Peyronie's DiseasePhase 1NCT02072018
Peyronie's Disease Treatment Protocol
A Phase 1 study testing H-100 in people with Peyronie's Disease, run by Hybrid Medical at 1 site in United States.
Trial summary
Treatment of Peyronie's disease remains difficult. The purpose of this study is to test the safety and efficacy of a new compound to treat this disease. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Peyronie's Disease
- What is being tested?
- H-100
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Dec 2013
- Phase
- Phase 1
- 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
- Have symptom(s) of Peyronie's disease (pain, curvature or plaque)
- Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile
- Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC). The subject must also sign an authorization form to allow disclosure of his protected health information (PHI). The PHI authorization form and informed consent form may be an integrated form or may be separate forms depending on the institution
- Be able to read, complete and understand the informed consent and various rating instruments in English
Who cannot join
- Inability to understand study goals and risks
- Inability to understand the informed consent
- Inability to achieve erection with or without PDE5 inhibitor use adequate for penetration if penile curvature is not a limiting factor
- Peyronie's disease symptoms greater than one year duration
- Chordee in the presence or absence of hypospadias Thrombosis of the dorsal penile artery or vein Infiltration by a benign or malignant mass resulting in penile curvature Infiltration by an infectious agent, such as lymphogranuloma venereum Ventral curvature from any cause Presence of an active sexually transmitted disease Known active hepatitis B or C Known immune deficiency disease or be positive for human immunodeficiency virus (HIV)
- Has previously undergone surgery for Peyronie's disease
Show all 21Show fewer
- Fails to have an erection which in the opinion of the investigator is sufficient to accurately measure the subject's penile deformity
- Has an isolated hourglass deformity of the penis (curvature caused by a plaque that is noncontiguous with the hourglass deformity may be treated)
- Has the plaque causing curvature of the penis located proximal to the base of the penis
- Has previously received alternative medical therapies for Peyronie's disease administered by the intralesional route (including, but not limited to, steroids, verapamil, and the naturally occurring low molecular weight protein, interferon-α2b) within 3 months before the first dose of study drug or plans to use any of these medical therapies at any time during the study
- Has received alternative medical therapies for Peyronie's disease administered by the oral (including, but not limited to, vitamin E [>500 U], potassium aminobenzoate [Potaba], tamoxifen, colchicine, pentoxifylline, over-the-counter erectile dysfunction medications, or steroidal anti-inflammatory drugs) or topical routes (including, but not limited to, verapamil applied as a cream) within 3 months before the first dose of study drug or plans to use any of these medical therapies at any time during the study
- Has had extracorporeal shock wave therapy (ESWT) for the correction of Peyronie's disease within the 6- month period before screening or plans to have ESWT at any time during the study
- Has used any mechanical type device for correction of Peyronie's disease within the 2-week period before screening or plans to use any these devices at any time during the study
- Has used a mechanical device to induce a passive erection within the 2-week period before screening or plans to use any of these devices at any time during the study
- Has significant erectile dysfunction that has failed to respond to oral treatment with phosphodiesterase type 5 (PDE5) inhibitors
- Has uncontrolled hypertension, as determined by the investigator
- Has a known recent history of stroke, bleeding, or other significant medical condition, which in the investigator's opinion would make the subject unsuitable for enrollment in the study
- Is unwilling or unable to cooperate with the requirements of the study including completion of all scheduled study visits
- Has received an investigational drug or treatment within 30 days before the first dose of study drug
- Has a known systemic allergy to any H-100 component
- Has received any collagenase treatments within 30 days of the first dose of study drug
Trial locations and contacts
1 site in 1 country.
United States1 site
North Memorial Medical Center
Robbinsdale, Minnesota, 55422
About this study
Official title: A Sequential, Randomized, Double-blind, Placebo-controlled, Prospective Study to Evaluate the Safety and Efficacy of the H-100 Treatment in Adult Male Volunteers With Peyronie's Disease
Treatment of Peyronie's disease remains difficult. The purpose of this study is to test the safety and efficacy of a new compound to treat this disease.
- Conditions
- Peyronie's Disease
- Being tested
- H-100, Placebo
- Keywords
- Peyronie's, Peyronie's disease, Treatment, Clinical Study
- Medical subject headings
- Penile Induration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H-100Drug
H-100 is a new compound to be applied to Peyronie's disease tissue with the intention of reducing disease symptoms.
