Sexual Disorder, PhysiologicalESPARANCT07144943
"Evolution of Sexual Symptoms in Paraphilic Sexual Offenders With/Without Antiandrogen or SSRI Treatment"
An observational study of Sexual Disorder, Physiological, run by Centre Hospitalier St Anne.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Sexual Disorder, Physiological
- What is being tested?
- For subjects on SSRIs: bone densitometry
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to Sep 2030
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: * Men suffering from paraphilic disorders (DSM-5 criteria), * Aged between 18 and 65 years, * Sexual offenders (offense or sexual assault including exhibitionism, rape, sexual touching, incest, possession of child pornographic video material) (severity level 1 to 6 according to WFSBP guidelines)
Who may be able to join
- Men suffering from paraphilias (DSM-5 criteria),
- Aged 18 to 65 years,
- Sexual offenders (offense or sexual assault including exhibitionism, rape, sexual touching, incest, possession of pedopornographic video material) (severity level 1 to 6 according to WFSBP recommendations),
- Subject who has given consent,
- Patients covered by social security,
- Satisfactory command of written and spoken French."
Who cannot join
- Subject in prison (regardless of the reason),
- Subject under guardianship (patients under legal supervision may, however, be included),
- Subjects who have committed a sexual offense and do not meet the DSM-5 criteria for paraphilia."
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study on the Observation of the Evolution of Sexual Symptoms in Sexual Offenders With Paraphilia (With or Without Antiandrogen or SSRI Treatments)
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.
Read the detailed description
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.
- Conditions
- Sexual Disorder, Physiological
- Being tested
- For subjects on SSRIs: bone densitometry
- Keywords
- sexual offenders, paraphilia, ESPARA
- Medical subject headings
- Sexual Dysfunction, Physiological, Paraphilic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
For subjects on SSRIs: bone densitometryRadiation
Also called patients on SSRIs
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.
| Study group | Role | What they receive |
|---|---|---|
| patients on antiandrogens | standard care Receives: Radiation: For subjects on SSRIs: bone densitometry | |
| patients on SSRI | selective serotonin reuptake inhibitors Receives: Radiation: For subjects on SSRIs: bone densitometry | |
| patient without pharmacological treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
Secondary outcomes (26)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: At baseline
Presence of clinically observable gynecomastia
Binary assessment (present/absent) of gynecomastia at baseline and every 3 months.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 3 months.
Change in body weight (kg)
Mean weight measured at baseline and every 3 months.
Measured: 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).
Measured: 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).
Measured: 3 months.
Empathy score [specify full name of empathy scale]
Range [min-max], higher scores indicate greater empathy (better outcome).
Measured: 3 months.
Denial score [specify full name of denial scale]
Range [min-max], higher scores indicate greater denial (worse outcome).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 3 months.
Cognitive function measured with the Montreal Cognitive Assessment (MoCA)
MoCA score range 0-30; higher scores indicate better cognitive function.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start15 Sep 2025 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Disorder, PhysiologicalStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe 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
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence THIBAUT, Professor, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144943
- Sponsor's protocol ID
- D24-P008
- Other IDs
- 2024-A01543-44
- Acronym
- ESPARA
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Observation of the Evolution of Sexual Symptoms in Sexual Offenders With Paraphilia (With or Without Antiandrogen or SSRI Treatments)
- ClinicalTrials.gov ID
- NCT07144943
- Acronym / sponsor ID
- ESPARA / D24-P008
- Conditions
- Sexual Disorder, Physiological
- Keywords
- sexual offenders, paraphilia, ESPARA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 28 Aug 2025 (actual)
- 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 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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients on antiandrogens | – | Radiation: For subjects on SSRIs: bone densitometrystandard care |
| patients on SSRI | – | Radiation: For subjects on SSRIs: bone densitometryselective serotonin reuptake inhibitors |
| patient without pharmacological treatment | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Men suffering from paraphilic disorders (DSM-5 criteria), * Aged between 18 and 65 years, * Sexual offenders (offense or sexual assault including exhibitionism, rape, sexual touching, incest, possession of child pornographic video material) (severity level 1 to 6 according to WFSBP guidelines)
Key inclusion criteria (6 listed)
- Men suffering from paraphilias (DSM-5 criteria),
- Aged 18 to 65 years,
- Sexual offenders (offense or sexual assault including exhibitionism, rape, sexual touching, incest, possession of pedopornographic video material) (severity level 1 to 6 according to WFSBP recommendations),
- Subject who has given consent,
- Patients covered by social security,
Key exclusion criteria (3 listed)
- Subject in prison (regardless of the reason),
- Subject under guardianship (patients under legal supervision may, however, be included),
- Subjects who have committed a sexual offense and do not meet the DSM-5 criteria for paraphilia."
