Peyronie's Disease (PD)Phase 4NCT03815331
Xiaflex® Plus Testosterone Treatment Pilot Study Protocol
A Phase 4 study testing Xiaflex® and Aveed in people with Peyronie's Disease (PD), run by Men's Health Boston at 1 site in United States.
Trial 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®). Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Peyronie's Disease (PD)
- What is being tested?
- Xiaflex® and Aveed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2019to 30 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Men's Health Boston
Chestnut Hill, Massachusetts, 02467
About this study
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
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.
Read the 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.
- Conditions
- Peyronie's Disease (PD)
- Being tested
- Xiaflex®, Aveed
- Keywords
- Peyronie's disease, Hypogonadism
- Medical subject headings
- Penile Induration, Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xiaflex®Drug
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
AveedDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| PD treatment with Xiaflex® plus Aveed | Experimental | 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. Receives: Drug: Xiaflex®; Drug: Aveed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
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.
Measured: 6 months
Secondary outcomes (4)
Change in plaque size
(mm longest diameter)
Measured: 6 months
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
Measured: 6 months
Quality of erections and satisfaction with sexual function
(International Index of Erectile Function) No scale, direct comparison of answers
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start14 Jan 2019
- Primary completion29 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Peyronie's Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Men's Health Boston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Abraham Morgentaler, Men's Health Boston
- Investigators
- Abraham Morgentaler, MD, Principal investigator, Men's Health Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815331
- Sponsor's protocol ID
- MHB024
- Status last verified
- Dec 2020
- First submitted
- 14 Jan 2019
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 8976279Moreno 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.
PubMed 19473459Gonzalez-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.
PubMed 12454687Devine CJ Jr, Somers KD, Jordan SG, Schlossberg SM. Proposal: trauma as the cause of the Peyronie's lesion. J Urol. 1997 Jan;157(1):285-90. doi: 10.1016/s0022-5347(01)65361-8.
PubMed 8976281Shen ZJ, Zhou XL, Lu YL, Chen ZD. Effect of androgen deprivation on penile ultrastructure. Asian J Androl. 2003 Mar;5(1):33-6.
PubMed 12647000Demling RH. The role of anabolic hormones for wound healing in catabolic states. J Burns Wounds. 2005 Jan 17;4:e2.
PubMed 16921407Hetzler 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.
PubMed 18585563Maus 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.
PubMed 18324583Cavallini 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.
PubMed 21719695Stallard N. Optimal sample sizes for phase II clinical trials and pilot studies. Stat Med. 2012 May 20;31(11-12):1031-42. doi: 10.1002/sim.4357. Epub 2011 Nov 3.
PubMed 22052407Taylor FL, Levine LA. Peyronie's Disease. Urol Clin North Am. 2007 Nov;34(4):517-34, vi. doi: 10.1016/j.ucl.2007.08.017.
PubMed 17983892
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03815331
- Acronym / sponsor ID
- MHB024
- Conditions
- Peyronie's Disease (PD)
- Keywords
- Peyronie's disease, Hypogonadism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Men's Health BostonUniversity, hospital or other
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 29 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 24 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| PD treatment with Xiaflex® plus Aveed | Experimental | Drug: Xiaflex®, Drug: AveedPeyronie'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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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®)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xiaflex®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 | Drug | PD treatment with Xiaflex® plus Aveed |
| AveedAveed® 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. | Drug | PD treatment with Xiaflex® plus Aveed |
Primary outcome
change in penile curvature
Time frame: 6 months
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
Time frame: 6 months
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.
4 secondary outcomes
Change in plaque size
Time frame: 6 months
Change in quality of life
Time frame: 6 months
Quality of erections and satisfaction with sexual function
Time frame: 6 months
Change in quality of life
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Background: PubMed 8976279Brock 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.
- Background: PubMed 19473459Moreno 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.
- Background: PubMed 12454687Gonzalez-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.
- Background: PubMed 8976281Devine CJ Jr, Somers KD, Jordan SG, Schlossberg SM. Proposal: trauma as the cause of the Peyronie's lesion. J Urol. 1997 Jan;157(1):285-90. doi: 10.1016/s0022-5347(01)65361-8.
- Background: PubMed 12647000Shen ZJ, Zhou XL, Lu YL, Chen ZD. Effect of androgen deprivation on penile ultrastructure. Asian J Androl. 2003 Mar;5(1):33-6.
- Background: PubMed 16921407Demling RH. The role of anabolic hormones for wound healing in catabolic states. J Burns Wounds. 2005 Jan 17;4:e2.
- Background: PubMed 18585563Hetzler 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.
- Background: PubMed 18324583Maus 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.
- Background: PubMed 21719695Cavallini 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.
- Background: PubMed 22052407Stallard N. Optimal sample sizes for phase II clinical trials and pilot studies. Stat Med. 2012 May 20;31(11-12):1031-42. doi: 10.1002/sim.4357. Epub 2011 Nov 3.
- Results publication: PubMed 17983892Taylor FL, Levine LA. Peyronie's Disease. Urol Clin North Am. 2007 Nov;34(4):517-34, vi. doi: 10.1016/j.ucl.2007.08.017.
- Individual participant dataSharing planned: Undecided
Related trials for Peyronie's Disease (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abraham Morgentaler, MD principal investigator
Men's Health Boston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xiaflex® and Aveed in people with Peyronie's Disease (PD), run by Men's Health Boston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in penile curvature (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03815331, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2020.