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Evaluate the Effects of GPI 1485 on Erectile Function Following Bilateral Nerve-sparing Prostatectomy
This study is currently recruiting patients.
Sponsored by: | Guilford Pharmaceuticals
Symphony Neuro Development Company
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Information provided by: | Guilford Pharmaceuticals |
Purpose
In this phase II study, an investigative (not approved by the FDA) drug called GPI 1485 is being assessed to see if it can help preserve erectile function after prostatectomy. This drug has been tested in animals, and was shown to protect nerves from damage and to regrow damaged nerves in these animal studies. Participants will receive either GPI 1485 or a placebo (inactive pill). Participants will begin study medication 3 full days prior to their scheduled surgery.
GPI 1485 will be supplied as an oral tablet formulation to men who are candidates for bilateral nerve-sparing prostatectomies. Participants randomly assigned to receive GPI 1485 will be required to take four tablets four times a day by mouth.
GPI 1485 matching placebo will also be supplied as an oral tablet formulation. Participants randomly assigned to placebo will be required to take 4 placebo tablets four times a day by mouth.
Viagra® will be supplied as oral tablets beginning 1 month post-surgery. Patients can begin Viagra® 1 month post-surgery and may continue use until the end of the study, as needed.
The duration of this study is 12 months which includes 5 office visits to your doctor in addition to the surgery day. During this study you will also have other clinical evaluations including a physical exam, blood work, ECG (tracing of your heart rhythm) and urinalysis.
Participants enrolled in this study will also carry a handheld diary that is loaded with special protocol-specific software, which will be referred to as the patient experience diary (PED). Over the duration of this study, participants will complete their questionnaires and answer questions about their medication compliance in the electronic PED.
Condition | Treatment or Intervention | Phase |
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Impotence Prostate Cancer |
Drug: GPI 1485 |
Phase II |
MedlinePlus related topics: Erectile Dysfunction; Prostate Cancer
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 3 Arm, 12-Month Study to Evaluate the Effects of GPI 1485 on Erectile Function in Patients Undergoing Bilateral Nerve-Sparing Radical Retropubic Prostatectomy for Prostatic Carcinoma
Expected Total Enrollment: 240
Study start: December 2003
Eligibility
Ages Eligible for Study: 40 Years - 69 Years, Genders Eligible for Study: Male
Criteria
Inclusion Criteria:
Exclusion Criteria:
Location and Contact Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
Copyright, Privacy, Accessibility, Freedom of Information Act |