An observational study in Sexual Disorder, Physiological, sponsored by Centre Hospitalier St Anne. Not yet recruiting. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-28.
Sponsored by Centre Hospitalier St Anne · Observational
The ESPARA study is a multicenter observational research project aiming to monitor, over a three-year period, the evolution of sexual symptoms in male sexual offenders with paraphilia, divided into three groups: receiving antiandrogen treatment, receiving selective serotonin reuptake inhibitors (SSRIs), or no pharmacological treatment. The primary objective is to assess changes in sexual desire intensity and deviant sexual behaviors, while secondary objectives include relapse rates, the role of psychiatric comorbidities, treatment tolerability, and various clinical, cognitive, and life-history factors.
This is a prospective longitudinal cohort study including 200 male participants aged 18-65 years, diagnosed with a paraphilic disorder according to DSM-5, and convicted of sexual offenses (e.g., exhibitionism, rape, sexual assault, incest, possession of child sexual abuse material). Participants are recruited in their usual care setting, after providing informed consent, and assigned to one of three cohorts based on current treatment: antiandrogens, SSRIs, or no pharmacological treatment.
Over a 3-year follow-up period, participants undergo standardized assessments every 3 months, including:
Measurement of sexual desire intensity and deviant sexual symptoms (validated self-report scales).
Recording of any relapses (self-reported, third-party notifications). Evaluation of psychiatric comorbidities (DSM-5), personality disorders (PDQ-4+), impulsivity (BIS-11), and treatment adherence (BARS).
Biological analyses (testosterone levels and others) and regular clinical examinations.
Cognitive and psychological assessments (empathy, denial, cognitive distortions, hypersexuality, alcohol/drug use).
Documentation of traumatic life events (THQ). Optional genetic study through saliva and blood sampling. The study does not initiate or modify treatment; all medical decisions remain under the responsibility of the treating physician. Any adverse effects are systematically documented. Data will be analyzed within each group and, when appropriate, compared between groups after statistical adjustment.
The project is funded by a national PHRC grant and has received ethics committee approval. Additional risks for participants are considered minimal, as all assessments and examinations align with standard care practices.
385 studies on the registry are indexed under Sexual Dysfunction, Physiological; 72 are open to participants now.
This study's planned enrollment of 200 is above the median of 176 across 113 observational studies indexed under Sexual Dysfunction, Physiological.
Browse Sexual Dysfunction, Physiological studies →Centre Hospitalier St Anne is the lead sponsor of 101 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
standard care
Radiation: For subjects on SSRIs: bone densitometry
selective serotonin reuptake inhibitors
Radiation: For subjects on SSRIs: bone densitometry
For subjects on SSRIs: Bone densitometry is one of the additional examinations considered. This assessment is part of the routine monitoring for subjects on androgens.
Also known as: patients on SSRIs
Change in sexual desire and paraphilic behavior scores using the Intensity of Sexual Desire and Sexual Symptoms Scale (ISDSS, self-report)
The ISDSS assesses three domains of sexual functioning during the past month: Sexual interest and desire (score 0-8; higher = stronger desire) Sexual thoughts and fantasies (score 0-8; higher = more frequent/intense fantasies) Frequency of paraphilic sexual activities per week (e.g., masturbation, sexual activity leading to orgasm; reported as count). The mean score of the three domains (range 0-8) will be calculated. Higher scores indicate worse outcome (greater intensity/frequency of paraphilic sexual behavior).
Time frame: Baseline
Sexual relapse occurrence
Number of participants with sexual relapse (recurrence of deviant sexual behavior) during the 36-month follow-up, recorded at each 3-month visit via participant report, third-party notifications, or official records.
Time frame: 3 months
Presence of psychiatric disorders according to DSM-5 criteria
Categorical diagnosis (present/absent) of psychiatric comorbidities assessed at baseline and 36 months using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
Time frame: Baseline and 36 months.
Change in treatment adherence - Brief Adherence Rating Scale
Outcome: Change from baseline in treatment adherence score at 36 months. Measurement: Measured every 3 months using the Brief Adherence Rating Scale (BARS, range 0-6; higher scores indicate better adherence).
Time frame: 3 months
Treatment-related adverse events
Number of participants with treatment-related adverse events during the 36-month follow-up, documented by type, frequency, onset time, and severity, as reported by the treating physician or participant.
Time frame: At baseline
Presence of clinically observable gynecomastia
Binary assessment (present/absent) of gynecomastia at baseline and every 3 months.
Time frame: 3 months.
