Severe pain during penile palpation (as determined by the investigator)
Allergy to collagenase or other medication required by the protocol
Average of 3 successive blood pressure readings of 160/100 mm Hg or greater during screening or the day 1 assessments
Any conditions affecting the penis, such as thrombosis of the dorsal penile artery or chordee in the presence or absence of hypospadias, or ED that was unresponsive
to phosphodiesterase type 5 inhibitors
Subjects who had received treatment or planned to undergo treatment for PD, including but not limited to any previous surgery, oral agents within 4 weeks,
intralesional medical therapies within 3 months, or use of mechanical devices within 2 weeks before the start of the study
Does not respond with full erection to prostaglandin E1 during malformation measurement
APPENDIX 2
PD-PRO Symptom Bother Domain Items
Items
Thinking about the last time you had an erection, how bothered were you by any pain or discomfort you may have felt in your erect penis?
Thinking about the last time you ejaculated, how bothered were you by any problem you may have had ejaculating?
Thinking about the last time you looked at your erect penis, how bothered were you by the way your penis looked?
Thinking of the last time you had or tried to have vaginal intercourse, how bothered were you by any physical problem you may have had?
How bothered are you with having vaginal intercourse less often?
Responses
1—Not at all bothered
2—A little bit bothered
3—Moderately bothered
4—Extremely bothered
Total potential score 0 to 20
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PHASE 2B STUDY OF COLLAGENASE CLOSTRIDIUM HISTOLYTICUM