Clinical trial NCT03093285: Dysthyroidism and Female Sexual Function
Official title: OBSERVATIONAL STUDY FOR EVALUATIING THE EFFECT OF RESTORING Euthyroidism ON FEMALE SEXUAL FUNCTION
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sexuality
Thyroid
Lead sponsor: University of Florence
Sponsor class: OTHER
First posted: 2017-03-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: sexually active, hyperthyroidic or hypothyroiditic women

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Sexual Dysfunction and dysthyroidism
timeFrame: 12 months
Secondary outcomes:
measure: Weelbeing and dysthyroidism
timeFrame: 12 months
measure: Body image and dysthyroidism
timeFrame: 12 months
measure: Distress related to sexuality and dysthyroidism
timeFrame: 12 months
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Andrology Unit
Study officials:
affiliation: Andrology Unit
name: mario maggi, MD
role: STUDY_DIRECTOR
References:
citation: 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.
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. Epub 2008 Aug 28.
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. doi: 10.1016/S0140-6736(07)60280-3.
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. doi: 10.1192/bjp.112.490.917. No abstract available.
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. doi: 10.1111/j.1743-6109.2007.00672.x. Epub 2007 Nov 27.
citation: Krassas GE. Thyroid disease and female reproduction. Fertil Steril. 2000 Dec;74(6):1063-70. doi: 10.1016/s0015-0282(00)01589-2.
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: 10.1007/BF03346712. Epub 2011 Apr 28.
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(2):191-208. doi: 10.1080/009262300278597.