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Completed

NCT Number: NCT01878409

Study of Sexuality in Parkinson Disease

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Sexual Behavior Sexuality Synucleinopathies

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Ca' Granda

Milan, Italy, 20122

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • idiopathic PD
  • marital status
  • age 40-80

Exclusion criteria

  • patients taking PDE

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Registry information

Acronym: Sex-PD

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 17, 2013
Registry last updated
Jun 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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