Peyronie's Disease Treatment Protocol

NCT02072018 | Completed Phase 1 DMC

• 1 other identifier: PDTP1
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peyronie's Disease

Keywords

Peyronie's; Peyronie's disease; Treatment; Clinical Study

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to six months

Secondary Outcomes (1)

• Efficacy measure

  Up to three and six months (the Placebo group will change from Placebo to H-100 at the end of three months)

Study Arms (2)

H-100

ACTIVE COMPARATOR

H-100, gel, daily, 6 months

Drug: H-100

Placebo

PLACEBO COMPARATOR

Placebo gel, daily, three months then switch to H-100 for three months

Drug: H-100; Drug: Placebo

Interventions

H-100 DRUG

H-100 is a new compound to be applied to Peyronie's disease tissue with the intention of reducing disease symptoms.

H-100; Placebo

Placebo DRUG

Placebo is an established, standard compound to be applied to Peyronie's disease tissue that will have no effect on disease symptoms.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hybrid Medical: lead

Study Sites (1)

North Memorial Medical Center

Robbinsdale, Minnesota, 55422, United States

Location

MeSH Terms

Conditions

Penile Induration

Interventions

complement H100

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jeffry Twidwell, MD

  North Memorial Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2013
• First Posted: February 26, 2014
• Study Start: June 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 26, 2014

Record last verified: 2014-02

Locations

US (1)