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Status:

COMPLETED

Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy

Lead Sponsor:

Johns Hopkins University

Conditions:

Prostate Cancer

Erectile Dysfunction

Eligibility:

MALE

40-65 years

Phase:

PHASE2

Brief Summary

This research study aims to explore the effectiveness of human erythropoietin versus placebo in promoting the recovery of erectile function in patients undergoing bilateral nerve-sparing radical retro...

Detailed Description

This study will evaluate the effectiveness of erythropoietin versus placebo in the recovery of erectile function in patients undergoing bilateral nerve-sparing radical prostatectomy for prostate cance...

Eligibility Criteria

Inclusion

  • Patient eligibility consists of men 40 to 65 years of age
  • Localized prostate cancer
  • clinical stage T2a or lower
  • Gleason grade of 3+4 or 3+3
  • prostate specific antigen (PSA) \< 10
  • Scheduled to undergo curative prostatectomy applying bilateral nerve-sparing procedure, with intact pre-surgical erectile function
  • International Index of Erectile Function-5 (IIEF-5) score of 22-25.
  • The patient has a sexual partner, of at least 6 months.
  • The patient's pre-surgical hematocrit is ≤ 48.
  • The patient is willing to attempt intercourse at least 5 times per month following recovery from surgery.

Exclusion

  • The patient has known penile deformity or a history of Peyronie's disease.
  • The patient has planned pre or post operative androgen therapy.
  • The patient has planned pre or post operative radiation therapy.
  • The patient is on anticoagulation therapy.
  • The patient has a history of sickle cell anemia.
  • The patient has a history of high or low blood pressure that is not controlled.
  • The patient is taking medications called "nitrates"
  • The patient has a history of heart problems such as angina, heart failure, irregular heartbeats, or myocardial infarction
  • The patient has a history of history of drug or alcohol abuse.
  • The patient currently smokes or has a 20 pack/year history of cigarette smoking.
  • The patient has a history of acute or chronic depression
  • The patient has a history liver problems, or kidney problems.
  • The patient has a history of retinitis pigmentosa or severe vision loss, including a condition called NAION, Nonarteritic Anterior Ischemic Optic Neuropathy.
  • The patient has a history of spinal trauma or surgery to the brain or spinal cord.
  • The patient has contraindications to the use of phosphodiesterase type 5 (PDE 5) inhibitors.
  • Patient is currently participating in another clinical investigation that would serve as a contraindication to administering erythropoietin.

Key Trial Info

Start Date :

July 1 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 31 2019

Estimated Enrollment :

56 Patients enrolled

Trial Details

Trial ID

NCT00737893

Start Date

July 1 2017

End Date

December 31 2019

Last Update

April 8 2021

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287