Clinical Trial Watch April 2014

This list of U.S.-based National Institutes of Health trials is derived from the NIH’s database and includes phase I-IV hypogonadism and BPH trials that are currently recruiting participants. This list is current as of April 7, 2014. For more information, view the complete database at http://ClinicalTrials.gov.

Hypogonadism

LutrePulse Hypogonadotropic Hypogonadism

Sponsor(s): Ferring Pharmaceuticals

Identifier: NCT01976728

Oral Testosterone for the Treatment of Hypogonadism

Sponsor(s): TesoRx Pharma, LLC

Identifier: NCT01717768

Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism

Sponsor/Collaborators: Lipocine Inc.; INC Research; PPD

Identifier: NCT02081300

Testosterone Replacement for Male Opioid Agonist Maintained Patients

Sponsor(s): Yale University

Identifier: NCT01873989

A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62%

Sponsor(s): Repros Therapeutics Inc.

Identifier: NCT01993212

Continue to next page for more trials.

Testosterone Replacement in Men With Diabetes and Obesity

Sponsor/Collaborators: Kaleida Health; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Identifier: NCT01127659

Clomid in Men With Low Testosterone With and Without Prior Treatment

Sponsor(s): Phoenix VA Health Care System

Identifier: NCT01904734

Administration of Kisspeptin to Subjects With Reproductive Disorders

Sponsor(s): Massachusetts General Hospital

Identifier: NCT00914823

Testosterone and Pain Sensitivity

Sponsor/Collaborators: Johns Hopkins University; Endo Pharmaceuticals

Identifier: NCT01689896

Pulsatile GnRH in Anovulatory Infertility

Sponsor/Collaborators: Massachusetts General Hospital; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Identifier: NCT00383656

Clomiphene Citrate for the Treatment of Low Testosterone Associated With Chronic Opioid Pain Medication Administration

Sponsor(s): Weill Medical College of Cornell University

Identifier: NCT01880086

A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and Energy

Sponsor(s): Eli Lilly and Company

Identifier: NCT01816295

CYP19A1 Gene and Pharmacogenetics of Response to Testosterone Therapy

Sponsor(s): Department of Veterans Affairs

Identifier: NCT01378299

Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling

Sponsor(s): Massachusetts General Hospital

Identifier: NCT01438073

An Efficacy and Safety Study of ABT-SLV176 for the Treatment of Hypogonadal Men

Sponsor(s): AbbVie

Identifier: NCT02082197

Testosterone and Alendronate in Hypogonadal Men

Sponsor/Collaborators: Massachusetts General Hospital; Endo Pharmaceuticals; Merck Sharp & Dohme Corp.

Identifier: NCT01460654

Kisspeptin in the Evaluation of Delayed Puberty

Sponsor(s): Massachusetts General Hospital

Identifier: NCT01438034

Evaluation of Pharmacokinetic and Safety Profile of Androxal in Male Subjects With Impaired Renal Function

Sponsor(s): Repros Therapeutics Inc.

Identifier: NCT01923857

Continue to next page for BPH trials.

BPH

Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)(NX02-0022)

Sponsor(s): Nymox Corporation

Identifier: NCT01846793

Post-Marketing Study Using PROLIEVE for the Treatment of Benign Prostatic Hyperplasia (BPH)

Sponsor(s): Medifocus, Inc.

Identifier: NCT02021032

Prostate Artery Embolization With Embosphere Microspheres Compared to TURP for Benign Prostatic Hyperplasia

Sponsor(s): Merit Medical Systems, Inc.

Identifier: NCT01789840

Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of Intraprostatic PRX302 for LUTS BPH

Sponsor(s): Sophiris Bio Corp

Identifier: NCT01966614

Prostate Embolization for Benign Prostatic Hyperplasia

Sponsor/Collaborators: Georgetown University; James B. Spies, MD

Identifier: NCT01924988

Effectiveness of onaBoNT-A vs Oral Tamsulosin in Men With Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms (BPH)

Sponsor(s): Department of Veterans Affairs

Identifier: NCT01589263

Efficacy and Safety of S-Equol on Men With Benign Prostatic Hyperplasia

Sponsor(s): Ausio Pharmaceuticals, LLC

Identifier: NCT00962390

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