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Kevin T McVary, Marc C Gittelman, Kenneth A Goldberg, Kalpesh Patel, Neal D Shore, Richard M Levin, Marc Pliskin, J Randolf Beahrs, David Prall, Jed Kaminetsky, Barrett E Cowan, Christopher H Cantrill, Lance A Mynderse, James C Ulchaker, Nicholas N Tadros, Steven N Gange, Claus G Roehrborn,

J Urol (The Journal of urology)
[2021, :101097JU000000000000177803]

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TLANDO, a Novel Oral TRT, Improves Sexual and Mental Domain Outcomes in Hypogonadal Men

Benjamin J Bruno, Kiran Vangara, Kilyoung Kim, Kongnara Papangkorn, Nachiappan Chidambaram, Mahesh V Patel, Anthony DelConte, Culley C Carson III, Irwin Goldstein, Jed Kaminetsky, Martin Miner, Mohit Khera,

Abstract Male hypogonadism is characterized by symptoms and deficiency (<300 ng/dL) in levels of in total testosterone (TT), a critical hormone for sexual, cognitive, and body function and development. TLANDO, a testosterone undecanoate (TU) comprising lymphatically delivered oral testosterone replacement therapy (TRT) option not requiring dose titration, treatment has demonstrated ... Read more >>

J Endocr Soc (Journal of the Endocrine Society)
[2021, 5(Suppl 1):A495-A496]

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Final 5-Year Outcomes of the Multicenter Randomized Sham-Controlled Trial of a Water Vapor Thermal Therapy for Treatment of Moderate to Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

Kevin T McVary, Marc C Gittelman, Kenneth A Goldberg, Kalpesh Patel, Neal D Shore, Richard M Levin, Marc Pliskin, J Randolf Beahrs, David Prall, Jed Kaminetsky, Barrett E Cowan, Christopher H Cantrill, Lance A Mynderse, James C Ulchaker, Nicholas N Tadros, Steven N Gange, Claus G Roehrborn,

<h4>Purpose</h4>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.<h4>Materials and methods</h4>A total of 197 subjects <u>></u>50 years of age with International Prostate Symptom Score ≥13, maximum flow ... Read more >>

J Urol (The Journal of urology)
[2021, :101097JU0000000000001778]

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Efficacy and Safety of TLANDO, A Novel Oral Easy to Prescribe and Use TRT Option

Kongnara Papangkorn, Kiran Vangara, Benjamin J Bruno, Kilyoung Kim, Nachiappan Chidambaram, Anthony DelConte, Mahesh Patel, Culley C Carson III, Irwin Goldstein, Jed Kaminetsky, Martin Miner, Mohit Khera, Adrian Sandra Dobs,

Abstract Most widely used testosterone replacement therapy (TRT) products can be inconvenient and cumbersome topical and invasive injectable requiring dose adjustments to attain efficacy. In a pivotal study, a recently approved oral TRT only 26% of patients did not require any dose adjustment. Typically, patients start on a sub-therapeutic dose ... Read more >>

J Endocr Soc (Journal of the Endocrine Society)
[2021, 5(Suppl 1):A486-A486]

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Northeastern Section of the AUA 72nd Annual Meeting Abstracts

