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Study of Sexuality in Parkinson Disease (Sex-PD)

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ClinicalTrials.gov Identifier: NCT01878409
Recruitment Status : Completed
First Posted : June 17, 2013
Last Update Posted : June 17, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The aim of this study is to evaluate the different aspects of sexual function among adults with Parkinson Disease to develop a treatment and address sexual problems as a routine part of diagnostic workup and therapeutic planning.

Condition or disease
Parkinson Disease

Detailed Description:

Because there is limited literature on sexual function in Parkinson disease, in this study, we examined sexual functioning in a large groups of patients with idiopathic Parkinson Disease compared with healthy subjects in the Italian community. To assess sexual function in PD we used the Brief Index of Sexual Functioning [(BISF-M for man; BISF-W for woman), the International Index of Erectile Function (IIEF) and the Female Sexual Function Index (FSFI). Participants were also assessed by the Beck Depression Inventory (BDI).

This study aimed to provide a thorough epidemiological description of sexual dysfunction in Parkinson's disease. The knowledge of sexual function in PD might help to plan effective interventionist measures and ultimately to optimize patient's and the partner's quality of life.

Parkinson patients (aged 40-80) and 123 healthy controls (aged 40-80) will be recruited from four Italian Movement Disorders Clinics.


Study Design

Study Type : Observational [Patient Registry]
Actual Enrollment : 244 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Study of Sexuality in Parkinson Disease
Study Start Date : January 2010
Primary Completion Date : November 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Parkinson Disease
Patients with Parkinson Disease
Healthy Subjects
Healthy Subjects


Outcome Measures

Primary Outcome Measures :
  1. BISF [ Time Frame: Baseline ]
    Brief Index of Sexual Functioning (BISF-M for man; BISF-W for woman)International Index of Erectile Function (IIEF) Female Sexual Function Index (FSFI)


Secondary Outcome Measures :
  1. BDI [ Time Frame: Baseline ]
    Beck Depression Inventory (BDI) is a 21.-item self report inventory, for measuring the severity of depression in clinical and nonclinical populations.

  2. PDQ8 [ Time Frame: Baseline ]
    Parkinson' Disease Questionnaire-8 (PDQ- 8) is a self completion PRO designed to address aspects of functioning and well-being for those affected by Parkinson's disease.


Eligibility Criteria

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed as having idiopathic PD were recruited from four Italian Movement Disorders Clinics
Criteria

Inclusion Criteria:

  • idiopathic PD
  • marital status
  • age 40-80

Exclusion Criteria:

  • patients taking PDE
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01878409


Locations
Italy
Fondazione IRCCS Ca' Granda
Milano, Italy, 20122
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Investigators
Principal Investigator: Alberto Priori, MD,PhD Fondazione IRCCS Ca' Granda, Università di Milano
More Information

Responsible Party: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT01878409     History of Changes
Other Study ID Numbers: 652
First Posted: June 17, 2013    Key Record Dates
Last Update Posted: June 17, 2013
Last Verified: June 2013

Keywords provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
Sexuality
Parkinson Disease
BISF
IIEF
FSFI

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases