NCT01878409

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
244

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

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

January 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 17, 2013

Completed
Last Updated

June 17, 2013

Status Verified

June 1, 2013

Enrollment Period

2.8 years

First QC Date

June 6, 2013

Last Update Submit

June 14, 2013

Conditions

Parkinson Disease

Keywords

SexualityParkinson DiseaseBISFIIEFFSFI

Outcome Measures

Primary Outcomes (1)

  • BISF

    Brief Index of Sexual Functioning (BISF-M for man; BISF-W for woman)International Index of Erectile Function (IIEF) Female Sexual Function Index (FSFI)

    Baseline

Secondary Outcomes (2)

  • BDI

    Baseline

  • PDQ8

    Baseline

Study Arms (2)

Parkinson Disease

Patients with Parkinson Disease

Healthy Subjects

Healthy Subjects

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed as having idiopathic PD were recruited from four Italian Movement Disorders Clinics

You may qualify if:

  • idiopathic PD
  • marital status
  • age 40-80

You may not qualify if:

  • patients taking PDE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Ca' Granda

Milan, Italy, 20122, Italy

Location

MeSH Terms

Conditions

Parkinson DiseaseSexuality

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesSexual BehaviorBehavior

Study Officials

  • Alberto Priori, MD,PhD

    Fondazione IRCCS Ca' Granda, Università di Milano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2013

First Posted

June 17, 2013

Study Start

January 1, 2010

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

June 17, 2013

Record last verified: 2013-06

Locations

IT(1)