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Clinical Trials

Midtown Urology Division of Medical Research

Clinical Research Director
Jenileigh Obsorn
Ext. 117
josborn@midtown-urology.com



Ongoing Research Studies:

  • A phase III, randomized, double-blind, placebo-controlled, safety and efficacy trial of flibanserin in premenopausal women with hypoactive sexual desire disorder in North America
    Ongoing since July 2006
    Sponsors: Boehringer Ingelheim Pharmaceuticals, Inc.
    Website: www.decreasedsexualdesire.com


  • A phase III, randomized, double-blind, placebo controlled, multi-center efficacy and safety study of toremifene citrate for prevention of prostate cancer in men with High Grade PIN (prostatic intraepithelial neoplasia)
    Ongoing since January 2005
    Sponsors: GTx The Men’s Biotech Company


  • A phase III, prospective, open label study to evaluate the ability of MUSE (intraurethral alprostadil) to decrease erectile function recovery time after bilateral nerve- sparing radical prostatectomy
    Ongoing since September 2005
    Sponsors: Vivus, Inc.


  • A phase III, double-blind, placebo-controlled study evaluating the effect of selenium and vitamin E alone and in combination on clinical evidence of prostate cancer
    Ongoing since October 2002
    Sponsors: National Cancer Institute and the Southwest Oncology Group


  • A multicenter, prospective, randomized, masked, two-armed study to evaluate the safety and effectiveness of the AttenueX Intravesical System in the management of females with stress urinary incontinence
    Ongoing since May 2006
    Sponsors: Solace Therapeutics, Inc.
    Website: www.bladdercomfort.com


  • A multicenter, phase II, open- labeled study to assess the effects, safety, and quality of life associated with VTP (vascular, targeted photodynamic) therapy in low- risk, localized prostate cancer patients
    Anticipated start date: September 2007
    Sponsors: Steba Biotech

 



Past Research Studies

  • A Randomized, Double-Blind, Placebo Controlled, Multicenter Efficacy and Safety Study of Toremifene Citrate for the Prevention of Bone Fractures in Men with Prostate Cancer on Androgen Deprivation Therapy
    Ongoing since June 2005
    Sponsors: GTx The Men's Biotech Company

  • A Randomized, Double-Blind, Placebo Controlled, Multicenter Efficacy and Safety Study of Toremifene Citrate for the Prevention of Bone Fractures in Men with High Grade Prostatic Intraepithelial Neoplasia
    Ongoing since February 2005
    Sponsors: GTx The Men's Biotech Company

  • A Double-Blind, Randomized, 6-Month Evaluation of the Safety and Efficacy of Topical Alprostadil in Hysterectomized Women with Female Sexual Arousal Disorder (FSAD)
    Ongoing since February 2005
    Sponsors: Vivus, Inc.

  • Attitudes of African Americans Toward Genetic Testing for Prostate Cancer Risk
    Ongoing since August 2003
    Sponsors: National Institutes of Health (NIH) and National Institute of General Medical Sciences (NIGMS)

  • Female Sexual Disorder (FSD) Study
    Ongoing since January 2003
    Sponsor: Independent Study

  • A Double-Blind, Placebo-Controlled Study of the Effect of Zoledronic Acid on Bone Mineral Density in Men Receiving Androgen-Deprivation Therapy for Prostate Cancer
    Ongoing since May 2003
    Sponsors: Novartis Pharmaceutical Corp. and The University of Chicago

  • Attitudes of African Americans Toward Genetic Testing for Prostate Cancer Risk
    Ongoing since August 2003
    Sponsors: National Institutes of Health (NIH) and National Institute of General Medical Sciences (NIGMS)

  • A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5mg Administered Orally Once daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer
    Ongoing since August 2003
    Sponsors: GlaxoSmithKline  
  • The Role of Alpha-Blockade in the management of LUTS in Women
    Length of study: 11/03-4/04
    Sponsor: Boehringer-Ingelheim

  • High Grade Prostate Intraepithelial Neoplasia (PIN) Study
    Length of study: 5/02-4/04
    Sponsor: GTx, Inc.

  • The African American Hereditary Prostate Cancer Study
    Length of study: 3/98-3/04
    Sponsors: National Institutes of Health and Howard University
  • Validation Study of the Abbott Urinary Symptom Questionnaire (AUSQ) for Urinary Incontinence and the Overactive Bladder
    Length of study: 05/01-07/01
    Sponsor: Abbott Laboratories
  • An Open-label Comparison of Neoadjuvant Hormonal Therapy (NHT) With Abarelix Depot 100 mg IM or Lupron Depot®® 7.5 mg IM in Patients With Prostate Cancer Planned to Undergo Brachytherapy or External-beam Radiation Therapy
    Length of study: 06/01-10/01
    Sponsor: Amgen

  • A Patient Acceptability Study of a Once-Daily Formulation of Tolterodine. A Phase IIIB, Open-Label, Single-Arm Trial in Adult Patients with Overactive Bladder and Symptoms of Urinary Frequency, Urgency, and/or Urge Incontinence
    Length of study: 11/00-06/01
    Sponsor: Pharmacia & Upjohn
  • Detrol in the Community (DECO) Study
    Length of study: 08/00-03/01
    Sponsor: Innovative Health Solutions
  • A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Fixed-Dose, Parallel Group, 6-Month Comparison Study To Investigate The Efficacy And Safety Of The Phosphodiesterase Type V Inhibitor BAY 38-9456 In Males With Erectile Dysfunction
    Length of study: 6/00-4/01
    Sponsor: Bayer Corporation
  • The Effect of Neoadjuvant Hormonal Therapy Prior to Brachytherapy in the Treatment of Localized Prostate Cancer in African American Men
    Length of study: 7/00-2/01
    Sponsor: Integrated Therapeutics Group, Inc., a subsidiary of Schering-Plough
  • An Open Label Study to Evaluate Patient Acceptance and Safety of OROS Oxybutynin Chloride in Urge Urinary Incontinence
    Sponsor: ALZA
  • A Multicenter Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess the Effect of 100mg ZD6169 Once Daily in Subjects with Idiopathic Detrusor Instability
    Sponsor: Zeneca Pharmaceuticals
  • An Open-label, Multi-center, Single-arm Study to Investigate the Safety, Tolerability and Efficacy of Flexible Doses of Vardenafil Given on Demand in African American, Hispanic and Caucasian Males with Erectile Dysfunction
    Sponsor: Bayer Corporation
  • Efficacy of Tolterodine ER vs. Placebo for the Symptom of Urgency and the Improvement in Bladder Condition
    Length of study: 10/02-2/03
    Sponsor: Pharmacia, Inc.

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