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| For subjects on SSRIs: bone densitometryAlso: patients on SSRIsFor subjects on SSRIs: Bone densitometry is one of the additional examinations considered. This assessment is part of the routine monitoring for subjects on androgens. | Radiation | patients on SSRI, patients on antiandrogens |
Primary outcome
Change in sexual desire and paraphilic behavior scores using the Intensity of Sexual Desire and Sexual Symptoms Scale (ISDSS, self-report)
Time frame: Baseline
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).
26 secondary outcomes
Sexual relapse occurrence
Time frame: 3 months
Presence of psychiatric disorders according to DSM-5 criteria
Time frame: Baseline and 36 months.
Change in treatment adherence - Brief Adherence Rating Scale
Time frame: 3 months
Treatment-related adverse events
Time frame: At baseline
Presence of clinically observable gynecomastia
Time frame: 3 months.
Traumatic life events (THQ - Trauma History Questionnaire)
Time frame: At baseline
Change in clinical management - Comorbidity
Time frame: 3 months
Change in clinical management - Treatment tolerance
Time frame: 3 months
Change in clinical management - Sexual symptoms evolution
Time frame: 3 months
Change in treatment adherence - Serum testosterone level
Time frame: At 36 months
Personality traits measured with the Personality Diagnostic Questionnaire-4+ (PDQ-4+)
Time frame: Baseline and 36 months.
Impulsivity measured with the Barratt Impulsiveness Scale, Version 11 (BIS-11)
Time frame: Baseline and 36 months.
Change in systolic and diastolic blood pressure (mmHg)
Time frame: 3 months.
Change in body weight (kg)
Time frame: 3 months.
Aggression measured with the Molest Scale
Time frame: 3 months.
Sexual violence risk measured with the Rape Scale
Time frame: 3 months.
Empathy score [specify full name of empathy scale]
Time frame: 3 months.
Denial score [specify full name of denial scale]
Time frame: 3 months.
Alcohol use measured with the Alcohol Use Disorders Identification Test (AUDIT)
Time frame: 3 months.
Illicit drug use (type, quantity, duration)
Time frame: 3 months.
Hypersexuality screening with PATHOS and PEACCE
Time frame: 3 months.
Compulsive sexual behavior measured with the Compulsive Sexual Behavior Inventory (CSBI)
Time frame: 3 months.
Sexual violence risk measured with the STATIC-99
Time frame: 3 months.
Sexual risk factors measured with the STABLE-2007
Time frame: 3 months.
Cognitive function measured with the Montreal Cognitive Assessment (MoCA)
Time frame: Baseline
Cognitive flexibility measured with the Stroop Test
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Sexual Disorder, Physiological
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
PRP for Sexual Function
Female Sexual Dysfunction, Sexual Dysfunction
Recruiting
Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
RecruitingPhase 4
Assessment of the Value of FAPI and FDG-PET-CT in Diagnosis of Acute Phase Peyronie's Disease
Peyronie's Disease
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.
Florence THIBAUT, Professor principal investigator
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual Disorder, Physiological, run by Centre Hospitalier St Anne.
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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florence THIBAUT, Professor (01 58411679 ext. +(33), florence.thibaut@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sexual desire and paraphilic behavior scores using the Intensity of Sexual Desire and Sexual Symptoms Scale (ISDSS, self-report) (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 28 Aug 2025.