Research Studies

OUR IRB APPROVED RESEARCH PROTOCOLS:

1. The Effects Of Sperm Processing On Immune Infertility; Application to IVF and Male factor Infertility,PI: Bruce R. Gilbert, M.D.,Ph.D., David S.  Rosenfeld,M.D.  and George Cooper,Ph.D.,approved by the Research, Clinical Investigation and Publications Committee at North Shore University Hospital – February 1990-CLOSED

2. Ejaculation And Fertility Study In Spinal Cord Injured (SCI) And Non Spinal Cord (NSCI) Injured Men,PI: Bruce R. Gilbert, M.D.,Ph.D.,approved by the Research, Clinical Investigation and Publications Committee at North Shore University Hospital (93-017)- 8/20/1992-CLOSED

3. Human Sperm Zona Acceptor: Changes With Varicocele Ligation, PI: Bruce R. Gilbert, M.D.,Ph.D., awarded office based Urology Research Award July from the American Foundation for Urologic Disease- 1993 ,approved by the Research, Clinical Investigation and Publications Committee at North Shore University Hospital – July 1993 -CLOSED

4. Nutritional Supplementation Of Subfertile Men, PI: Bruce R. Gilbert, M.D.,Ph.D.,approved by the Research, Clinical Investigation and Publications Committee at North Shore University Hospital (98-037) :9/97 – 8/00-CLOSED

5. Sexual Dysfunction in women: Use of Alprostadil and Sildenafil in the evaluation and  treatment of female sexual dysfunction (99-123) June 27, 2000,PI: Bruce R. Gilbert, M.D.,Ph.D.,approved by the Research, Clinical Investigation and Publications Committee at North Shore University Hospital – CLOSED

6. Saline-Filled Testicular Prosthesis Adjunct Study  PI: Bruce R. Gilbert, M.D.,Ph.D., Sponsor: Mentor Corp. ,approved by the Research, Clinical Investigation and Publications Committee at North Shore University Hospital – (00-013) March 2, 2000, CLOSED

7. A Double-Blind, Placebo-Controlled, Parallel-Group Study to assess the Effect of pregabalin on reproductive Function in Healthy Male Subjects , Sponsor: Pfizer Inc.,PI: Bruce R. Gilbert, M.D.,Ph.D.,approved by the Research, Clinical Investigation and Publications Committee at North Shore University Hospital – July 2000 (00-105),- CLOSED

8. Silicone Elastomer Testicular Prosthesis Implant Study PI: Bruce R. Gilbert, M.D.,Ph.D.,PI: Bruce R. Gilbert, M.D.,Ph.D.,approved by the Research, Clinical Investigation and Publications Committee at North Shore University Hospital -(#00-205), July 10, 2001 CLOSED

9. Preservation of Germ Cells from Prepubescent Boys Prior to Gonadotoxic Therapy,PI: Bruce R. Gilbert, M.D.,Ph.D., approved by the Research, Clinical Investigation and Publications Committee at North Shore University Hospital – (#01-021) July 25, 2001 CLOSED

10. A Placebo-Controlled, Double Blind, Randomized, Parallel Study of the Efficacy and Safety of Dapoxetine HCL in the Treatment of Rapid Ejaculation. ALZA C-2002-013 CLOSED

11. An Open Label Study of the Long-Term Safety of Dapoxetine HCL in the Treatment of Rapid Ejaculation. ALZA C-2002-014-02 CLOSED

12. A Randomized, Double Blind, Dose Response Study to Evaluate the Safety and Clinical and Bacteriologic Efficacy of Rifalazil 2.5, 12.5, or 25 mg Compared with Azithromycin 1 g for the Treatment of Non-Gonococcal Uretritis (NGU) in Males.  ABI-1648-010 CLOSED

13. Study of Duloxetine HCL in Women of Different Demographic Characteristics and Co-morbidities with Stress Urinary IncontinenceL Evaluation of Efficacy and Safety. Eli Lilly F1J-US-SBCD CLOSED

14. A Randomised, double-blind, parallel group study to investigate the efficacy and safety of treatment with dutasteride (0.5mg) and tamsulosin (0.4mg), administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia.GSK ARI40005 CLOSED

15. A Randomised, double-blind, placebo controlled, parallel group study of the efficacy and safety of t dutasteride 0.5mg administered orally once daily for 4 years to reduce the risk of biopsy detectable prostate cancer..GSK ARI40006 CLOSED

