Deliverable: Transcripts

Objectives:

n      Compare and contrast current treatment options for testosterone replacement therapy (TRT)

n      Elicit expert feedback on testosterone undecanoate (Indevus’s Nebido)

n      Clarify potential utilization of testosterone undecanoate

Products Highlighted:

n      Nebido® (testosterone undecanoate), Indevus

n      Testim® (testosterone gel), Auxilium

n      Striant® (testosterone buccal system), Columbia Laboratories

n      Testoderm® (testosterone trandermal patch), Alza, Johnson & Johnson

n      Androderm® (testosterone trandermal patch), Watson Pharmaceuticals

Topics:

n      Current TRT treatment practices

n      Drivers of therapy/formulation selection

n      Strengths and weaknesses of existing agents

n      Unmet needs

n      Impressions of Nebido efficacy and safety data

n      Potential competitors

n      Future role of selective androgen receptor modulators (SARMs) in TRT

Selected Quotes:

n      In choosing a treatment, variabless that I consider include cost, consistency of treatment, tolerability of treatment, efficacy of treatment and side effects of the various treatment options

n      Where cost of the preparation is a primary factor, I first suggest …

n      It's an issue for about 30-40% of my patients

n      Seeking a well tolerated, affordable option with consistent dosing, and dose flexibility. None of the current options meet all of these needs.

n      Depends on dosing freq and stability of T levels between doses. Also depends on how great the rise in Hct will be.

Screening Criteria:

n      Board-certified in urology; endocrinology

n      2-30 years of practice

n      Significant experience treating hypogonadism with testosterone replacement therapy

n      Publication history in hypogonadism

n      Clinical trial experience in this domain

Representative Institutions:

n      Beth Israel Deaconess Medical Center

n      Brigham and Women’s Hospital

n      Duke University Medical Center

n      UCLA

n      University Hospitals of Cleveland

n      Tulane University