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Xiaflex® Plus Testosterone Treatment Pilot Study Protocol

Primary Purpose

Peyronie's Disease (PD)

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Xiaflex®

Aveed

About this trial

This is an interventional treatment trial for Peyronie's Disease (PD) focused on measuring Peyronie's disease, Hypogonadism

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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
Willing to be followed at MHB for the next 3 months
Willing to provide informed consent for this study

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)
Previous exposure to exogenous T, clomiphene citrate, or other Selective Estrogen Receptor Modulators, unless off therapy for at least 12 weeks
Presence of dense calcified plaque by ultrasound at screening
Hypersensitivity to testosterone, stearic acid, or polyvinylpyrolidone (the constituents of Aveed®)
Unwillingness to start testosterone therapy
Screening total testosterone of greater than 350 ng/dL
Screening free testosterone of more than 1.5ng/dL (analog assay) or 100pg/mL (calculated)
Unable to achieve adequate erection with penile injection to assess degree of curvature
Prior history of definitive treatment for prostate cancer, bladder cancer, or other pelvic malignancies including surgery, external beam radiation therapy, brachytherapy, cryotherapy
Prior history of prostate cancer, hematologic disorders, chronic liver disease including cirrhosis and hepatitis C, disorders affecting the immune system, including infection with human immunodeficiency virus, or psychiatric disorders including major depression, schizophrenia, bipolar disease
Prior history of cerebrovascular accident, history of deep venous thrombosis within the past 5 years or history of untreated or severe sleep apnea
Screening PSA more than 4.0 ng/mL, unless prostate cancer has been excluded to the Investigator's satisfaction
Incapable of giving informed consent or complying with the protocol

Sites / Locations

Men's Health Boston

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PD treatment with Xiaflex® plus Aveed

Arm Description

Peyronie's Disease treatment with Xiaflex® and Aveed®. All 20 subjects will be treated with Xiaflex® and Aveed®. The data collected from this pilot project will be analyzed and compared to historical data regarding treatment for PD with Xiaflex® alone.

Outcomes

Primary Outcome Measures

change in penile curvature

The primary objective of this study is to determine whether supplemental testosterone treatment offers change in efficacy to Xiaflex® (collagenase clostridium histolyticum) alone in selected men undergoing treatment for Peyronie's disease. The primary endpoints are change in degrees of penile curvature from baseline.

change in PDQ responses

change in global sexual satisfaction, as measured by the Peyronie's Disease Questionnaire (PDQ). Not a scale but direct comparison of patients sexual activity through patients' answers.

Secondary Outcome Measures

Change in plaque size

(mm longest diameter)

Change in quality of life

(Patient Health Questionnaire) Scale total can range from 0 to 27 (Not difficult at all to very difficult) Higher values would be worse outcome

Quality of erections and satisfaction with sexual function

(International Index of Erectile Function) No scale, direct comparison of answers

Change in quality of life

(Low T Questionnaire) Scale total ranges from 0 to 84 (strongly agree to strongly disagree) Higher values would be worse outcome

Full Information

NCT ID

NCT03815331

First Posted

January 14, 2019

Last Updated

December 30, 2020

Sponsor

Men's Health Boston

1. Study Identification

Unique Protocol Identification Number

NCT03815331

Brief Title

Xiaflex® Plus Testosterone Treatment Pilot Study Protocol

Official Title

Xiaflex® Plus Testosterone Treatment Pilot Study Protocol A Six-month, Pilot Project of Testosterone Treatment in Subjects Who Are Undergoing Xiaflex® Therapy for the Treatment of Peyronie's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

January 14, 2019 (Actual)

Primary Completion Date

December 29, 2020 (Actual)

Study Completion Date

December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Men's Health Boston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

During this single-center pilot study, there will be one subject group consisting of men with Peyronie's disease and testosterone deficiency. Subject age range will be 18-70 years. Each subject will participate for approximately 6 months. All 20 subjects will receive Xiaflex® plus T treatment (Aveed®). Data collected from this pilot project will be analyzed and compared to historical data regarding treatment for PD using Xiaflex® only. The eligibility criterion for 2 samples of total testosterone (<350ng/dL) or free testosterone (1.5 ng/dL analog assay or 100pg/mL calculated free testosterone) was chosen with the aim of demonstrating what the effect of testosterone treatment is on men that fall into the low range. The remainder of the inclusion and exclusion criteria are designed to select subjects for whom protocol treatment is considered appropriate. All relevant medical and non-medical conditions will be taken into consideration when deciding whether this protocol is suitable for a particular subject.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peyronie's Disease (PD)

Keywords

Peyronie's disease, Hypogonadism

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Model Description

All 20 subjects will receive Xiaflex® plus T treatment (Aveed®). Data collected from this pilot project will be analyzed and compared to historical data regarding treatment for PD using Xiaflex® only.

