We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Lupron Sex Offender Therapy

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.
ClinicalTrials.gov Identifier: NCT00220350
Recruitment Status : Unknown
Verified September 2005 by Schober, Justine, M.D..
Recruitment status was:  Active, not recruiting
First Posted : September 22, 2005
Last Update Posted : September 22, 2005
Sponsor:
Collaborator:
TAP Pharmaceutical Products Inc.
Information provided by:
Schober, Justine, M.D.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pedophilia Drug: leuprolide acetate Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Leuprolide Acetate Suppresses Pedophilic Urges and Arousability
Study Start Date : October 2001
Estimated Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. suppressed arousal

Secondary Outcome Measures :
  1. safety


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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:pedohilia admission,healthy,male,adult,ability to have penile response on plethysmography -

Exclusion Criteria:Denial of pedophilia, seizure disorder treated with dilantin or barbiturates, alcoholism, IQ less than 70


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 ClinicalTrials.gov identifier (NCT number): NCT00220350


Locations
United States, Pennsylvania
Hamot Medical Center
Erie, Pennsylvania, United States, 16507
Sponsors and Collaborators
Schober, Justine, M.D.
TAP Pharmaceutical Products Inc.
Investigators
Principal Investigator: Justine M Schober, MD Hamot Medical Center

ClinicalTrials.gov Identifier: NCT00220350     History of Changes
Other Study ID Numbers: Lupron trial
TAP Pharmaceuticals
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 22, 2005
Last Verified: September 2005

Keywords provided by Schober, Justine, M.D.:
arousal
sex offender
suppression of arousal
pedohilia
leuprolide acetate

Additional relevant MeSH terms:
Pedophilia
Paraphilic Disorders
Mental Disorders
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents