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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01743209
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : September 8, 2014
Information provided by (Responsible Party):
University Hospital, Rouen

Brief 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. 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 or disease

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Study Type : Observational
Actual Enrollment : 213 participants
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
Study Start Date : December 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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

Inclusion Criteria:

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

Exclusion Criteria:

  • no diagnostic of paraphilia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01743209

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University Hospital of Rouen
Rouen, France, 76000
Sponsors and Collaborators
University Hospital, Rouen
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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
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Responsible Party: University Hospital, Rouen Identifier: NCT01743209    
Other Study ID Numbers: 2012/057/HP
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: September 8, 2014
Last Verified: September 2014
Keywords provided by University Hospital, Rouen:
androgen antagonists
Additional relevant MeSH terms:
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Paraphilic Disorders
Mental Disorders