PlaceboDrug
Placebo is an established, standard compound to be applied to Peyronie's disease tissue that will have no effect on disease symptoms.
| Study group | Role | What they receive |
|---|---|---|
| H-100 | Active comparator | H-100, gel, daily, 6 months Receives: Drug: H-100 |
| Placebo | Placebo comparator | Placebo gel, daily, three months then switch to H-100 for three months Receives: Drug: H-100; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measure
Number of participants with adverse events. Continuous monitoring for adverse events. An adverse event is the development of an undesirable medical condition - e.g. symptoms or abnormal results of an investigation - or the deterioration of a pre-existing medical condition (not relevant in this study). Per the subject description, adverse events will be reported as: mild, moderate or severe.
Measured: Up to six months
Secondary outcomes (1)
Efficacy measure
Measure for change in pain, curvature, length, plaque hardness and plaque size. At the end of three months the Placebo group will change from Placebo to H-100 for the remaining three months. The H-100 group will receive H-100 for six months.
Monitor for adverse events.
Measured: Up to three and six months (the Placebo group will change from Placebo to H-100 at the end of three months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startJun 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peyronie's DiseaseStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hybrid Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffry Twidwell, MD, Principal investigator, North Memorial Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072018
- Sponsor's protocol ID
- PDTP1
- Status last verified
- Feb 2014
- First submitted
- 9 Jul 2013
- Last updated
- 26 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sequential, Randomized, Double-blind, Placebo-controlled, Prospective Study to Evaluate the Safety and Efficacy of the H-100 Treatment in Adult Male Volunteers With Peyronie's Disease
- ClinicalTrials.gov ID
- NCT02072018
- Acronym / sponsor ID
- PDTP1
- Conditions
- Peyronie's Disease
- Keywords
- Peyronie's, Peyronie's disease, Treatment, Clinical Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hybrid MedicalIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Feb 2014 (estimated)
- 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.
Treatment of Peyronie's disease remains difficult. The purpose of this study is to test the safety and efficacy of a new compound to treat this disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| H-100 | Active comparator | Drug: H-100H-100, gel, daily, 6 months |
| Placebo | Placebo comparator | Drug: H-100, Drug: PlaceboPlacebo gel, daily, three months then switch to H-100 for three months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have symptom(s) of Peyronie's disease (pain, curvature or plaque)
- Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile
- Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC). The subject must also sign an authorization form to allow disclosure of his protected health information (PHI). The PHI authorization form and informed consent form may be an integrated form or may be separate forms depending on the institution
- Be able to read, complete and understand the informed consent and various rating instruments in English
Key exclusion criteria (21 listed)
- Inability to understand study goals and risks
- Inability to understand the informed consent
- Inability to achieve erection with or without PDE5 inhibitor use adequate for penetration if penile curvature is not a limiting factor
- Peyronie's disease symptoms greater than one year duration
- Chordee in the presence or absence of hypospadias Thrombosis of the dorsal penile artery or vein Infiltration by a benign or malignant mass resulting in penile curvature Infiltration by an infectious agent, such as lymphogranuloma venereum Ventral curvature from any cause Presence of an active sexually transmitted disease Known active hepatitis B or C Known immune deficiency disease or be positive for human immunodeficiency virus (HIV)
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 |
|---|---|---|
| H-100H-100 is a new compound to be applied to Peyronie's disease tissue with the intention of reducing disease symptoms. | Drug | H-100, Placebo |
| PlaceboPlacebo is an established, standard compound to be applied to Peyronie's disease tissue that will have no effect on disease symptoms. | Drug | Placebo |
Primary outcome
Safety measure
Time frame: Up to six months
Number of participants with adverse events. Continuous monitoring for adverse events. An adverse event is the development of an undesirable medical condition - e.g. symptoms or abnormal results of an investigation - or the deterioration of a pre-existing medical condition (not relevant in this study). Per the subject description, adverse events will be reported as: mild, moderate or severe.
1 secondary outcome
Efficacy measure
Time frame: Up to three and six months (the Placebo group will change from Placebo to H-100 at the end of three 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 26 Feb 2014.
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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.
Jeffry Twidwell, MD principal investigator
North Memorial Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing H-100 in people with Peyronie's Disease, run by Hybrid Medical 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 4 inclusion and 21 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 26 Feb 2014. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety measure (time frame: Up to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2014.