registry
clinicaltrials.gov
Start Date
January 2017
End Date
January 2021
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mario Maggi

PROFESSOR

University of Florence

Eligibility Criteria

Inclusion Criteria

  • informed consent
  • hyperthyroidic or hypothyroiditic women
  • sexually active women

Exclusion Criteria

  • age \< 18 Y
  • no sexual activity
  • pregnancy
  • psychiatric disease

Outcomes

Primary Outcomes

Sexual Dysfunction and dysthyroidism

Time Frame: 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 Outcomes

  • Weelbeing and dysthyroidism(12 months)
  • Distress related to sexuality and dysthyroidism(12 months)
  • Body image and dysthyroidism(12 months)

Study Sites (1)

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