Curriculum Vitae For:
John Bernard Brinkman, M.D.
Northeast Indiana Research, LLC
2512 East Dupont Road, Suite # 100
Fort Wayne, Indiana 46825
Research Office Phone: (260) 434-1939
Research Office Fax: (260) 434-1418
Research E-Mail Address: jbrinkman@northeastindianaresearch.com

Education:
1990-1993 Urology Residency, The Ohio State University Hospitals, Columbus, OH
1989-1990 General Surgery Residency, The Ohio State University Hospitals, Columbus, OH
1988-1989 General Surgery Internship, The Ohio State University Hospitals, Columbus, OH
1984-1988 Doctor of Medicine, Indiana University, School of Medicine, Indianapolis, IN
1980-1984 B.S., Biology, Indiana University, Bloomington, IN (Magna Cum Laude)

Work Experience:
1993-Present Northeast Indiana Urology, PC, Fort Wayne, Indiana
1993-Present Northeast Indiana Research, Fort Wayne, Indiana

Credentials:
Medical License: Indiana #01041265A
Board Certification: American Board of Urology 2/96

Hospital Affiliations:
1993-Present Urologist, Parkview Memorial Hospital, Fort Wayne, Indiana
1993-Present Urologist, Lutheran Hospital of Indiana, Fort Wayne, Indiana
1993-Present Urologist, Huntington Memorial Hospital, Huntington, Indiana
2000-Present Urologist, Dupont Surgery Center, Fort Wayne, Indiana
2001-Present Urologist, Dupont Hospital, Fort Wayne, Indiana

Professional Affiliations:
American Urological Assoication

Honors and Awards:
Phi Beta Kapa
Surgical Intern of the Year, 1988-1989, The Ohio State University Hospital, Columbus, OH

Research Activities:

  • Safety and Tolerability of Long-term Administration of XXXX.
  • A Repeated-Dose Evaluation of Analgesic Use and Safety of XXXXX in Patients with Chronic Non-Malignant Pain.
  • A Repeated-Dose Evaluation of Analgesic Use and Safety of XXXXX In Patients with Chronic Cancer Pain
  • The Safety and Activity of Three Doses of XXXXX Compared to XXXXX in the treatment of Herpes Zoster in Immunocompetent Adults.
  • A Randomized, Multicenter, Open-Label, Dose-Ranging Study Comparing the Safety and Efficacy of XXXX to XXXX in Women with Endometriosis-Associated Pain.
  • A Phase III, Efficacy and Safety Study Comparing Escalating doses of XXXX to 5mg, 6mg, Doses of XXXX or Placebo in the Treatment of Male Erectile Dysfunction.
  • A Phase III, Efficacy and Safety Study of Four Fixed Doses of XXXX SL Tablet versus Placebo in the Treatment of Male Erectile Dysfunction
  • A Phase III, Long-Term, Open-Label, Flexible Dose, Efficacy and Safety Study of XXXX Tablets in the Treatment of Male Erectile Dysfunction
  • A Phase II, Safety Study of 5 mg XXXXX versus Placebo in the Treatment of Patients diagnosed with Male Erectile Dysfunction Following a Bilateral Nerve-Sparing Radical Retropubic Prostatectomy.
  • A Randomized, Multicenter, Double-Blind, Double-Dummy Comparative Trial of XXXX and XXXX for the Treatment of Bacterial Prostatitis.
  • A Phase II, Open-Label Trial of XXXX in Complicated Urinary Tract Infections.
  • A Randomized, Double-Blind, Multicenter, Phase II/III Comparison of XXXX to XXXX in the Treatment of Complicated Urinary Tract Infection and Pyelonephritis.
  • Phase II, Multicenter, Open-label Study of XXXX, Administered as a Subcutaneous, Continuous Infusion for 57 to 85 days (8 to 12 weeks) in Patients Undergoing Radiation Therapy Interstitial Seed Implantation or Other Radiation Therapy.
  • Clinical Trail to Assess the Efficacy and Safety of XXXX in Hormone Refractory Stage D2 Prostate Cancer
  • A Multicenter, Randomized, Open-Label Trial to Compare Bone Mineral Density and Fat Free Mass in Men Given Either XXXX 10.8mg Depot or XXXX 150mg for Treatment of Prostate Cancer
  • A Randomized, Double-Blind comparative trial of XXXX versus Placebo in Patient with Early Prostate Cancer
  • A Phase III, Multicenter, Open-Label, Randomized Study of XXXX vs. XXXX plus daily XXXX in Patients with Prostate Cancer who are Candidates for Initial Hormonal Therapy
  • A Randomized, Double-Blind, Placebo Controlled, Two-Year, parallel Group Study of the Efficacy and Safety of XXXX 0.5mg in the Treatment and Prevention of Progression of Benign Prostatic Hyperplasia.
  • A Phase II/III, Double-Blind, Placebo Controlled, Dose-Finding Study of the Safety and Efficacy of XXXX in Patients with Symptomatic Benign Prostatic Hyperplasia (BPH)
  • An Eleven-Week, Open-Label, Randomized, Multicenter, Parallel-Design, Placebo Lead-In Study of XXXX Capsules, 0.4mg Daily versus XXXX Capsules, 5mg (with XXXX) daily in Patients with the Signs and Symptoms of Benign Prostatic Hyperplasia.
  • Clinical Efficacy and Safety of XXXX as Compared to XXXX and Placebo. A Phase III, Randomized, Double-Blind, Multinational Study in Patients with Detrusor Overactivity and symptoms of Frequency, Urge Incontinence and Urgency.
  • Clinical Efficacy and Tolerability/Safety of XXXX Prolonged Release Capsules and XXXX Immediate Release Tablets vs. Placebo. A Randomzied, Double-Blind, Placebo controlled, Multinational Study in Patients with Symptoms of Overactive Bladder
  • Clinical Trial to Investigate XXXX Insert as an Intraurethral Device Intended to be used for the Management of Stress Urinary Incontinence in Adult Females
  • An Evaluation on Effect of 20mg XXXX on Sperm Concentration in Normal Healthy Subjects or Subject with Mild Erectile Dysfunction.
  • A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of XXXX for the Treatment of Male Erectile Dysfunction in an At-Home Setting.
  • An Open-Label, Continuation Trial of XXXX in Male Erectile Dysfunction Patients Who Previously Participated in a Parent Study.
  • A Randomized, Double-Blind, Placebo-Controlled Study to Assess Duration of Responsiveness to XXXX in Patients with Erectile Dysfunction.
  • A Randomized, Double-Blind, Crossover Study of XXXX Compared with XXXX for the Treatment of Patients with Erectile Dysfunction.
  • Long-Term Efficacy and Safety of XXXX 10mg OD on the Risk of Acute Urinary Retention and the Need for Surgery in Patients with BPH. A Two-Year, Randomized, Multicenter, Double-Blind, Parallel Group, Placebo-Controlled Study.
  • An Open-Label Comparison of Neoadjuvant Hormonal Therapy (NHT) with XXXX 100mg IM or XXXX 7.5mg IM in Patients with Prostate Cancer Planned to Undergo Brachytherapy or External-beam Radiation Therapy.
  • Evaluation of the Use of a Unique Testosterone XXXX Formulation in Males With a Testosterone Level < 300 ng/dL.
  • Efficacy and Safety of XXXX Compared With Placebo in Subjects with Stress Urinary Incontinence.
  • Long Term Monitoring of Safety in Subjects Treated with XXXX for Stress Urinary Incontinence.
  • A Randomized, Placebo-Controlled, Double-Blind, Parallel Design Study of the Efficacy and Safety of XXXX Cream in Premenopausal Patients With Female Sexual Arousal Disorder.
  • A Multi-Center, Double-Blind, Double-Dummy, Randomized, Placebo and XXXX Controlled Parallel Group Study to Assess the Efficacy and Safety of XXXX in Subjects with Lower Urinary Tract Symptoms Due to Benign Prostatic Obstruction.
  • A Two Phase, Double-Blinded, Randomized, Multicenter, Parallel-Design Study of XXXX Capsules, 0.4 mg Daily versus Placebo, in Male Patients with Acute Urinary Retention Related to Benign Prostatic Hyperplasia.
  • A Placebo-Controlled, Double-Blind, Randomized, Crossover Study of the Efficacy and Safety of XXXX in the Treatment of Rapid Ejaculation.
  • A Multi-Center, Randomized, Double-Blind, Placebo Controlled Crossover Trial to Assess the Effect of XXXX 160mg on Penile Rigidity and XXXX in Patients with Mild to Moderate Erectile Dysfunction.
  • A Multicenter, Double-Blind Study to Compare the Safety and Efficacy of XXXX to That of XXXX in the Treatment of Chronic Prostatitis.
  • A Randomized Double Blind Placebo Controlled Study of XXXX Provided to Patients with Erectile Dysfunction.
  • A Randomized Placebo Controlled Double Blind Parallel Design Phase III Trial of the Efficacy and Safety of XXXX in Patients with Erectile Dysfunction.
  • A Four-Week “Proof of Concept” Study to Determine the Safety Tolerability and Efficacy of Oral XXXX in Patients with Symptoms of Urinary Urgency and Frequency with or without Incontinence.
  • Multi Center Double Blind Study of the Safety and Efficacy of XXXX vs. Placebo for Treatment of Hypogondal Men Who are Non-Responders to XXXX.
  • Prospective Randomized, Double-Blind Multi-Center Comparative Trial To Evaluate the Efficacy and Safety of XXXX Once-Daily (QD) Modified Release (XXXX MR) Tablets 1000mg Conventional XXXX 500mg Tablets in the 7-14 Day Treatment of Patients With Complicated Urinary Tract Infections (cUTI) or Acute Uncomplicated Pyelonephritis.
  • Phase I/II Dose Escalation and Efficacy Trial of XXXX in Patients With Metastatic Hormone-Refractory Prostate Cancer.
  • Randomized, Double-Blind, Placebo-Controlled, 2-Way Crossover Study To Investigate The Time-to-Onset (time to reach > 55% of penile rigidity, as measured by the RigiScan device), of a Single Oral Dose of XXXX Compared To Placebo In Male Patients With Erectile Dysfunction.
  • A Randomized, Double Blind, Multi Center, Fixed Dose, Cross Over Study To Investigate The Efficacy and Safety of 20mg of XXXX Given on Demand in Comparison To 100mg of XXXX Given on Demand In Males With Erectile Dysfunction And a Diagnosis of Diabetes Mellitus and/or Hypertension and/or Hyperlipidemia.
  • An Open-Label Study To Evaluate The Feasibility of Switching To Treatment With An LHRH Agonist Following 4 Weeks of Treatment With XXXX In Patients With Prostate Cancer.
  • A Randomized, Placebo-Controlled, Double-Blind, Crossover Design Phase 2 Study of the Efficacy and Safety of XXXX In Patients With Erectile Dysfunction Using Rigidity and Tumescence Monitoring.
  • A Multicenter, Fixed Dose Study With a Double-Blind, Randomized, Placebo-Controlled, Parallel Group Phase, And An Open Label Phase To Investigate The Time To Onset of Activity of XXXX.
  • A Double-Blind, Randomized, Crossover Evaluation of Safety And Efficacy of XXXX With Visual Sexual Stimulation In Patients With Erectile Dysfunction.
  • Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Efficacy of XXXX in Delaying the Systemic Progression of Prostate Cancer in Patients With Intermediate to High Risk of Recurrence With Rising PSA Levels After Prostatectomy and Radiotherapy or Radiotherapy Alone for Localized Disease.
  • A Phase 3B Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study of XXXX in Subjects with Overactive Bladder.
