ParaphiliaEPIPARANCT01743209
Descriptive Epidemiology Study for Patients With Paraphilia Sex Offenders and Receiving Androgen Antagonists
An observational study of Paraphilia, run by University Hospital, Rouen at 1 site in France.
Trial summary
The main objective of the study is to describe the french population of individuals with paraphilia who have committed a sexual offence in whom androgen antagonists was prescribed. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Paraphilia
- How many people
- 213 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2012to Jun 2014
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients sex offenders with paraphilia and treatment with androgen antagonists
Who may be able to join
- diagnosis of paraphilia based on DSM-IV-TR
- antecedent of sexual offence
Who cannot join
- no diagnostic of paraphilia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Non-interventional Descriptive Epidemiology Study for Patients With Paraphilia Sex Offenders Receiving Androgen Antagonists Treatment
The main objective of the study is to describe the french population of individuals with paraphilia who have committed a sexual offence in whom androgen antagonists was prescribed. The secondary objectives are the description of social demographic profiles, the personal and family histories,psychiatric co-morbidities, the side effects of androgen antagonists treatment. This study, the first of its kind in France, may allow to better understand the social demographic and clinical profile of sexual offenders with paraphilias treated with androgen antagonists.
To be included, the subject must have committed a sexual offense and must present a diagnosis of paraphilia with an indication of treatment with androgen antagonists. Paraphilia is defined by the Diagnostic and Statistical Manual as a sexual behavior disorder characterized by "sexually arousing fantasies, needs or recurrent and intense sexual behaviors generally involving (1) of non-human objects, (2) the suffering or humiliation of oneself or partner, (3) children or other persons without their consent, occurring during a period of at least six months "(Criterion A). This disorder is responsible for sexual behavior which is "clinically significant disturbances in social, occupational or other important areas of functioning" (Criterion B).
Read more
The inclusion of approximately 200 subjects is expected in this study. The inclusion period will last for 12 months.
Data will be codified and only a few investigators will have access to these data. The statistical analyse will use the usual descriptive parameters: mean, standard deviation, median, interquartile range and range for quantitative variables, frequencies and cumulative frequencies (if applicable) for qualitative variables.
- Conditions
- Paraphilia
- Keywords
- androgen antagonists
- Medical subject headings
- Paraphilic Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
current deviant sexual activity assessed with the frequency of deviant sexual activity per month
The primary outcome measure concerns the patient current deviant sexual activity. These data are reported routinely by the patient during his medical consultation and consigned in the medical record.
Measured: first visit (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParaphiliaStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence THIBAUT, MD/PhD, Principal investigator, University Hospital, RouenHeloise Delavenne, MD, Study chair, University Hospital, RouenSandrine LAMY, MD, Study chair, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743209
- Sponsor's protocol ID
- 2012/057/HP
- Acronym
- EPIPARA
- Status last verified
- Sep 2014
- First submitted
- 4 Dec 2012
- Last updated
- 8 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Non-interventional Descriptive Epidemiology Study for Patients With Paraphilia Sex Offenders Receiving Androgen Antagonists Treatment
- ClinicalTrials.gov ID
- NCT01743209
- Acronym / sponsor ID
- EPIPARA / 2012/057/HP
- Conditions
- Paraphilia
- Keywords
- androgen antagonists
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 6 Dec 2012 (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 main objective of the study is to describe the french population of individuals with paraphilia who have committed a sexual offence in whom androgen antagonists was prescribed. The secondary objectives are the description of social demographic profiles, the personal and family histories,psychiatric co-morbidities, the side effects of androgen antagonists treatment. This study, the first of its kind in France, may allow to better understand the social demographic and clinical profile of sexual offenders with paraphilias treated with androgen antagonists.
To be included, the subject must have committed a sexual offense and must present a diagnosis of paraphilia with an indication of treatment with androgen antagonists. Paraphilia is defined by the Diagnostic and Statistical Manual as a sexual behavior disorder characterized by "sexually arousing fantasies, needs or recurrent and intense sexual behaviors generally involving (1) of non-human objects, (2) the suffering or humiliation of oneself or partner, (3) children or other persons without their consent, occurring during a period of at least six months "(Criterion A). This disorder is responsible for sexual behavior which is "clinically significant disturbances in social, occupational or other important areas of functioning" (Criterion B).
The inclusion of approximately 200 subjects is expected in this study. The inclusion period will last for 12 months.
Data will be codified and only a few investigators will have access to these data. The statistical analyse will use the usual descriptive parameters: mean, standard deviation, median, interquartile range and range for quantitative variables, frequencies and cumulative frequencies (if applicable) for qualitative variables.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients sex offenders with paraphilia and treatment with androgen antagonists
Key inclusion criteria (2 listed)
- diagnosis of paraphilia based on DSM-IV-TR
- antecedent of sexual offence
Key exclusion criteria (1 listed)
- no diagnostic of paraphilia
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
current deviant sexual activity assessed with the frequency of deviant sexual activity per month
Time frame: first visit (day 1)
The primary outcome measure concerns the patient current deviant sexual activity. These data are reported routinely by the patient during his medical consultation and consigned in the medical record.
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 8 Sep 2014.
Related trials for Paraphilia
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A Group Based Psychoeducational Intervention for Partners of Child Sexual Abuse Material Offenders.
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RecruitingObservational study
Paraphilic Disorders and Other Conditions With Risk for Sexual Violence: a Case-control Study
Paraphilic Disorders, Sexual Addiction
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Psychological Treatment for Paraphilic Disorders
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Not yet recruitingObservational study
"Evolution of Sexual Symptoms in Paraphilic Sexual Offenders With/Without Antiandrogen or SSRI Treatment"
Sexual Disorder, Physiological
Recruiting
Talking for Change: Secondary Prevention of Child Sexual Abuse Perpetration
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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.
Florence THIBAUT, MD/PhD principal investigator
University Hospital, Rouen
Heloise Delavenne, MD study chair
University Hospital, Rouen
Sandrine LAMY, MD study chair
University Hospital, Rouen
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 Paraphilia, run by University Hospital, Rouen at 1 site in France.
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 2 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 8 Sep 2014. 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 France. 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?
current deviant sexual activity assessed with the frequency of deviant sexual activity per month (time frame: first visit (day 1)). 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 8 Sep 2014.