Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2017-01-31
2021-01-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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dysthyoidic female
sexually active, hypothyroidic or hyperthyroidic women of childbearing age
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* hyperthyroidic or hypothyroiditic women
* sexually active women
Exclusion Criteria
* no sexual activity
* pregnancy
* psychiatric disease
18 Years
FEMALE
No
Sponsors
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University of Florence
OTHER
Responsible Party
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Mario Maggi
PROFESSOR
Principal Investigators
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mario maggi, MD
Role: STUDY_DIRECTOR
Andrology Unit
Locations
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Andrology Unit
Florence, , Italy
Countries
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Central Contacts
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Facility Contacts
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mario maggi, MD
Role: primary
References
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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.
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.
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.
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.
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.
Krassas GE. Thyroid disease and female reproduction. Fertil Steril. 2000 Dec;74(6):1063-70. doi: 10.1016/s0015-0282(00)01589-2.
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.
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.
Other Identifiers
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Andro AOUC 2016 01
Identifier Type: -
Identifier Source: org_study_id
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