Laura Donnelly, Jackie Tang, Fei Lian, Paul J. Higgins, Rohan Samarakoon, Karen Doersch, Kadija Abston, Hannah Kim, Xin Li, Jennifer Bjazevic, Anna-Lena Spierling, Kait F. Al, Hassan Razvi, Jeremy Burton, Jennifer Bjazevic, Kait F. Al, Jeremy P. Burton, Hassan Razvi, Gabriel Lachance, Karine Robitaille, Hélène Hovington, Alain Bergeron, Yves Fradet, Vincent Fradet, Connor Policastro, Michael Hughes, Francisco Martins, Jay Simhan, Nicolaas Lumen, Krishnan Venkatesan, Erick Alejandro Ramírez Pérez, Javier Angulo, Shubham Gupta, Paul Rusilko, Kirk Redger, Brian Flynn, Stephen Blakely, Dmitriy Nikolavsky, Kelly Pekala, Valentina Grajales, Hermoon Worku, Jordan Hay, Toby Zhu, Kody Armann, Chandler Hudson, Michelle Yu, Jathin Bandari, Benjamin Davies, Bruce Jacobs, Jessica Schardein, Matthew Beamer, Dmitriy Nikolavsky, Mauro Dispagna, Connor Policastro, Sergey Kravchick, Gregg Eure, Steven Gange, Andrew Hirsh, Hugh Reeves, Thomas Mueller, Peter Walter, Douglas Grier, Daniel Rukstalis, Sohrab Naushad Ali, Nicholas Paterson, Kristen McAlpine, Tinghua Zhang, Brian Blew, Neal Rowe, Charles Welliver, Lydia Feinstein, Julia Ward, Kevin Abbott, Ziya Kirkali, Erline Martinez-Miller, Brian Matlaga, Kevin McVary, Michelle Yu, Kelly R. Pekala, Hermoon Worku, Kody M. Armann, Chandler Hudson, Toby Zhu, Jordan M. Hay, Valentina Grajales, Jathin Bandari, Benjamin J. Davies, Bruce L. Jacobs, David Miller, Avinash Maganty, Oluwaseun Orikogobo, Kelly Pekala, Paul Rusilko, Alexandr Pinkhasov, Adam Cole, Scott Wiener, Mark Arthur, David Kozminski, Kim Williams, Paul Feustel, Christopher Stark, Lawrence Keatin, Gary Siskin, Allen Herr, Charles Welliver, Hermoon Worku, Kelly Pekala, Olutiwa Akomolede, Kody Armann, Anup Shah, Valentina Grajales, Oluwaseun Orikogbo, Devin Rogers, Michelle Yu, Jathin Bandari, Benjamin Davies, Bruce Jacobs, Zafardjan Dalimov, Nicole Alavi-Dunn, Julia S. Yu, Jordan S. Levine, K. Kent Chevli, Nicole Alavi-Dunn, Zafardjan Dalimov, Ali Houjaij, Jeffrey Villanueva, Valentina Grajales, Marc Colaco, Omar Ayyash, Rajeev Chaudhry, Francis Schneck, Glenn Cannon, Janelle Fox, Jin Kyu (Justin) Kim, Armando Lorenzo, Lucshman Raveendran, Michael Chua, Jessica Ming, Walid Farhat, Martin Koyle, Daniel Pelzman, Omar Ayyash, Marc Colaco, Glenn Cannon, Lucshman Raveendran, Joana Dos Santos, Martha Pokarowski, Edyta Marcon, Reza Vali, Afsaneh Amirabadi, Dean Elterman, Richard Foty, Armando Lorenzo, Martin Koyle, Jeffrey Villanueva, Brian Kocack, Marc Colaco, Benjamin Pifer, Francis Schneck, Janelle Fox, Rajeev Chaudhry, Glenn Cannon, Valentina Grajales, Avinash Maganty, Jeffrey Villanueva, Francis Schneck, Glenn Cannon, Paul Rusilko, Rajeev Chaudhry, Jeffrey Villanueva, Benjamin Pifer, Marc Colaco, Valentina Grajales, Omar Ayyash, Rajeev Chaudhry, Francis Schneck, Glenn Cannon, Janelle Fox, Jin Kyu (Justin) Kim, Armando Lorenzo, Luschman Raveendran, Michael Chua, Jessica Ming, Walid Farhat, Martin Koyle, Alexander Koven, Fardod O’Kelly, Ali El-Ghazzaoui, Jacob Langer, David Levin, Aubie Diamond, Yisroel Goldstein, Ezriel Reichman, Martin Koyle, Marc Colaco, Jeffrey Villanueva, Francis Schneck, Glenn Cannon, Janelle Fox, Marc Peretti, Rajeev Chaudhry, Joshua White, Landan MacDonald, Matthew Lowe, Dawn MacLellan, Rodrigo Romao, Michael Ernst, Nicole Belko, Teresa Danforth, Ellen