Thyroid Clinical Trial
Official title:
OBSERVATIONAL STUDY FOR EVALUATIING THE EFFECT OF RESTORING Euthyroidism ON FEMALE SEXUAL FUNCTION
Verified date | March 2020 |
Source | University of Florence |
Contact | Mario Maggi, MD |
m.maggi[@]dfc.unifi.it | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Andrology Unit | Florence |
Lead Sponsor | Collaborator |
---|---|
University of Florence |
Italy,
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
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 |
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