Traumatic life events (THQ - Trauma History Questionnaire)
Outcome: Total score on the Trauma History Questionnaire (THQ). Measurement: THQ is a self-report questionnaire assessing the presence and frequency of traumatic events over the lifetime. Scale: The French version used in the study includes a series of items scored from 0 (no occurrence) to a maximum determined by the number of events endorsed (higher scores indicate a greater number of traumatic events). Scoring interpretation: Higher scores reflect a worse outcome, meaning greater exposure to traumatic life events.
Time frame: At baseline
Change in clinical management - Comorbidity
Number of participants whose comorbidity profile changes during the 36-month follow-up. Measurement: Recorded at each 3-month visit, based on DSM-5 diagnosis status (present/absent for each condition
Time frame: 3 months
Change in clinical management - Treatment tolerance
Number of participants with changes in clinical management due to treatment-related adverse events. Measurement: Recorded at each 3-month visit; events classified by type, severity, and relationship to treatment (CTCAE v4.0).
Time frame: 3 months
Change in clinical management - Sexual symptoms evolution
Outcome: Change from baseline in sexual symptom scores leading to a modification of clinical management. Measurement: Difference in scores from validated sexual symptoms scales (libido, fantasies, sexual activity), measured every 3 months over 36 months.
Time frame: 3 months
Change in treatment adherence - Serum testosterone level
Outcome: Change from baseline in serum testosterone concentration at 36 months in participants receiving SSRIs or antiandrogens. Measurement: Measured in ng/dL at baseline and when non-adherence is suspected; lower levels are expected in adherent participants on antiandrogen treatment.
Time frame: At 36 months
Personality traits measured with the Personality Diagnostic Questionnaire-4+ (PDQ-4+)
The PDQ-4+ assesses personality disorder traits. Score range 0-100; higher scores indicate more personality disorder traits (worse outcome).
Time frame: Baseline and 36 months.
Impulsivity measured with the Barratt Impulsiveness Scale, Version 11 (BIS-11)
The BIS-11 is a self-report questionnaire of impulsivity. Score range 30-120; higher scores indicate greater impulsivity (worse outcome).
Time frame: Baseline and 36 months.
Change in systolic and diastolic blood pressure (mmHg)
Mean systolic and diastolic blood pressure values measured at baseline and every 3 months.
Time frame: 3 months.
Change in body weight (kg)
Mean weight measured at baseline and every 3 months.
Time frame: 3 months.
Aggression measured with the Molest Scale
Description: Molest Scale score, range \[min-max to be specified\], higher scores indicate greater aggression (worse outcome).
Time frame: 3 months.
Sexual violence risk measured with the Rape Scale
Rape Scale score, range \[min-max\], higher scores indicate higher risk of sexual violence (worse outcome).
Time frame: 3 months.
Empathy score [specify full name of empathy scale]
Range \[min-max\], higher scores indicate greater empathy (better outcome).
Time frame: 3 months.
Denial score [specify full name of denial scale]
Range \[min-max\], higher scores indicate greater denial (worse outcome).
Time frame: 3 months.
Alcohol use measured with the Alcohol Use Disorders Identification Test (AUDIT)
AUDIT total score (0-40). Higher scores indicate more hazardous or harmful drinking (worse outcome).
Time frame: 3 months.
Illicit drug use (type, quantity, duration)
Self-reported consumption of illicit drugs (type, grams/day, duration). Reported at baseline and every 3 months.
Time frame: 3 months.
Hypersexuality screening with PATHOS and PEACCE
PATHOS score range 0-5, PEACCE \[specify range\]. Higher scores indicate higher risk of hypersexuality (worse outcome).
Time frame: 3 months.
Compulsive sexual behavior measured with the Compulsive Sexual Behavior Inventory (CSBI)
CSBI score range \[min-max\], higher scores indicate greater compulsive sexual behavior (worse outcome).
Time frame: 3 months.
Sexual violence risk measured with the STATIC-99
STATIC-99 score range 0-12; higher scores indicate greater risk of sexual violence recidivism (worse outcome).
Time frame: 3 months.
Sexual risk factors measured with the STABLE-2007
STABLE-2007 score range 0-26; higher scores indicate greater dynamic risk factors for sexual recidivism (worse outcome).
Time frame: 3 months.
Cognitive function measured with the Montreal Cognitive Assessment (MoCA)
MoCA score range 0-30; higher scores indicate better cognitive function.
Time frame: Baseline
Cognitive flexibility measured with the Stroop Test
Stroop performance (reaction time in seconds and number of errors). Longer reaction times and more errors indicate worse cognitive function.
Time frame: Baseline
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Start is estimated for Sep 2025; primary completion for Sep 2030, 60 months later.
Of 37 non-industry observational studies under Sexual Dysfunction, Physiological, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 55. This study's planned 60 months is above that.
Counting every sponsor, half of 40 studies reached it within 42 months; a quarter within 11 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Sexual Dysfunction, Physiological →