NCT00148200

Brief Summary

Purposes of this study are:

  • To determine the prevalence of female sexual dysfunctions among Italian general population
  • To determine which sexual domains are more frequently compromised
  • To evaluate which of the factors we took into consideration are more frequently associated with FSD

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2005

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

February 18, 2009

Status Verified

February 1, 2009

Enrollment Period

1.7 years

First QC Date

September 2, 2005

Last Update Submit

February 17, 2009

Conditions

Sexual Dysfunctions, Psychological

Keywords

female sexual dysfunctiondesirearousallubrificationorgasmsatisfactionpain

Eligibility Criteria

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

n° 500 Female outpatient coming to Gynecology Clinic

You may qualify if:

  • Female outpatient coming to Gynecology Clinic
  • Age \>18

You may not qualify if:

  • Pregnancy
  • Never had sexual activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic of Obstetrics and Gynecology - S. Orsola Hospital

Bologna, 40138, Italy

Location

Related Publications (11)

  • Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: prevalence and predictors. JAMA. 1999 Feb 10;281(6):537-44. doi: 10.1001/jama.281.6.537.

    PMID: 10022110BACKGROUND

  • Basson R, Berman J, Burnett A, Derogatis L, Ferguson D, Fourcroy J, Goldstein I, Graziottin A, Heiman J, Laan E, Leiblum S, Padma-Nathan H, Rosen R, Segraves K, Segraves RT, Shabsigh R, Sipski M, Wagner G, Whipple B. Report of the international consensus development conference on female sexual dysfunction: definitions and classifications. J Urol. 2000 Mar;163(3):888-93.

    PMID: 10688001BACKGROUND

  • Berman JR, Berman LA, Werbin TJ, Goldstein I. Female sexual dysfunction: anatomy, physiology, evaluation and treatment options. Curr Opin Urol. 1999 Nov;9(6):563-8. doi: 10.1097/00042307-199911000-00012.

    PMID: 10668578BACKGROUND

  • Geiss IM, Umek WH, Dungl A, Sam C, Riss P, Hanzal E. Prevalence of female sexual dysfunction in gynecologic and urogynecologic patients according to the international consensus classification. Urology. 2003 Sep;62(3):514-8. doi: 10.1016/s0090-4295(03)00487-4.

    PMID: 12946757BACKGROUND

  • Abdo CH, Oliveira WM Jr, Moreira ED Jr, Fittipaldi JA. Prevalence of sexual dysfunctions and correlated conditions in a sample of Brazilian women--results of the Brazilian study on sexual behavior (BSSB). Int J Impot Res. 2004 Apr;16(2):160-6. doi: 10.1038/sj.ijir.3901198.

    PMID: 14961047BACKGROUND

  • Najman JM, Dunne MP, Boyle FM, Cook MD, Purdie DM. Sexual dysfunction in the Australian population. Aust Fam Physician. 2003 Nov;32(11):951-4.

    PMID: 14650796BACKGROUND

  • Salonia A, Munarriz RM, Naspro R, Nappi RE, Briganti A, Chionna R, Federghini F, Mirone V, Rigatti P, Goldstein I, Montorsi F. Women's sexual dysfunction: a pathophysiological review. BJU Int. 2004 May;93(8):1156-64. doi: 10.1111/j.1464-410X.2004.04796.x. No abstract available.

    PMID: 15142131BACKGROUND

  • 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: 10782451BACKGROUND

  • Wiegel M, Meston C, Rosen R. The female sexual function index (FSFI): cross-validation and development of clinical cutoff scores. J Sex Marital Ther. 2005 Jan-Feb;31(1):1-20. doi: 10.1080/00926230590475206.

    PMID: 15841702BACKGROUND

  • Bancroft J, Loftus J, Long JS. Distress about sex: a national survey of women in heterosexual relationships. Arch Sex Behav. 2003 Jun;32(3):193-208. doi: 10.1023/a:1023420431760.

    PMID: 12807292BACKGROUND

  • Lightner DJ. Female sexual dysfunction. Mayo Clin Proc. 2002 Jul;77(7):698-702. doi: 10.4065/77.7.698.

    PMID: 12108607BACKGROUND

MeSH Terms

Conditions

Sexual Dysfunctions, PsychologicalOrgasmPersonal SatisfactionPain

Condition Hierarchy (Ancestors)

Mental DisordersSexual BehaviorBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maria Cristina Meriggiola, MD

    University of Bologna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 7, 2005

Study Start

February 1, 2005

Primary Completion

November 1, 2006

Study Completion

February 1, 2007

Last Updated

February 18, 2009

Record last verified: 2009-02

Locations

IT(1)