Dysthyroidism and Female Sexual Function

Thyroid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03093285
• Other study ID #: Andro AOUC 2016 01
• Status: Recruiting
• Start date: January 2017
• Est. completion date: January 2021

Study information

• Verified date: March 2020
• Source: University of Florence
• Contact: Mario Maggi, MD
• Email: m.maggi[@]dfc.unifi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• informed consent

• hyperthyroidic or hypothyroiditic women

• sexually active women

Exclusion Criteria:

• age < 18 Y

• no sexual activity

• pregnancy

• psychiatric disease

Related Conditions & MeSH terms

• Sexuality
• Thyroid

Locations

Country	Name	City	State
Italy	Andrology Unit	Florence

Sponsors (1)

Lead Sponsor	Collaborator
University of Florence

Country where clinical trial is conducted

Italy, 

References & Publications (8)

Atis G, Dalkilinc A, Altuntas Y, Atis A, Caskurlu T, Ergenekon E. Sexual dysfunction in women with clinical hypothyroidism and subclinical hypothyroidism. J Sex Med. 2010 Jul;7(7):2583-90. doi: 10.1111/j.1743-6109.2010.01815.x. Epub 2010 Apr 20. — View Citation

Battaglia C, Nappi RE, Mancini F, Cianciosi A, Persico N, Busacchi P, Facchinetti F, de Aloysio D. Menstrual cycle-related morphometric and vascular modifications of the clitoris. J Sex Med. 2008 Dec;5(12):2853-61. doi: 10.1111/j.1743-6109.2008.00972.x. E — View Citation

Bhasin S, Enzlin P, Coviello A, Basson R. Sexual dysfunction in men and women with endocrine disorders. Lancet. 2007 Feb 17;369(9561):597-611. Review. — View Citation

Crown S, Crisp AH. A short clinical diagnostic self-rating scale for psychoneurotic patients. The Middlesex Hospital Questionnaire (M.H.Q.). Br J Psychiatry. 1966 Sep;112(490):917-23. — View Citation

Derogatis L, Clayton A, Lewis-D'Agostino D, Wunderlich G, Fu Y. Validation of the female sexual distress scale-revised for assessing distress in women with hypoactive sexual desire disorder. J Sex Med. 2008 Feb;5(2):357-64. Epub 2007 Nov 27. — View Citation

Krassas GE. Thyroid disease and female reproduction. Fertil Steril. 2000 Dec;74(6):1063-70. — View Citation

Oppo A, Franceschi E, Atzeni F, Taberlet A, Mariotti S. Effects of hyperthyroidism, hypothyroidism, and thyroid autoimmunity on female sexual function. J Endocrinol Invest. 2011 Jun;34(6):449-53. doi: 10.3275/7686. Epub 2011 Apr 28. — View Citation

Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual Dysfunction and dysthyroidism	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).	12 months
Secondary	Weelbeing and dysthyroidism	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.	12 months
Secondary	Body image and dysthyroidism	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.	12 months
Secondary	Distress related to sexuality and dysthyroidism	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.	12 months