  • An Open-Label Study to Evaluate the Feasibility of Switching to Treatment with an LHRH Agonist Following 12 Weeks of Treatment with XXXX in Patients with Prostate Cancer.
  • A Multicenter, Open-Label, Flexible Dose Escalation Study to Evaluate the Correlation Between Event Log Parameters, Self Esteem/Overall Relationships, and Efficacy of XXXX in Men with Erectile Dysfunction.
  • A Phase III, Multinational, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled 24-week Study to Evaluate the Efficacy and Safety of XXXX in Naturally Menopausal Women with Hypoactive Sexual Desire Disorder on Concurrent Oral Hormone Replacement Therapy.
  • A Phase III, Multinational, Randomized, Double-Blind, Parallel Group, Placebo-Controlled 24-week Study to Evaluate the Efficacy and Safety of XXXX in Women with Hypoactive Sexual Desire Disorder on Concurrent Estrogen Replacement Therapy Who Have Undergone Hysterectomy and Bilateral Oophorectomy.
  • A Randomized, Double-Blind, Placebo-Controlled, Fixed Dose, Multi-Center Study to Evaluate the Efficacy, Safety and Toleration of Oral XXXX Administered for 12 Weeks to Post-Menopausal Women Who Have Been Diagnosed With Female Sexual Arousal Disorder.
  • A Randomized, Double-Blind, Double Dummy, Placebo-Controlled, Fixed Dose, Multi-Center Study to Evaluate the Efficacy, Safety and Toleration of Oral XXXX Administered for 12 Weeks to Pre-Menopausal Women Who Have Been Diagnosed With Female Sexual Arousal Disorder.
  • A Randomized, Double-Blind, Parallel Placebo-Controlled Study in Men with Erectile Dysfunction to Evaluate the Efficacy and Safety of XXXX when Sexual Attempts Occur at Specific Time Points after Dosing.
  • Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of a Partial XXXX, in Women with Stress Urinary Incontinence or Mixed Urinary Incontinence.
  • A Multi-Center, Multi-Nation Observational, Study to Document Treatment and Standard of Care for Subjects with Metastatic Hormone Refractory Prostate Cancer.
  • An Open-Label, Multi-Center Extension Study to Evaluate the Safety, Toleration and Sustained Efficacy of Oral XXXX Administered to Women Who Have Been Diagnosed with Female Sexual Arousal Disorder.
  • A Double-Blind, Placebo-Controlled, Randomized US Study to Evaluate the Effect of XXXX Prolonged Release on Nocturia in Patients with Symptoms of Overactive Bladder (OAB).
  • Collection of Sexual Information in a Four-Week Outpatient Study in Normal Women.
  • A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study of the Efficacy and Safety of XXXX 0.5mg Administered Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer.
  • A Placebo-Controlled, Randomized, Double-Blind Parallel Group, Dose-Finding, At-Home Study to Evaluate the Efficacy and Safety of Intranasally Administered XXXX in Subjects with Male Erectile Dysfunction.
  • A Multi-Center, Double-Blind, Placebo-Controlled, Dose-Titration Study of XXXX Transdermal Systems in Patients with Overactive Bladder.
  • A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of XXXX Topical Solution in Patients with Interstitial Cystitis.
  • Phase III, Pharmacokinetic, Safety, and Efficacy Study of a Six-Month Depot Formulation of XXXX in Subjects with Prostatic Adenocarcinoma.
  • Prospective, Randomized, Double-Blind, Placebo-Controlled Evaluation of Topical XXXX Administered at Home for the Treatment of Premenopausal Women with Female Sexual Arousal Disorder (FSAD).
  • A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Reliability of 10mg XXXX Administered for 12 weeks Compared to Placebo in Subjects with Erectile Dysfunction and a Demonstrated Successful First Response to 10mg XXXX.
  • The Effect of XXXX Compared to Placebo on Bone Mineral Density in Patients Undergoing Androgen Deprivation Therapy.
  • A Phase III, Randomized, Double-Blind, Placebo-Controlled, Flexible Dose, Multi-Center Study to Evaluate the Efficacy, Safety and Toleration of Oral XXXX Administered for 12 weeks to Post-Menopausal Women Receiving Hormone Replacement Therapy and Who Have Been Diagnosed with Female Sexual Arousal Disorder.
  • Prospective, Observational Registry Study of the Management of Men with Symptomatic Benign Prostatic Hyperplasia (BPH): Observational Registry in BPH Initial Treatment (Orbit) Alpha-Testing Phase.
  • A Double-Blind, Randomized, Crossover Evaluation of Safety and Efficacy of XXXX Administered at Home in Patients with Erectile Dysfunction.
  • A Double-Blind, Placebo-Controlled, Multicenter Randomized, Phase-3 Study of XXXX in the Treatment of Anemia in Cancer Subjects Not Currently Treated with Chemotherapy or Radiotherapy.
  • An Evaluation of Semen Characteristics After 40 Weeks Daily Dosing with 20mg XXXX.
  • A Multicenter, Open Label, Flexible Dose Study To Investigate the Use Patterns of XXXX and the Ability of Investigators to Further Optimize Subject Satisfaction With XXXX Through Customized Instruction.
  • The Safety of XXXX on Sperm Motility in Healthy Male Subjects.
  • An Open-Label, Randomized, Multi-Center, Parallel Group Comparison of the Efficacy and Safety of XXXX at Two Different Dosing Regimens in Patients with Prostate Cancer Dosed for Thirteen 28-Day Cycles.
  • A Double-Blind, Randomized, Placebo-Controlled Trial of XXXX for the Treatment of Chronic Non-Bacterial Prostatitis.
  • A Double-Blind, Randomized, Parallel Group Trial of XXXX Extended Release Tablets or Placebo in Combination with XXXX for the Treatment of Lower Urinary Tract Symptoms.
  • A Phase 3, Parallel Group, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Investigate the Efficacy, Tolerability and Safety of XXXX Sustained Release in Subjects with Overactive Bladder Syndrome.
  • A Phase 2B, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group Dose Response Study to Assess the Efficacy and Safety of Oral XXXX In Men With Premature Ejaculation.
  • A Double-Blinded, Randomized, Evaluation of the Safety and Efficacy of XXXX in Subjects with Erectile Dysfunction.
  • A Multicenter, Randomized, Paralled Group, Double-Blind, Placebo Controlled Flexible Dose Study with an Open-Label Extension to Assess the Efficacy and Safety of XXXX in the Treatment of Men With Erectile Dysfunction (ED) and Concomitant Lower Urinary Tract Symptoms (LUTS) Associated with Benign Prostatic Hyperplasia (BPH) in the United States.
  • An Observational Study To Evaluate Patient Reported Outcomes In Subjects With and Without Premature Ejaculation.
  • XXXX Therapy for Non-Responders to 5g of XXXX.
  • Evaluation of the Effect of Transdermal Testosterone Supplementation on Glycemic Control, Body Composition, and Lipid Concentrations in Hypogonadal Men With Non-Insulin-Dependent Diabetes Mellius.
  • Evaluation of the Safety and Tolerability of XXXX When Co-Administered With a PDE5 Inhibitor in Men With Erectile Dysfunction and Hypogonadism.
  • A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, 52-week Study to Evaluate the Efficacy the Efficacy and Safety of Transdermal Patches Delivering 150 or 300 µ/day Testosterone in Menopausal Women With Low Libido Not Receiving Systemic Estrogen or Estrogen Progestin Therapy.
  • A Double-Blind, Randomized, 6-Month Evaluation of the Safety and Efficacy of Topical XXXX in Hysterectomized Women With Female Sexual Arousal Disorder (FSAD).
  • A Randomized, Double-Blind, Placebo-Controlled Study To Evaluate XXXX in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-Metastatic Prostate Cancer.
  • A Phase II, Placebo-Controlled, Double-Blind, Dose-Ranging Randomized, Multi-Center Study of XXXX in Older Hypogonadal Males Ages 60-80: Effect on Body Composition, Libido, and Physical and Sexual Functioning.
  • A Randomized, Placebo-Controlled, Double-Blind, Parallel Design Phase 2 Dose Ranging Trial To Assess the Safety and Efficacy of XXXX Tablets in Male Subjects with Erectile Dysfunction.
  • A Multicenter, Parallel-Arm, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of XXXX Administered Once Daily to Men with Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.
  • Effect of XXXX on Valsalva Leak Point Pressure and Quantitative Rhabdosphincter Electromyography (EMG) Measures in Women with Stress Urinary Incontinence (SUI).
  • A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of XXXX in Postmenopausal Women with Overactive Bladder.
  • A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of XXXX (7.5mg o.d. with voluntary up-titration to 15mg o.d.) in Patients Aged > 65 Years with Overactive Bladder.
  • A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Two-Period Cross-Over Trial to Validate Patient-Reported Outcome Measures for Use in Men with Late-Onset Hypogonadism.
  • A Multi-Center, Double-Blind, Randomized Study to Compare the Efficacy and Safety of XXXX, 750mg Once Daily for Five Days Versus XXXX Twice Daily for Ten Days in the Treatment of Complicated Urinary Tract Infection or Acute Pyelonephritis.
  • A Placebo-Controlled, Randomized, Double-Blind, Fixed-Dose, At-Home Study to Evaluate the Efficacy and Safety of Intranasally Administered XXXX in Subjects with Erectile Dysfunction.
  • A Placebo-Controlled, Randomized, Double-Blind, Fixed-Dose, At-Home Study to Evaluate the Efficacy and Safety of Intranasally Administered XXXX in Subjects with Erectile Dysfunction and Diabetes Mellitus.
  • Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Assess the Time to Onset, Safety, and Toleration of Differing Doses and Combinations of Immediate Release and Modified Release Formulations of XXXX in Adult Male Subjects with Erectile Dysfunction.
  • Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study of Men with Mild to Moderate Erectile Dysfunction to Evaluate the Efficacy of XXXX 8 Hours Post-Dose.
  • Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study of Men With Mild to Moderate Erectile Dysfunction to Evaluate the Efficacy of Viagra 8 Hours Post-Dose.
  • A Randomized, Double-Blind, Placebo-Controlled, Dose Comparison Study of The Efficacy and Safety of XXXX for the Treatment of Symptomatic Benign Prostatic Hyperplasia.
  • A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Evaluation of the Efficacy and Safety of XXXX in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia.
  • A Placebo-Controlled Randomized, Double-Blind, Parallel-Group, At-Home Exploratory Study to Evaluate the Efficacy and Safety of Intranasally Administered XXXX in Subjects with Female Sexual Arousal Disorder (FSAD).
  • A Randomized, Placebo-Controlled, Double-Blind, Parallel Design Trial of the Efficacy and Safety of XXXX in Women with Mixed Desire/Interest/Arousal/Orgasm Disorders.
  • A Two-Arm, Open-Label, Randomized, Multi-Center Pharmacokinetic and Long-Term Safety Study of Intramuscular Injections of XXXXmg and XXXXmg XXXX in Hypogonadal Men.
  • A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Study Evaluating the Efficacy, Safety, and Duration of Erection of Flexible Dose XXXX Administered for 12 Weeks Compared to Placebo in Subjects with Erectile Dysfunction and Dyslipidemia.
  • A Randomized Double Blind Phase III Study to Evaluate Adjuvant XXXX Treatment versus Placebo in Patients with Clear Cell RCC and High Risk of Recurrence.
  • A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of XXXX on Prolonging Bone Metastasis-Free Survival in Men with Hormone-Refractory Prostate Cancer.
  • A Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of XXXX in Extending the Time to Progression of Low-Risk, Localized Prostate Cancer in Men Who are Candidates for or Undergoing Expectant Management.
  • A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, 5-Group, Multinational Study to Evaluate the Efficacy, Dose Response, and Safety of XXXX Once-a-Day Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia.
  • A Multicentre, Placebo Controlled, Randomised, Double-Blind, Dose Ranging Study of XXXX 0.05 MG, 0.1 MG, 0.2 MG, XXXX 4 MG and Placebo Daily Doses for 4 Weeks in Patients Suffering from Overactive Bladder Syndrome.
  • A Four-Arm, Randomized, Double-Blind, Parallel, Placebo-Controlled Exploratory Study of XXXX 0.15 MG, 0.30 MG, and 0.60 MG in Men with Primary Premature Ejaculation.
  • A Twenty Four Week, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Trial of XXXX 50 Milligrams Daily and, with Uptitration, 100 Milligrams Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder.
  • A Phase III, Randomized, Double-Blind, Placebo-Controlled, and Open-Label Active-Controlled Study To Evaluate the Safety and Efficacy of XXXX Treatment in Men With Secondary Hypogonadism.
  • A Prospective Multicenter, Double-Blinded, Randomized Study to Evaluate Bleeding Patterns in Women Using One of Three Different Ascending EE Dose Extended Cycle (91-Day) Oral Contraceptive Regimens Compared to XXXX Oral Contraceptive Regimen.
    ? XXXX 5 mg Once a Day Compared to Placebo in Improving Sexual Quality of Life.
  • A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multicenter Study to Evaluate the Urodynamics Effects of XXXX Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia.
  • A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Flexible-Dose Study to Assess the Efficacy and Safety of XXXX in Men with Erectile Dysfunction Who Do not Self Identify.
  • A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Phase 3 Trial of Single-Dose Intravesical XXXX as a Surgical Adjuvant Instilled in the Early Postoperative Period in Patients Undergoing Transurethral Resection for Noninvasive Bladder Cancer.
  • XXXX intermittent IM dosage regimens in patients with symptomatic BPH: a 1 year placebo-controlled efficacy study and long-term safety assessment.
  • A Randomized, double-blind, placebo-controlled trial of the safety and efficacy of XXXX, in patients with lower urinary tract symptoms due to benign prostatic hypertrophy.A Phase III, Open-Label, Multi-Center, Safety and Efficacy Study of Oakwood Laboratories XXXX for Injectable Suspension 22.5 mg in Patients with Prostate Cancer.
  • A Randomized Double-Blind Parallel Group Study Comparing XXXX 50mg plus Placebo to XXXX 50mg plus XXXX 3.5mg Administered for 18 months to Men with Prostate Cancer Who Have Failed First-Line Androgen Deprivation Therapy (Assessed by Rising PSA) Followed by a Two-Year Extension Phase.
  • A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study, with Open-Label Follow on, to Evaluate the Efficacy, Safety and Tolerability of XXXX in Subjects with Premature Ejaculation.
  • A Phase III, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of the Beta-3 Agonist XXXX in Subjects with Symptoms of Overactive Bladder-ARIES.
  • A Randomized, Double-Blind, Parallel Group, Active Controlled, Multi-Center Long-Term Study to Assess the Safety and Efficacy of the Beta-3 Agonist XXXX (50 mg qd and 100 mg qd) in Subjects with Symptoms of Overactive Bladder – TAURUS.
  • A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of Two Doses of XXXX Versus Placebo in Women with Overactive Bladder.
  • A Phase 3, Multi-Center, Open-Label, Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of Two 6-Month XXXX Formulations, in Subjects with Prostatic Adenocarcinoma.
  • XXXX in patients with symptomatic BPH: an open-labeled safety and efficacy assessment study.
  • A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Efficacy and Safety of a XXXX Flexible Dose Regimen in Patients with Symptoms of Overactive Bladder including Nocturnal Urinary Urgency.
  • A Randomized, Placebo-Controlled, Double-Blind, Parallel Design, Phase 3 Study to Assess the Safety and Efficacy of XXXX Tablets in Male Subjects with Erectile Dysfunction.
  • Follow up study for REDUCE study subjects.
  • An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of XXXX in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-Metastatic Prostate Cancer.
  • XXXX 2.5mg and 5mg Once a Day Compared to Placebo in Day of Onset of Efficacy.
  • A Phase III Randomized, Double Blind, Placebo Controlled, Multicenter Study to Investigate the Efficacy and Safety of XXXX Nasal Spray Formulation in Patients with Nocturia.
  • A Phase III Open Label Extension Study to Investigate the Safety of XXXX Nasal Spray Formulations in Patients with Nocturia Completing Study SPC-SER120-DB1-200901 or Study SPC-SER120-DB2-200902.
  • A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of a Single Treatment of XXXX Purified Neurotoxin Complex Followed by a Treatment of XXXX as Applicable in Patients with Idiopathic Overactive Bladder with Urinary Incontinence.
  • An Open-Label Phase 3 Study to Evaluate the Long-Term Safety and Efficacy of XXXX Tablets in Male Subjects with Erectile Dysfunction.
  • A Phase 2 Clinical Study to Evaluate Daily Oral Doses of XXXX for 24 weeks in Men with Lower Urinary Tract Symptoms (LUTS) and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia (BPH).
  • A Phase II Study to Evaluate: Delay in Intravaginal Ejaculatory Latency Time (IELT), Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of XXXX in a Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study in Men with Premature Ejaculation.
  • A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of XXXX in Men with Premature Ejaculation and Concomitant Erectile Dysfunction Treated with a Phosphodietsterase-5 Inhibitor.
  • A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Intraporostatic Administration of XXXX to Treat Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia.
  • XXXX60 mg Efficacy in Female OAB Patients Refractory to Detrol LA 4mg Daily. A Multi-Center, Double-Blind, Placebo-Controlled Trial of XXXX60 mg Daily in Female OAB Patients on Multiple Concomitant Medications Refractory to Detrol LA 4mg Daily.
  • A Prospective Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of XXXX in Men with Premature Ejaculation and Concomitant Erectile Dysfunction Treated with a Phosphodiesterase-5 Inhibitor.
  • A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Intraprostatic Administration of XXXX to Treat Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia.
  • An Adaptive Phase 2B/3, Double-Blind, Randomized, Placebo-Controlled Study to Establish the Dosage Efficacy, and Safety of XXXX in Treating Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in Treatment-Naive Male Subjects.
  • A Phase II Study to Evaluate: Delay in Intravaginal Ejaculatory Latency Time (IELT), Safety, Tolerbility, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of XXXX in a Randomized, Double Blind, Placebo-Controlled, Parallel Group Study in Men with Premature Ejaculation.
  • An Open-Label, Six-Month Extension of Protocol MCS-2-US-a to Further Evaluate the Efficacy and Safety of XXXX for the Treatment of Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in Treatment-Naive Male Subjects.
  • A Randomised, Parallel-Arm, Open-Label Trial Comparing Degarelix with Goserelin Plus Anti-Androgen Flare Protection (Bicalutamide), in Terms of Prostate Size Reduction in Prostate Cancer Patients of Intermediate-To-Hig Risk, Who Require Neoadjuvant Hormone Therapy Prior to Radiotherapy (Curative Intent).
  • A Randomized Controlled, Open Label Trial of Degarelix Intermittent Therapy vs Continuous Androgen Deprivation Therapy with Leuprolide or Degarelix in Patients with Carcinoma of the Prostate with Biochemical Failure after Localized Therapy
  • A Pilot, Multicenter, Double-Blind, Placebo-Controlled, Dose-Escalation Study of the Safety and Efficacy of XXXX in Patients with Idiopathic Overactive Bladder and Urinary Incontinence.
  • A Randomized, Double-Blind, Phase II, Efficacy and Safety Study of XXXX vs Bicalutamide in Castrate Men with Metastatic Prostate Cancer.