Xiaflex® Plus Testosterone Treatment Pilot Study Protocol
Status:
Completed
Trial end date:
2020-12-30
Target enrollment:
Participant gender:
Summary
In this open-label, six-month, pilot study of men with Peyronie's disease there will be one
subject group consisting of 20 subjects. All subjects will receive Xiaflex® plus testosterone
(T) treatment (Aveed®). Males included in the study must be 18-70 years old; have a history
of PD for more than six months; and have at two serum total testosterone level less than 350
ng/dL within 30 days prior to enrollment. The primary objective of this pilot study is to
determine whether testosterone therapy offers increased efficacy of Xiaflex® (collagenase
clostridium histolyticum) in subjects undergoing treatment for Peyronie's disease.
Endpoints will include reduction in degree of curvature and response to the PDQ
questionnaire. Secondary objectives will be to assess men for change in plaque size, quality
of life parameters, and sexual function. Data collected from this pilot study will be
analyzed and compared to historical data regarding treatment for PD using Xiaflex® only. This
pilot study will establish preliminary evidence needed to continue more in-depth research
regarding Xiaflex® with T therapy and serve as a means to evaluate feasibility of a
full-scale study.