Publications by authors named "Marc Gittelman"
Background: Long-term data evaluating the efficacy and safety of oral testosterone undecanoate (oral TU; JATENZO) in adult hypogonadal men provides important information for healthcare professionals who prescribe testosterone replacement therapy (TRT).
Aim: To determine the efficacy and safety of long-term oral TU therapy, including its impact on total testosterone (T) levels and psychosexual functioning.
Methods: Hypogonadal men, between 18 and 75 years old, (mean age 56.
Background: To improve symptoms associated with testosterone deficiency, many testosterone therapies are available that aim to restore serum testosterone (T) levels to the normal physiologic range. The magnitude, frequency, and duration between peak and trough T concentrations vary with route of administration, and none reflect normal endogenous daily diurnal T variations.
Objective: To compare pharmacokinetic profiles of serum T from approved T formulations with endogenous diurnal T variations in young and older men, and to consider whether there may be value in mimicking the diurnal T rhythmicity with exogenous testosterone therapies as men age.
Purpose: We present final 5-year outcomes of the multicenter randomized sham-controlled trial of a water vapor therapy (Rezūm™) for treatment of moderate to severe lower urinary tract symptoms due to benign prostatic hyperplasia.
Materials And Methods: A total of 197 subjects 50 years of age with International Prostate Symptom Score ≥13, maximum flow rate ≤15 ml/second and prostate volume 30 to 80 cc were randomized and followed for 5 years. From the control arm of 61 subjects, a subset of 53 subjects requalified and after 3 months received treatment as part of the crossover group and were also followed for 5 years.
Context: A novel formulation of oral testosterone (T) undecanoate (TU) was evaluated in a phase 3 clinical trial.
Objective: Determine efficacy, short-term safety, and alignment of new oral TU formulation with current US approval standards for T replacement therapy.
Design: Randomized, active-controlled, open-label study.
Introduction: We determined whether consumers who self-select to use tamsulosin for urinary symptoms can make appropriate decisions without health care provider guidance in a simulated over-the-counter setting.
Methods: In a simulated retail setting eligible participants (18 years old or older) reviewed a mock-up of Flomax® over-the-counter packaging and determined whether it was right for them to use tamsulosin capsules (0.4 mg).
Introduction: We assessed the ability of men with bothersome urinary symptoms to use an over-the-counter tamsulosin (0.4 mg) product concordant with the information in the proposed drug facts label in a simulated over-the-counter setting.
Methods: Eligibility for this 24-week study was determined by a phone interview.
Background: Tamsulosin remains the single most popular uroselective alpha adrenoceptor antagonist approved for the treatment of lower urinary tract symptoms (LUTS) attributable to benign prostatic hyperplasia (BPH). Over the last 3 decades, the utilization of tamsulosin has extended to conditions beyond its original indication. To identify potential changes to prescribing patterns and the extent of tamsulosin use for conditions beyond its original indication, we evaluated tamsulosin dispensing patterns in the United States using a large, multi-payer claims database.
View Article and Find Full Text PDFIntroduction: Patients with testosterone deficiency (TD) can be treated with exogenous testosterone (T) to achieve and maintain physiologic T levels and prevent negative clinical symptoms; with many testosterone replacement therapies currently available, this registration safety study was conducted to further characterize the clinical profile of chronically administered, concentration-guided subcutaneous testosterone enanthate (TE) dosing.
Aim: The purpose of this study was to confirm the safety and characterize the pharmacokinetic (PK) profile of the subcutaneous TE auto-injector (SCTE-AI) in adult men with TD.
Methods: In this phase III, 26-week study, 133 men 18-75 years of age with symptomatic TD self-administered SCTE-AI 75 mg once weekly for 6 weeks from July 2015 to June 2016.
Introduction: Treatment for lower urinary tract symptoms (LUTS) is often delayed, as it is considered a natural progression of aging. We described baseline demographic and clinical characteristics of men currently not using prescription medications for benign prostatic hyperplasia (BPH) but interested in self-directed use of over-the-counter (OTC) tamsulosin and who had participated in OTC tamsulosin-simulated studies.
Materials And Methods: Pooled baseline data from four OTC tamsulosin-simulated studies were analyzed for men who were currently not using BPH prescription medication and who believed that OTC tamsulosin was appropriate for use or were interested in purchasing it.
Background: Lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH) are common in men, considerably affecting quality of life.
Aims: The self-directed use of over-the-counter (OTC) tamsulosin (0.4 mg) and potential safety risks were evaluated in an open-label, uncontrolled, exploratory, 8-week OTC-simulated study.
Introduction: Lower urinary tract symptoms have a multifactorial etiology, are common in men and increase with age. In view of the unprecedented growth of the aging population worldwide and in the United States, an increase in the number of men with lower urinary tract symptoms is expected in the near future. In contrast, a decline in the number of practicing urologists is projected.
View Article and Find Full Text PDFObjective: Testosterone replacement therapy is indicated for male hypogonadism. This study aimed to evaluate the efficacy and safety of testosterone gel 2% (Tgel) over 90 days.
Methods: This phase 3, open-label, noncomparator study was conducted in adult hypogonadal men (2 consecutive fasting serum testosterone values <300 ng/dL and >86% subjects with symptoms consistent with testosterone deficiency).
Purpose: We report 2-year outcomes of a multicenter randomized controlled trial plus 1-year results of a crossover trial after treatment with convective radiofrequency water vapor thermal energy for lower urinary tract symptoms due to benign prostatic hyperplasia.
Materials And Methods: A total of 197 men at least 50 years old with I-PSS (International Prostate Symptom Score) 13 or greater, maximum flow rate 15 ml per second or less and prostate size 30 to 80 cc were randomized 2:1 to thermal therapy with the Rezūm® System or a control group. Rigid cystoscopy with simulated active treatment sounds served as the control procedure.
Introduction: Androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) analogs is a standard treatment for advanced prostate cancer. GnRH analog therapy can reduce testosterone to "castrate" levels, historically defined as <50 ng/dL. With the advent of newer assays, a lower threshold of <20 ng/dL has recently been proposed.
View Article and Find Full Text PDFIntroduction: Most surgical treatments for male lower urinary tract symptoms and benign prostatic hyperplasia affect erectile and ejaculatory functions negatively, leading to patient dissatisfaction.
Aim: To determine whether water vapor thermal therapy, when conducted in a randomized controlled trial, would significantly improve lower urinary tract symptoms secondary to benign prostatic hyperplasia and urinary flow rate while preserving erectile and ejaculatory functions.
Methods: Men at least 50 years old with International Prostate Symptom Scores of at least 13, a peak flow rate of at least 5 to no higher than 15 mL/s, and prostate volume of 30 to 80 cm(3) were randomized 2:1 between Rezūm System thermal therapy and control.
Purpose: This report reveals the results of a multicenter, randomized, controlled study using transurethral prostate convective water vapor thermal energy to treat lower urinary tract symptoms associated with benign prostatic hyperplasia.
Materials And Methods: Men 50 years old or older with an International Prostate Symptom Score of 13 or greater, maximum flow rate of 15 ml per second or less and prostate size 30 to 80 cc were randomized 2:1 between thermal therapy with the Rezūm® System and control. Thermal water vapor was injected into the transition zone and median lobe as needed.
Purpose: We determine if men with self-reported lower urinary tract symptoms can make a correct decision to use an over-the-counter alpha-1 blocker. Furthermore, we assess the frequency of medically significant conditions presenting with urinary symptoms in these consumers.
Materials And Methods: Subjects reviewed a mock-up of an over-the-counter product for male lower urinary tract symptoms (part 1).
Background: A need remains for new therapeutic approaches for men with advanced prostate cancer, particularly earlier in the disease course.
Objective: To assess the ability of an oral selective estrogen receptor α agonist (GTx-758) to lower testosterone concentrations compared with leuprolide while minimizing estrogen deficiency-related side effects of androgen-deprivation therapy.
Design, Setting, And Participants: Hormone-naive advanced prostate cancer patients were randomized to oral GTx-758 1000 mg/d, 2000 mg/d, or leuprolide depot.
Purpose: We evaluated the efficacy and safety of a once monthly oxybutynin vaginal ring in women with overactive bladder.
Materials And Methods: This randomized, multicenter, double-blind, 12-week phase 2 study compared oxybutynin vaginal ring (4 or 6 mg daily) to a placebo vaginal ring in women with well-defined overactive bladder symptoms. The primary efficacy variable was the change from baseline to week 12 in the total weekly number of incontinence episodes (stress and urge).
Purpose: We evaluated the clinical usefulness of the PROGENSA® PCA3 Assay for predicting repeat prostate biopsy outcome.
Materials And Methods: Men with at least 1 prior negative prostate biopsy who were scheduled for repeat prostate biopsy based on best clinical judgment were enrolled at 14 centers. Whole blood and post-digital rectal examination urine samples were collected before extended template transrectal biopsy with 12 or more cores.
Purpose: We evaluated the efficacy and safety of silodosin for treatment of benign prostatic hyperplasia symptoms in 2 randomized, placebo controlled, phase 3 studies.
Materials And Methods: Men 50 years or older with an International Prostate Symptom Score of 13 or greater and peak urinary flow rate of 4 to 15 ml per second received placebo or 8 mg silodosin daily with breakfast for 12 weeks. The primary end point was International Prostate Symptom Score change from baseline to last observation.
Introduction: Patients and physicians consider a rapid onset of action to be an important attribute of oral pharmacotherapy for erectile dysfunction.
Aim: To investigate the time to onset of action of a new orodispersible tablet (ODT) formulation of vardenafil.
Methods: A post hoc integrated analysis was performed on data from two 12-week, double-blind, multicenter, randomized, parallel-group, placebo-controlled phase III trials of 10 mg vardenafil ODT.
Objective: To evaluate the efficacy and tolerability of a once-yearly histrelin implant during an open-label extension of a pivotal study.
Patients And Methods: Men with advanced prostate cancer and a clinical response to 52 weeks of treatment with the histrelin implant. Implants were placed annually.