PedophiliaPhase 3PCNETNCT00601276
Comparison of Two Pharmacological Treatments of Pedophilia
A Phase 3 study testing leuprorelin and Cyproterone acetate in people with Pedophilia, run by Institut National de la Santé Et de la Recherche Médicale, France at 4 sites in France.
Trial summary
Sexual abuse committed on children is a major public health problem because of its frequency and its severe consequences on the mental health of victims. Objective: to compare the therapeutic efficacy of cyproterone acetate (CPA) and leuprolide, with the hypothesis that leuprolide will be more effective. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Pedophilia
- What is being tested?
- leuprorelin and Cyproterone acetate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 4 sitesFrance
- Study dates
- Dec 2007to Jun 2009
- Phase
- Phase 3
- 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 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- clinical diagnosis of pedophilia
- high frequency of sexual urges and deviant behavior as demonstrated by a score equal to 8 on the scale of Rösler \& Witztum (Rösler \& Witztum, 1998) ;
- age: 18-60 years
- informed consent
Who cannot join
- IQ<70
- schizophrenia, schizoaffective disorder, or delusional disorder
- already receiving one of the tested drugs
- contraindication for one of the tested drugs
- no current or planned incarceration
Trial locations and contacts
4 sites in 1 country.
France4 sites
Federation d'Endocrinologie, Hopital NeuroCardiologique
Bron, 69500
Centre MédicoPsychologique CMPG21, EPS Perray Vaucluse
Paris, 75017
Service de Psychiatrie, Hopital Foch
Suresnes, 92150
SMPR, Hopital Paul Guiraud
Villejuif, 94800
About this study
Official title: Comparative Controlled Clinical Trial of Two Pharmacological Treatments of Pedophilia
Sexual abuse committed on children is a major public health problem because of its frequency and its severe consequences on the mental health of victims.
Objective: to compare the therapeutic efficacy of cyproterone acetate (CPA) and leuprolide, with the hypothesis that leuprolide will be more effective.
- Conditions
- Pedophilia
- Being tested
- leuprorelin, Cyproterone acetate
- Keywords
- pedophilia, antiandrogens, gonadotropin releasing hormone agonists
- Medical subject headings
- Pedophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leuprorelinDrug
Also called Enantone
Subcutaneous injection, 3.75 mg every 4 weeks
Cyproterone acetateDrug
Also called Androcur
2.0 mg/kg/day, tablet, per os
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: leuprorelin |
| 2 | Active comparator | Not described Receives: Drug: Cyproterone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire on sexual behavior
Measured: prospective
Secondary outcomes (1)
Recidivism
Measured: Prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: This decision is based on the stop-rule established in Amendment N°.2 to the protocol, which called for halting the study if the number of participants enrolled was less than 12 by March 31, 2009 : 6 out of 48 participants were enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PedophiliaStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Assistance Publique - Hôpitaux de Paris, Ministry of Health, France, Ministry of Higher Education and Research, France
- Responsible party
- Sponsor
- Investigators
- Serge Stoleru, MD, PHD, Study director, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00601276
- Sponsor's protocol ID
- RBM-0315
- Acronym
- PCNET
- Status last verified
- Dec 2007
- First submitted
- 3 Dec 2007
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moulier V, Fonteille V, Pelegrini-Issac M, Cordier B, Baron-Laforet S, Boriasse E, Durand E, Stoleru S. A pilot study of the effects of gonadotropin-releasing hormone agonist therapy on brain activation pattern in a man with pedophilia. Int J Offender Ther Comp Criminol. 2012 Feb;56(1):50-60. doi: 10.1177/0306624X10392191. Epub 2011 Apr 24.
PubMed 21518701
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Controlled Clinical Trial of Two Pharmacological Treatments of Pedophilia
- ClinicalTrials.gov ID
- NCT00601276
- Acronym / sponsor ID
- PCNET / RBM-0315
- Conditions
- Pedophilia
- Keywords
- pedophilia, antiandrogens, gonadotropin releasing hormone agonists
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This decision is based on the stop-rule established in Amendment N°.2 to the protocol, which called for halting the study if the number of participants enrolled was less than 12 by March 31, 2009 : 6 out of 48 participants were enrolled
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- Assistance Publique - Hôpitaux de Paris, Ministry of Health, France, Ministry of Higher Education and Research, France
- Study start
- Dec 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 28 Jan 2008 (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.
Sexual abuse committed on children is a major public health problem because of its frequency and its severe consequences on the mental health of victims.
Objective: to compare the therapeutic efficacy of cyproterone acetate (CPA) and leuprolide, with the hypothesis that leuprolide will be more effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: leuprorelin |
| 2 | Active comparator | Drug: Cyproterone acetate |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- clinical diagnosis of pedophilia
- high frequency of sexual urges and deviant behavior as demonstrated by a score equal to 8 on the scale of Rösler \& Witztum (Rösler \& Witztum, 1998) ;
- age: 18-60 years
- informed consent
Key exclusion criteria (5 listed)
- IQ<70
- schizophrenia, schizoaffective disorder, or delusional disorder
- already receiving one of the tested drugs
- contraindication for one of the tested drugs
- no current or planned incarceration
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 |
|---|---|---|
| leuprorelinAlso: EnantoneSubcutaneous injection, 3.75 mg every 4 weeks | Drug | 1 |
| Cyproterone acetateAlso: Androcur2.0 mg/kg/day, tablet, per os | Drug | 2 |
Primary outcome
Questionnaire on sexual behavior
Time frame: prospective
1 secondary outcome
Recidivism
Time frame: Prospective
Results and safety
The study was stopped early (reason given: This decision is based on the stop-rule established in Amendment N°.2 to the protocol, which called for halting the study if the number of participants enrolled was less than 12 by March 31, 2009 : 6 out of 48 participants were enrolled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Derived from this study: PubMed 21518701Moulier V, Fonteille V, Pelegrini-Issac M, Cordier B, Baron-Laforet S, Boriasse E, Durand E, Stoleru S. A pilot study of the effects of gonadotropin-releasing hormone agonist therapy on brain activation pattern in a man with pedophilia. Int J Offender Ther Comp Criminol. 2012 Feb;56(1):50-60. doi: 10.1177/0306624X10392191. Epub 2011 Apr 24.
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Pedophilia
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.
Serge Stoleru, MD, PHD study director
Institut National de la Santé Et de la Recherche Médicale, France
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing leuprorelin and Cyproterone acetate in people with Pedophilia, run by Institut National de la Santé Et de la Recherche Médicale, France at 4 sites 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This decision is based on the stop-rule established in Amendment N°.2 to the protocol, which called for halting the study if the number of participants enrolled was less than 12 by March 31, 2009 : 6 out of 48 participants were enrolled). Results are not available in the source record.
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?
Questionnaire on sexual behavior (time frame: prospective). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00601276, which also lists 1 linked publication.
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 Oct 2026.