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Dysthyroidism and Female Sexual Function

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03093285
Enrollment
60
Registered
2017-03-28
Start date
2017-01-31
Completion date
2021-01-31
Last updated
2020-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sexuality, Thyroid

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

Interventions

None listed

Sponsors

University of Florence
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Sexual Dysfunction and dysthyroidism12 monthsTo 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

MeasureTime frameDescription
Weelbeing and dysthyroidism12 monthsTo 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.
Body image and dysthyroidism12 monthsTo 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.
Distress related to sexuality and dysthyroidism12 monthsTo 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.

Countries

Italy

Contacts

Primary ContactMario Maggi, MD
m.maggi@dfc.unifi.it
Backup ContactLinda Vignozzi, MD
l.vignozzi@dfc.unifi.it

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026