Lutnick, Kyle Waisanen, Kevin Pranikoff, Kathryn Scott, Priyanka Kancherla, Garrett Smith, Matthew Mason, Anthony Tracey, Shady Garas, David Grynspan, Trustin Domes, Melise Keays, Julia Yu, Nicole Alavi-Dunn, Zafardjan Dalimov, John Bodkin, Anup Shah, Avinash Maganty, Paul Rusilko, Laura Donnelly, Feustel Paul, Cangero Theodore, Barry Kogan, Ahmed Elsayed, Umar Iqbal, Zhe Jing, Lee Richstone, Andrew Wagner, Bertram Yuh, Juan Palou, Eric Kim, Alexandre Mottrie, Thomas Maatman, Morgan Roupret, Derya Balbay, Carl Wijburg, Koon Rha, Franco Gaboardi, Michael Stockle, Prokar Dasgupta, Muhammad Shamim Khan, Peter Wiklund, James Peabody, Jihad Kaouk, Mani Menon, Ahmed Hussein, Gurkamal Chatta, Khurshid Guru, Kevin Carnes, Ashar Ata, Theodore Cangero, Badar Mian, Ahmed Hussein, Ahmed Elsayed, Mohammad Durrani, Umar Iqbal, Eduardo Cortes Gomez, Zhe Jing, Joseph Cilento, Lucas Kanestrin, Sean Gibson, Michael Mostowy, Alexander Yunke, Bernadette Zumpano, Sena Arman, Prashant Singh, Tang Li, Liu Song, Gary Smith, Khurshid Guru, Valentina Grajales, Nathan Hale, Jonathan Yabes, Robert Turner, Mina Fam, Lindsay Sabik, Jeffrey Gingrich, Benjamin Davies, Bruce Jacobs, Jathin Bandari, Sandra Kim, Rodney Breau, Ranjeeta Mallick, Anil Kapoor, Bhindi Bimal, Alan So, Antonio Finelli, Simon Tanguay, Frederic Pouliot, Adrian Fairey, Luke Lavallée, Ranjena Maloni, Ricardo Rendon, Thomas Osinski, Timothy Campbell, Jacob Gantz, Benjamin Nelson, Changyong Feng, Edward Messing, Ahmed Elsayed, Zhe Jing, Umar Iqbal, Deniz Demirbas, Mohammad Durrani, Kristopher Atwood, Joseph Cilento, Zafardjan Dalimov, Jennifer Osei, Sean Gibson, Michael Mostowy, Amylisa Christophe, Ahmed Hussein, Khurshid Guru, Ahmed Elsayed, Sean Gibson, Umar Iqbal, Zhe Jing, Lee Richstone, Andrew Wagner, Bertram Yuh, Juan Palou, Ahmed Aboumohamed, Eric Kim, Alexandre Mottrie, Morgan Roupret, Ketan Badani, Derya Balbay, Carl Wijburg, John Kelly, Koon Rha, Franco Gaboardi, Michael Stockle, Prokar Dasgupta, Muhammad Shamim Khan, Vassilis Poulakis, Peter Wiklund, James Peabody, Jihad Kaouk, Mani Menon, Ahmed Hussein, Khurshid Guru, Michael Mostowy, Ahmed Elsayed, Sadat Ozair, Mohammad Durrani, Umar Iqbal, Jennifer Osei, Zhe Jing, Alexander Yunke, Joseph Cilento, Blanka Kozma, Shikha Shelat, Lucas Kanestrin, Ahmed Hussein, Khurshid Guru, Mofarej Al-Hogbani, Jérémie Duguay, Philippe Joubert, Ricardo Rendon, Nicolas Power, Martine Périgny, Paul Toren, Stewart Whalen, Ricardo A. Rendon, David G. Bell, Morgan Macdonald, Jon Duplisea, Ashley R. Cox, Gregory G. Bailly, Ross Mason, Zafardjan Dalimov, Ahmed Elsayed, Umar Iqbal, Ahmed Hussein, Khurshid Guru, Ahmed Elsayed, Umar Iqbal, Zhe Jing, Jennifer Osei, Lee Richstone, Andrew Wagner, Bertram Yuh, Juan Palou, Eric Kim, Alex Mottrie, Derya Balbay, Carl Wijburg, Morgan Roupret, Ketan Badani, Franco Gaboardi, Michael Stockle, Prokar Dasgupta, Muhammad Shamim Khan, Peter Wiklund, Jihad Kaouk, James Peabody, Mani Menon, Ahmed Hussein, Khurshid Guru, Ahmed Elsayed, Amir Khan, Zhe Jing, Umar Iqbal, Jennifer Osei, Lee Richstone, Andrew Wagner, Bertram Yuh, Juan Palou, Eric Kim, Alexandre Mottrie, Thomas Maatman, Morgan Roupret, Ketan Badani, Derya Balbay, Ahmed Aboumohamed, Franco Gaboardi, Michael Stockle, Prokar Dasgupta, Muhammad Shamim Khan, Peter Wiklund, Jihad Kaouk, James Peabody, Mani