Xiaflex® Plus Testosterone Treatment Pilot Study Protocol (NCT03815331) | Clinical Trial Compass
CompletedPhase 4
Xiaflex® Plus Testosterone Treatment Pilot Study Protocol
United States20 participantsStarted 2019-01-14
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexMALE
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Inclusion criteria
✓. Ability to read, write, and understand English
✓. Age greater than or equal to 18
✓. Age less than or equal to 70
✓. Identification of acquired penile curvature of greater than 30 degrees and less than 90 degrees associated with palpable penile plaque on physical examination at screening
✓. Screening total testosterone of less than 350 ng/dL, twice withine 30 days of treatment
✓. Screening free testosterone of less than 1.5ng/dL (analog assay) or 100pg/mL (calculated)
✓. Planning to initiate Xiaflex® injections at MHB
✓. Willingness to initiate testosterone therapy
Exclusion criteria
✕. Prior history of treatment for PD that includes surgery
✕. Prior treatment with oral therapy for PD unless at least stopped 2 weeks prior to signing the informed consent (e.g. Potaba, Vitamin E, colchicines)