NCT03093285

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 28, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

4 years

First QC Date

February 16, 2017

Last Update Submit

March 24, 2020

Conditions

SexualityThyroid

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Weelbeing and dysthyroidism

    12 months

  • Body image and dysthyroidism

    12 months

  • Distress related to sexuality and dysthyroidism

    12 months

Study Arms (1)

dysthyoidic female

sexually active, hypothyroidic or hyperthyroidic women of childbearing age

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

sexually active, hyperthyroidic or hypothyroiditic women

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andrology Unit

Florence, 50139, Italy

RECRUITING

Related 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.

    PMID: 20412428RESULT

  • 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.

    PMID: 18761595RESULT

  • 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.

    PMID: 17307107RESULT

  • 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.

    PMID: 5970912RESULT

  • 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.

    PMID: 18042215RESULT

  • Krassas GE. Thyroid disease and female reproduction. Fertil Steril. 2000 Dec;74(6):1063-70. doi: 10.1016/s0015-0282(00)01589-2.

    PMID: 11119728RESULT

  • 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.

    PMID: 21532331RESULT

  • 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.

    PMID: 10782451RESULT

MeSH Terms

Conditions

SexualityThyroid Diseases

Condition Hierarchy (Ancestors)

Sexual BehaviorBehaviorEndocrine System Diseases

Study Officials

  • mario maggi, MD

    Andrology Unit

    STUDY DIRECTOR

Central Study Contacts

Mario Maggi, MD

CONTACT

m.maggi@dfc.unifi.it

Linda Vignozzi, MD

CONTACT

l.vignozzi@dfc.unifi.it

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROFESSOR

Study Record Dates

First Submitted

February 16, 2017

First Posted

March 28, 2017

Study Start

January 1, 2017

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations

IT(1)