CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
100 units of Botulinum Toxin Type A +2 moredrug
Likely dose
100 units of Botulinum Toxin Type Afrom record
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Search/NCT00812838
NCT00812838Phase 2Completed
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The Efficacy of Botulinum Toxin Type a in Treating Peyronie's Disease

Mohit Khera·interventional·Posted Dec 22, 2008·Updated Apr 8, 2024

In Brief

A Phase 2 clinical trial evaluating 100 units of Botulinum Toxin Type A, Preservative free normal saline, and 1 other intervention for Peyronie's Disease. Completed, enrolled 12 participants across 1 site.

Detailed Summary

Peyronie's disease is a condition in which a plaque, or hard lump, forms on the penis. It causes hardened tissue, pain, and an abnormal bending in the penis. These symptoms are more severe during an erection. Significant bending of the penis can result in pain, poor erections, and an inability to engage in sexual intercourse. This disease affects about 3% of the male population. The average age of onset of this disease is 57 years old. The cause of the disease is unknown. However, many believe that it may be due to trauma to the penis (such as injury or extremely vigorous sexual activity).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeyronie's Disease
CountriesUnited States
CollaboratorsAllergan

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 22, 2008
Enrollment StartAug 7, 2009
Primary CompletionFeb 15, 2017
Study CompletionJan 15, 2019
TodayJul 2, 2026
Enrollment to primary: 7.5 yearsPosted 17.5 years ago

Interventions

100 units of Botulinum Toxin Type Adrug

Approximately 20 to 30 injections of 100 units of BOTOX® given with a 20 gage needle directly into the penile plaque

Preservative free normal salineother

Approximately 20 to 30 injections of 10cc of preservative free normal saline given with a 20 gage needle directly into the penile plaque

100 units Botulinum Toxin Adrug

Approximately 20 to 30 injections of 100 units of BOTOX® given with a 20 gage needle directly into the penile plaque