Menon, Ahmed Hussein, Khurshid Guru, Carl Wijburg, Jennifer Osei, Ahmed Elsayed, Umar Iqbal, Zhe Jing, Naif Aldhaam, Mohammad Durrani, Bernadette Zumpano, Melissa Hopkins, Shikha Shelat, Joseph Ci lento, Amanda Pasquini, Zafardjan Dalimov, Sena Arman, Ahmed Hussein, Khurshid Guru, Valentina Grajales, Anup Shah, Kelly Pekala, Zhaojun Sun, Kirsten Eom, Benjamin Davies, Lindsay Sabik, Bruce Jacobs, Kadeen Forrest, Kathryn Scott, Rakesh Khanna, Shreyas Gandhi, Alex Koziarz, Jason Lee, John Perna, Rakesh Khanna, Kelly Pekala, Anup Shah, Valentina Grajales, Zhaojun Sun, Kirsten Eom, Benjamin Davies, Jie Li, Bruce Jacobs, Lindsay Sabik, Stephanie Gleicher, Natasha Ginzburg, Timothy Byler, James Ross, Humberto Vigil, Conrad Maciejewski, Blayne Welk, Ranjeeta Mallik, Rodney Breau, Duane Hickling, Chloe Shenk, Fei Lian, Darren Gemoets, Gillian Wolff, Kathryn Scott, Alexandr Pinkhasov, Elizabeth Ferry, Chris Bitcon, Ashley Cox, Kyle Waisanen, Adam Russon, Kevin Pranikoff, Ronald Swerdloff, Christina Wang, Marc Gittelman, Jed Kaminetsky, David Albala, James Longstreth, Robert Dudley, David-Dan Nguyen, Maya Marchese, Eugene B. Cone, Marco Paciotti, Shehzad Basaria, Naeem Bhojani, Quoc-Dien Trinh, Matthew Beamer, J. Curtis Nickel, Sergey Kravchick, Stephanie Gleicher, Timothy Byler, David Sikule, Charles Welliver, Alessia Di Carlo, Michael Leveridge, Thomas McGregor, Mark Arthur, Charles Welliver, Alexis Steinmetz, Ronald Rabinowitz, Zafardjan Dalimov, Jordan S. Levine, Julia S. Yu, Nicole Alavi-Dunn, K. Kent Chevli, Uday Mann, Amanda Eng, Rachel Wong, Zack Li, Ruben Blachman-Braun, Premal Patel, Jordan Levine, Zafardjan Dalimov, Julia Yu, Jinwei Hu, Teresa Danforth, Zafardjan Dalimov, Julia S. Yu, Jordan S. Levine, K. Kent Chevli, Rachel Melnyk, Patrick Saba, Tyler Holler, Prabhakar Mithal, Philip Rappold, Guan Wu, Jimena Cubillos, Hani Rashid, Jean Joseph, Ahmed Ghazi, David-Dan Nguyen, Kevin C. Zorn, Dean S. Elterman, Naeem Bhojani, Somayeh Shafiei, Ahmed Elsayed, Ahmed Hussein, Khurshid Guru, David-Dan Nguyen, Marco Paciotti, Quoc-Dien Trinh, Matthew Mossanen, David-Dan Nguyen, Dean Elterman, Kevin C. Zorn, Naeem Bhojani, Michael Hughes, Dominic Labella, Scott Wiener, Thomas Sanford, Avril Lusty, Isabelle Raîche, Michael Witthaus, Patrick Saba, Rachel Melnyk, Divya Ajay, Gareth Warren, Ricardo Munarriz, Ahmed Ghazi, Thomas Osinski, Rachel Melnyk, Tyler Holler, Janis Intoy, Katherine Cameron, Susan Greenman, Patrick Saba, Richard Grinstead, David Lee, Rajat Jain, Ashwani Sharma, Michele Rucci, Ahmed Ghazi, Jeannette Johnstone, Adam Gabara, Naji Touma, David Kozminski, Barry Kogan, Uday Mann, Jasmir G. Nayak, Premal Patel, Avril Lusty, Isabelle Raîche, Gregory Hosier, Thomas McGregor, Darren Beiko, Gregory Tasian, Christopher Booth, Marlo Whitehead, D. Robert Siemens, Chinmayee Katragadda, Alexis Steinmetz, Alexander Cranwell, Rajat Jain, Avinash Maganty, Allan Wolfson, Pamela Burrows, Ziya Kirkali, Andrew Meltzer, Stephen Jackman, David-Dan Nguyen, Jack W. Luo, Xing H. Lu, Jonathan R.Z. Lim, Kymora B. Scotland, Seth K. Bechis, Roger L. Sur, Stephen Y. Nakada, Jodi A. Antonelli, Necole M. Streeper, Sri Sivalingam, Davis P. Viprakasit, Timothy D. Averch, Jaime Landman, Thomas Chi, Vernon M. Pais, Vincent G. Bird, Sero Andonian, Noah E. Canvasser, Jonathan D. Harper, Ben