SexualityNCT03093285
Dysthyroidism and Female Sexual Function
An observational study of Sexuality and Thyroid, run by University of Florence at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2017to Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: sexually active, hyperthyroidic or hypothyroiditic women
Who may be able to join
- informed consent
- hyperthyroidic or hypothyroiditic women
- sexually active women
Who cannot join
- age < 18 Y
- no sexual activity
- pregnancy
- psychiatric disease
Trial locations and contacts
1 site in 1 country.
Mario Maggi, MD contact
Linda Vignozzi, MD contact
Italy1 site, 1 recruiting
- Recruiting
Andrology Unit
Florence, 50139
mario maggi, MD
About this study
Official title: OBSERVATIONAL STUDY FOR EVALUATIING THE EFFECT OF RESTORING Euthyroidism ON FEMALE SEXUAL FUNCTION
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
Read the 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
- Medical subject headings
- Sexuality, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| dysthyoidic female | sexually active, hypothyroidic or hyperthyroidic women of childbearing age |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study startJan 2017
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for SexualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Maggi, University of Florence
- Investigators
- mario maggi, MD, Study director, Andrology Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093285
- Sponsor's protocol ID
- Andro AOUC 2016 01
- Status last verified
- Mar 2020
- First submitted
- 16 Feb 2017
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20412428Battaglia 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.
PubMed 18761595Bhasin 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.
PubMed 17307107Crown 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.
PubMed 5970912Derogatis 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.
PubMed 18042215Krassas GE. Thyroid disease and female reproduction. Fertil Steril. 2000 Dec;74(6):1063-70. doi: 10.1016/s0015-0282(00)01589-2.
PubMed 11119728Oppo 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.
PubMed 21532331Rosen 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.
PubMed 10782451
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OBSERVATIONAL STUDY FOR EVALUATIING THE EFFECT OF RESTORING Euthyroidism ON FEMALE SEXUAL FUNCTION
- ClinicalTrials.gov ID
- NCT03093285
- Acronym / sponsor ID
- Andro AOUC 2016 01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 28 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dysthyoidic female | – | –sexually active, hypothyroidic or hyperthyroidic women of childbearing age |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- sexually active, hyperthyroidic or hypothyroiditic women
Key inclusion criteria (3 listed)
- informed consent
- hyperthyroidic or hypothyroiditic women
- sexually active women
Key exclusion criteria (4 listed)
- age < 18 Y
- no sexual activity
- pregnancy
- psychiatric disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sexual Dysfunction and dysthyroidism
Time frame: 12 months
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).
3 secondary outcomes
Weelbeing and dysthyroidism
Time frame: 12 months
Body image and dysthyroidism
Time frame: 12 months
Distress related to sexuality and dysthyroidism
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Results publication: PubMed 20412428Atis 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.
- Results publication: PubMed 18761595Battaglia 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.
- Results publication: PubMed 17307107Bhasin 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.
- Results publication: PubMed 5970912Crown 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.
- Results publication: PubMed 18042215Derogatis 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.
- Results publication: PubMed 11119728Krassas GE. Thyroid disease and female reproduction. Fertil Steril. 2000 Dec;74(6):1063-70. doi: 10.1016/s0015-0282(00)01589-2.
- Results publication: PubMed 21532331Oppo 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.
- Results publication: PubMed 10782451Rosen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Maggi, MD contact
Linda Vignozzi, MD contact
mario maggi, MD study director
Andrology Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexuality and Thyroid, run by University of Florence at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mario Maggi, MD (m.maggi@dfc.unifi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Dysfunction and dysthyroidism (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03093285, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.