Parkinson DiseaseSex-PDNCT01878409
Study of Sexuality in Parkinson Disease
An observational study of Parkinson Disease, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 244 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2010to Nov 2012
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed as having idiopathic PD were recruited from four Italian Movement Disorders Clinics
Who may be able to join
- idiopathic PD
- marital status
- age 40-80
Who cannot join
- patients taking PDE
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease
- Keywords
- Sexuality, Parkinson Disease, BISF, IIEF, FSFI
- Medical subject headings
- Parkinson Disease, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson Disease | Patients with Parkinson Disease | |
| Healthy Subjects | Healthy Subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline
Secondary outcomes (2)
BDI
Beck Depression Inventory (BDI) is a 21.-item self report inventory, for measuring the severity of depression in clinical and nonclinical populations.
Measured: Baseline
PDQ8
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startJan 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 244 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alberto Priori, MD,PhD, Principal investigator, Fondazione IRCCS Ca' Granda, Università di Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878409
- Sponsor's protocol ID
- 652
- Acronym
- Sex-PD
- Status last verified
- Jun 2013
- First submitted
- 6 Jun 2013
- Last updated
- 17 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Sexuality in Parkinson Disease
- ClinicalTrials.gov ID
- NCT01878409
- Acronym / sponsor ID
- Sex-PD / 652
- Conditions
- Parkinson Disease
- Keywords
- Sexuality, Parkinson Disease, BISF, IIEF, FSFI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 17 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson Disease | – | –Patients with Parkinson Disease |
| Healthy Subjects | – | –Healthy Subjects |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed as having idiopathic PD were recruited from four Italian Movement Disorders Clinics
Key inclusion criteria (3 listed)
- idiopathic PD
- marital status
- age 40-80
Key exclusion criteria (1 listed)
- patients taking PDE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
2 secondary outcomes
BDI
Time frame: Baseline
PDQ8
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Priori, MD,PhD principal investigator
Fondazione IRCCS Ca' Granda, Università di Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BISF (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2013.