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NCT00812838 · ClinicalTrials.gov registry record · Phase 2
H-22411: BOTOX® for Peyronie's Disease
A Phase 2 study of Peyronie's Disease, sponsored by Mohit Khera.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT00812838: Completed Phase 2 study of Peyronie's Disease, sponsored by Mohit Khera.
NCT00812838 is a Phase 2 study of Peyronie's Disease that has completed, run by Mohit Khera. The registered enrollment target is 12 participants, below the 188-participant average among 5 other Peyronie's Disease trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00812838, a Phase 2 study of Peyronie's Disease, has completed, sponsored by Mohit Khera.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
Measured by a protractor from pictures taken at baseline (pre-treatment screening visit) and end of treatment at week 16 \*Crossover subjects were added to Experimental Group for analysis\* Negative value equates to a reduction in curvature Positive value equates to an increase in curvature
Conditions Studied
Interventions
- DRUG 100 units of Botulinum Toxin Type A
- OTHER Preservative free normal saline
- DRUG 100 units Botulinum Toxin A
Study Locations (1)
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2009-08-07 |
| Est. Completion | 2019-01-15 |
| Phase | Phase 2 |
What the finished NCT00812838 record still lists
NCT00812838 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 188-participant average among 5 other Peyronie's Disease trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Peyronie's Disease appearing as the primary indexed condition, and to 3 interventions - of which 100 units of Botulinum Toxin Type A is the first listed.
NCT00812838 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00812838 about?
NCT00812838 is a clinical study titled "H-22411: BOTOX® for Peyronie's Disease". 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 en...
What is the current status of trial NCT00812838?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2009-08-07. Estimated completion is 2019-01-15.
What conditions does trial NCT00812838 study?
This clinical trial studies the following conditions: Peyronie's Disease.
What interventions are being tested in trial NCT00812838?
The interventions under investigation include: 100 units of Botulinum Toxin Type A (DRUG), Preservative free normal saline (OTHER), 100 units Botulinum Toxin A (DRUG).
Who is sponsoring clinical trial NCT00812838?
This trial is sponsored by Mohit Khera, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00812838 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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