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PD treatment with Xiaflex® plus Aveed

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Xiaflex®

Intervention Description

medication indicated for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. Xiaflex belongs to a family of enzymes called collagenases. Collagenases are proteinases that hydrolyze collagen in its native triple helical conformation under physiological conditions, resulting in lysis of collagen deposits. The signs and symptoms of Peyronie's disease are caused by a collagen plaque. Injection of XIAFLEX into a Peyronie's plaque, which is comprised mostly of collagen, may result in enzymatic disruption of the plaque. Following this disruption of the plaque, penile curvature deformity and patient bother caused by Peyronie's disease are reduced

Intervention Type

Drug

Intervention Name(s)

Aveed

Intervention Description

Aveed® is an FDA-approved medication for treatment of hypogonadism (low testosterone). It is not approved for the treatment of Peyronie's Disease. Aveed® 750 mg/3mL injection will be placed intramuscularly at the beginning of study, at four weeks, at 10 weeks thereafter.

Primary Outcome Measure Information:

Title

change in penile curvature

Description

Time Frame

6 months

Title

change in PDQ responses

Description

change in global sexual satisfaction, as measured by the Peyronie's Disease Questionnaire (PDQ). Not a scale but direct comparison of patients sexual activity through patients' answers.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Change in plaque size

Description

(mm longest diameter)

Time Frame

6 months

Title

Change in quality of life

Description

(Patient Health Questionnaire) Scale total can range from 0 to 27 (Not difficult at all to very difficult) Higher values would be worse outcome

Time Frame

6 months

Title

Quality of erections and satisfaction with sexual function

Description

(International Index of Erectile Function) No scale, direct comparison of answers

Time Frame

6 months

Title

Change in quality of life

Description

(Low T Questionnaire) Scale total ranges from 0 to 84 (strongly agree to strongly disagree) Higher values would be worse outcome

Time Frame

6 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 Willing to be followed at MHB for the next 3 months Willing to provide informed consent for this study 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) Previous exposure to exogenous T, clomiphene citrate, or other Selective Estrogen Receptor Modulators, unless off therapy for at least 12 weeks Presence of dense calcified plaque by ultrasound at screening Hypersensitivity to testosterone, stearic acid, or polyvinylpyrolidone (the constituents of Aveed®) Unwillingness to start testosterone therapy Screening total testosterone of greater than 350 ng/dL Screening free testosterone of more than 1.5ng/dL (analog assay) or 100pg/mL (calculated) Unable to achieve adequate erection with penile injection to assess degree of curvature Prior history of definitive treatment for prostate cancer, bladder cancer, or other pelvic malignancies including surgery, external beam radiation therapy, brachytherapy, cryotherapy Prior history of prostate cancer, hematologic disorders, chronic liver disease including cirrhosis and hepatitis C, disorders affecting the immune system, including infection with human immunodeficiency virus, or psychiatric disorders including major depression, schizophrenia, bipolar disease Prior history of cerebrovascular accident, history of deep venous thrombosis within the past 5 years or history of untreated or severe sleep apnea Screening PSA more than 4.0 ng/mL, unless prostate cancer has been excluded to the Investigator's satisfaction Incapable of giving informed consent or complying with the protocol

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Abraham Morgentaler, MD

Organizational Affiliation

Men's Health Boston

Official's Role

Principal Investigator

Facility Information:

Facility Name

Men's Health Boston

City

Chestnut Hill

State/Province

Massachusetts

ZIP/Postal Code

02467

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

8976279

Citation

Brock G, Hsu GL, Nunes L, von Heyden B, Lue TF. The anatomy of the tunica albuginea in the normal penis and Peyronie's disease. J Urol. 1997 Jan;157(1):276-81.

Results Reference

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PubMed Identifier

19473459

Citation

Moreno SA, Morgentaler A. Testosterone deficiency and Peyronie's disease: pilot data suggesting a significant relationship. J Sex Med. 2009 Jun;6(6):1729-1735. doi: 10.1111/j.1743-6109.2009.01250.x. Epub 2009 Mar 30.

Results Reference

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PubMed Identifier

12454687

Citation

Gonzalez-Cadavid NF, Magee TR, Ferrini M, Qian A, Vernet D, Rajfer J. Gene expression in Peyronie's disease. Int J Impot Res. 2002 Oct;14(5):361-74. doi: 10.1038/sj.ijir.3900873.

Results Reference

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PubMed Identifier

8976281

Citation

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PubMed Identifier

12647000

Citation

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Citation

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PubMed Identifier

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Citation

Hetzler LE, Sharma N, Tanzer L, Wurster RD, Leonetti J, Marzo SJ, Jones KJ, Foecking EM. Accelerating functional recovery after rat facial nerve injury: Effects of gonadal steroids and electrical stimulation. Otolaryngol Head Neck Surg. 2008 Jul;139(1):62-7. doi: 10.1016/j.otohns.2008.02.006.

Results Reference

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PubMed Identifier

18324583

Citation

Maus U, Andereya S, Schmidt H, Zombory G, Gravius S, Ohnsorge JA, Niedhart C. [Therapy effects of testosterone on the recovery of bone defects]. Z Orthop Unfall. 2008 Jan-Feb;146(1):59-63. doi: 10.1055/s-2007-989436. German.

Results Reference

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PubMed Identifier

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Citation

Cavallini G, Biagiotti G, Lo Giudice C. Association between Peyronie disease and low serum testosterone levels: detection and therapeutic considerations. J Androl. 2012 May-Jun;33(3):381-8. doi: 10.2164/jandrol.111.012948. Epub 2011 Jun 30.

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Citation

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Citation

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Results Reference

result

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Xiaflex® Plus Testosterone Treatment Pilot Study Protocol

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