Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Not listed Phase 2Phase 3 Interventional Accepts healthy volunteers

Lupron Sex Offender Therapy

ClinicalTrials.gov ID: NCT00220350

Public ClinicalTrials.gov record NCT00220350. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 12, 2026, 11:25 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Leuprolide Acetate Suppresses Pedophilic Urges and Arousability

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study compared cognitive-behavioral psychotherapy with leuprolide acetate (LA) to cognitive-behavioral psychotherapy with saline injections for 12 months. Five white male pedophiles (M age, 50 years; range, 36-58) volunteered for a two-year study. LA was administered by Depo injection (7 mg initially, then 22.5 mg every 3 mos) for 12 months, followed by saline placebo. Effects of LA on testosterone levels, sexual interest preference by visual reaction time (Abel Assessment), penile tumescence (Monarch PPG), as well strong urges and masturbatory frequency to children (polygraph), were measured every three months. Subjects were treated with weekly cognitive-behavioral psychotherapy. On LA, testosterone decreased to castrate levels. Because of the suppression of testosterone, physiologic arousal response as measured by penile plethysmography (penile tumescence) was significantly suppressed compared with baseline. However, sufficient response remained to detect pedophilic interest. This pedophilic interest was also detected by visual reaction times. All subjects self-reported a decrease in strong pedophilic urges and masturbation. When asked about having pedophilic urges and masturbating to thoughts of children, polygraph responses indicated subjects were not deceptive when they reported decreases. On placebo, testosterone and physiologic arousal eventually rose to baseline levels. At baseline and on placebo, subjects were consistently deceptive regarding increased pedophilic urges and masturbatory frequency as noted by polygraph. Interest preference, as measured by Abel Assessment and Monarch PPG, was generally unchanged throughout the study. Cognitive-behavioral psychotherapy augmented with LA significantly reduced pedophilic fantasies, urges, and masturbation, but did not change pedophilic interest during one year of therapy. Deceptive responses by polygraph suggested that self-report was unreliable. Follow-up utilizing objective measures is essential for monitoring efficacy of treatment in pedophilia. Our study supports the supposition that modification of pedophilic behavior is possible. LA may augment cognitive-behavioral psychotherapy and help break the sequence leading to a reoffense.

Study identification

NCT ID
NCT00220350
Recruitment status
Not listed
Study type
Interventional
Phase
Phase 2, Phase 3
Lead sponsor
Schober, Justine, M.D.
Individual
Enrollment
10 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
Male
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2001
Primary completion
Not listed
Completion
Jul 31, 2005
Last update posted
Sep 21, 2005

2001 – 2005

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Hamot Medical Center Erie Pennsylvania 16507

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00220350, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 21, 2005 · Synced Sep 12, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00220350 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →