Descriptive Epidemiology Study for Patients With Paraphilia Sex Offenders and Receiving Androgen Antagonists (EPIPARA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01743209
First received: December 4, 2012
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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.


Condition
Paraphilia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Non-interventional Descriptive Epidemiology Study for Patients With Paraphilia Sex Offenders Receiving Androgen Antagonists Treatment

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • current deviant sexual activity assessed with the frequency of deviant sexual activity per month [ Time Frame: first visit (day 1) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients sex offenders with paraphilia and treatment with androgen antagonists

Criteria

Inclusion Criteria:

  • diagnosis of paraphilia based on DSM-IV-TR
  • antecedent of sexual offence

Exclusion Criteria:

  • no diagnostic of paraphilia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01743209

Contacts
Contact: Florence THIBAUT, MD/PhD 0033232884442 florence.thibaut@chu-rouen.fr
Contact: Heloise DELAVENNE, MD 0033232884442 heloise.delavenne@gmail.com

Locations
France
University Hospital of Rouen Recruiting
Rouen, France, 76000
Contact: Florence THIBAUT, MD/PhD    00332884442    florence.thibaut@chu-rouen.fr   
Principal Investigator: Heloise DELAVENNE, MD         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Florence THIBAUT, MD/PhD University Hospital, Rouen
Study Chair: Heloise Delavenne, MD University Hospital, Rouen
Study Chair: Sandrine LAMY, MD University Hospital, Rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01743209     History of Changes
Other Study ID Numbers: 2012/057/HP
Study First Received: December 4, 2012
Last Updated: July 22, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:
androgen antagonists

Additional relevant MeSH terms:
Paraphilias
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Androgen Antagonists
Androgens
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hormones

ClinicalTrials.gov processed this record on July 24, 2014