16. Study of the Safety and Effectiveness of the Mentor Soft-Solid Testicular Prosthesis,Mentor U111-403-2 CLOSED

17. A randomized, double-blind, placebo controlled, parallel arm, multicenter trial assessing the effect of daily treatment of vardenafil 20 mg or sildenafil 100 mg compared to placebo on spermatogenesis, mean sperm concentration, sperm count, morphology, motility and reproductive hormones in healthy males or males with erectile dysfunction BAY 38-9456; Protocol # 11520 Bayer Pharmaceuticals CLOSED

18. Treatment of Pelvic Pain with Microcurrent Electrical Therapy (MET): A Placebo Controlled, double-blinded study, Bruce R. Gilbert, M.D., Ph.D., Robert Moldwin, M.D., (NS-LIJ IRB #05.02.132)-OPEN

19. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Spermatogenesis in Healthy Male Subjects During Administration of (BMS-562086 Protocol No, CN148014) CLOSED

20. A Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of Minocycline Extended-Release Tablets on Spermatogenesis in Human Males (Medicis Protocol No. MP-0104-18) CLOSED

21. Pivotal phase III trial to investigate the efficacy and safety of an Orodispersible Tablet vardenafil versus placebo in the treatment of men with Erectile dysfunction (ED) – a fixed-dose, double-blind, raNdomized multi-center Trial – POTENT II (BAY 38-9456/Protocol 12094) CLOSED

22. Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center, Efficacy and Safety Study of Imiquimod Creams in the Treatment of External Genital Warts (GW01-0801) CLOSED

23. A randomized, double-blind, placebo-controlled, parallel group, multicenter study of the safety and efficacy of avanafil in the treatment of erectile dysfunction following bilateral nerve-sparing radical prostatectom, Avanafil, Vivus TA-303, 2009 CLOSED

24. Prospective Case Crossover Study to Assess Whether PDE5 Inhibitor Exposure in Men with Erectile Dysfunction Increases the Risk for the Development of non-arteritic Anterior Ischemic Optic Neuropathy (NAION), Protocol #12912 , Bayer Healthcare 2010 OPEN

25. A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Effectiveness of AA4500 Administered twaice per Treatment Cycle for up to Four Treatment Cycles (2×4) in Men with Peyronie’s Disease, Protocol AUX-CC-804, 2010, Auxillium CLOSED

26. Effect of Udenafil on Spermatogenesis: A Double-blind, Randomized, Placebo-Controlled, Parallel-group Study, Protocol PR-00110.0 WC3043, Warner Chilcott, 2010 CLOSED

27. A Randomized, Double Blind, Placebo and Active Controlled, Parallel, Multi-Center Phase IIb Study to Evaluate Normalization of Morning Testosterone Levels in Men with Secondary Hypogonadism with Confirmed Morning Testosterone Levels <250ng/dL that Wish to Preserve Their Reproductive Status and are Not Currently being Treated with Topical Testosterone, Protocol #ZA-203, 2011, Repros CLOSED

28. A Randomized, Parallel, Double-Blind, Placebo-controlled Exploratory Study to Evaluate the Efficacy of Androxal in Improving Glycemic Control in Men with Secondary Hypogonadism (AIHH) and Type 2 Diabetes Mellitus with Sub-Optimum Treatment, Protocol #ZA-202, 2010, Repros CLOSED

29. Patient Reported Outcome Measure Development in the area of Hypogonadism , THG 1021 ELC, Eli Lilly, 2011

30. Phase III, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men, Protocol  #CLAR-09007, 2011, Clarus, OPEN

31. A self-selection study for the consideration of tamsulosin hydrochloride 0.4 mg in all comer’s population of adults with bothersome urinary symptoms followed by urological assessment of selected predefined subpopulations, Protocol #527.83, 2012 OPEN

32. Auxilium aux-cc-806: a phase 3, open-label study of the safety and effectiveness of aa4500 administered twice per treatment cycle for up to four treatment cycles (2×4) in men with Peyronie’s disease 2012 OPEN

33. Phase IV, Open-Label Study of Oral Testosterone Undecanoate in Hypogonadal Men, CLAR-12010, Clarus Therapeutics, Inc. 2012  OPEN