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Therapeutic Areas: Nephrology/Urology
Disease Category: Erectile Dysfunction

Trial Information

Erectile Dysfunction Study

A Randomized, placebo-controlled, double-blind, parallel design, phase 3 study to assess the safety and efficacy of XXXXXXX tablets in male subjects with erectile dysfunction.

4 arms: 0mg, 50mg, 100mg and 150mg.

Inclusion

• must be over age 19 with a female partner (who also has to sign the ICF)
• min. of 3 month ED history
• an IIEF score between 6 and 25
• diabetes is ok

Exclusion

• previously failed to respond to PDE-5 inhibitors
• new onset (within 3 months) of CAD, MI, stroke or cardiac surgical (within 6 months)
• symptomatic CHF
• taking nitrates
• other ED meds within 14 days
• testosterone replacement therapy less than 3 month (longer, stable does is ok)
• hx of:
  • proliferative diabetic retinopathy
  • retinitis pigmentosa
  • spinal cord injury or trauma
  • penile anatomical deformity
  • hematological disorder (i.e. peptic ulceration)
  • sickle cell
  • multiple myeloma
  • leukemia
  • significant psychiatric disorder
  • recent drug abuse
  • hypoactive sexual desire
  • premature ejaculation
• Con meds:
  • Erythromycin
  • Intraconazole, ketoconazole
  • Ritonavir, saquinavir, amprenavir, indinavir, nelfinavir
  • Cimetidine
  • Anticoagulants
  • Trazodone

AdvanceMed Research
2 Princess Rd., Suite J
Lawrenceville, NJ 8648
Phone: (609) 895-0735

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