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Lupron Sex Offender Therapy
Plain-language guide to NCT00220350: phase 2, phase 3 non-randomized trial of Leuprolide, 10 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00220350
- Phase
- phase 2, phase 3
- Status
- status unknown
- Start
- 2001-10
- Completion (planned or actual)
- 2005-08
- Participants
- 10
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Pedophilia
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2, phase 3) is built around Leuprolide.
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.
The registry classes the interventions as drug.
More on the Plan
Hormone therapy is aimed at modification of the basic sex drive, whereas cognitive-behavioral psychotherapy targets cognitive processes that precede all events leading to pedophilic behavior.
Obsession/compulsion and sex drive might affect the decision process.
Most reports have been documented from individual case studies or uncontrolled, retrospective studies (Kafka, 2000).
The anti-androgens, MPA and CPA, are the most widely used drugs.
Who Took Part
The registry lists 10 planned participants were the target.
It was open to men only aged from 18 years with no upper age limit.
Healthy volunteers could join, not only people with the condition.
How the Study Was Run
The set-up was non-randomized, single-group and open-label.
Everyone knew when Leuprolide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2001-10 with completion listed for 2005-08.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: suppressed arousal.
It also tracked 1 secondary outcome, for example safety.
What This Means in Plain Language
Put simply, this is a phase 2, phase 3, non-randomized trial of Leuprolide in 10 people.
Its size is small, so on its own it can only give an early look.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Leuprolide compound page, all human trials.
Our Notes on the Compound
Leuprolide: A 9-amino-acid GnRH analog (Lupron, Eligard) that lowers sex-hormone levels with ongoing use; used in prostate cancer, endometriosis and early puberty.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.