H. Chew, Kristina L. Penniston, Naeem Bhojani, Mohammad Mohaghegh, Sarvesh Ramlochun, Colton Gibb, Francis Dinoy, Akhiazar Sabir, Danny Mann, Brian Peters, Connor Policastro, Garrett Smith, Mauro Dispagna, Scott Wiener, Brett Teplitz, Kit Yuen, Jacob Gantz, Prabhakar Mithal, Rajat Jain, Youshan Ding, Jacob Davidson, Ernest Chan, Jennifer Bjazevic, Guido Filler, Sumit Dave, Zhan Tao (Peter) Wang, Kody Armann, Kelly Pekala, Avinash Maganty, Michelle Yu, Jathin Bandari, Benjamin Davies, Bruce Jacobs, David M. Albala, Michael Donovan, Mikkel Noerholm, Vasisht Tadigotla, Sonia Kumar, Phillipp Torkler, Grannum Sant, Jason Alter, Johan Skog, Thomas Osinski, Kim Solomon, Anthony Mirabella, Jonathan Bloom, Thomas Frye, Gary Hollenberg, Eric Weinberg, Ronald Tutrone, David Albala, Michael Donovan, Phillipp Torkler, Vasisht Tadigotla, Mikkel Noerholm, Johan Skog, James McKiernan, James Mohler, Jennifer Cullen, Julie Lynch, Eric Klein, Stephen Van Den Eeden, Peter Carroll, Dejan Knezevic, Thomas Farrington, Jeffrey Lawrence, Ruixiao Lu, David M. Albala, Michael Donovan, Mikkel Noerholm, Vasisht Tadigotla, Sonia Kumar, Phillipp Torkler, Grannum Sant, Jason Alter, Johan Skog, Dominik Deniffel, Emmanuel Salinas, Marc Ientilucci, Andrew Evans, Neil Fleshner, Sangeet Ghai, Robert J. Hamilton, Ants Toi, Theodorus van der Kwast, Alexandre Zlotta, Antonio Finelli, Masoom Haider, Nathan Perlis, Judd Moul, Stuart Atkinson, Deborah Boldt-Houle, Richard Harris, Marie-Hélène Guertin, Karine Robitaille, Jean-François Pelletier, Molière Nguile Makao, Helene Hovington, Caroline Léger, Yves Fradet, Arnaud Marien, Frederic Pouliot, Louis Lacombe, Rabi Tiguert, Yves Caumartin, Thierry Dujardin, Paul Toren, Michele Lodde, Étienne Racine, Dominique Trudel, Martine Périgny, Thierry Duchesne, Josée Savard, Pierre Julien, Isabelle Bairati, Vincent Fradet, Adel Arezki, Iman Sadri, Ahmed S. Zakaria, Félix Couture, David-Dan Nguyen, Pierre Karakiewicz, Kevin C. Zorn, Adam Sharbaugh, Ronald Benoit, Ryan Smith, Christopher Houser, Sushil Beriwal, Hanane Moussa, Lamoussa Diabaté, Karine Robitaille, Laurence Bettan, Molière Nguile-Makao, Hélène Hovington, Fred Saad, Michel Carmel, Armen Aprikian, BIOCaPPE Network, Benoit Lamarche, Pierre Julien, Yves Fradet, Vincent Fradet, Samuel Fradet, Karine Robitaille, Jean-François Pelletier, Narcisse Singbo, Louis Lacombe, Frédéric Pouliot, Paul Toren, Yves Fradet, Michele Lodde, Rabi Tiguert, Thierry Dujardin, Josée Savard, Isabelle Bairati, Vincent Fradet, Roxane Tourigny, Hanane Moussa, Karine Robitaille, Fred Saad, Michel Carmel, Armen Aprikian, Yves Fradet, BIOCaPPE-GRéPEC Network, Vincent Fradet, Adam Sharbaugh, Ronald Benoit, Joshua Rodriguez-Lopez, Ankur Patel, Sushil Beriwal, Ryan Smith, David Albala, John Bennett, Tamer Aboushwareb, Natalie Lau, Melissa Stoppler, Aaron Katz, James McKiernan, David Albala, Ronald Tutrone, Michael Donovan, Phillipp Torkler, Mikkel Noerholm, Jason Alter, Johan Skog, Joshua White, Gabriela Ilie, Greg Bailly, David Bell, Robert Rutledege, Charlie Gillis, Thomas Southall, Michelle Anderson, Jennifer Young, Richard Hewitt, Matthew Andrews, Garrett Smith, Stephanie Gleicher, Joseph Jacob, Gennady Bratslavsky, Timothy Byler, Jason Alter, David Albala, Michael Donovan, Phillipp Torkler, Mikkel Noerholm, Johan Skog,

Can Urol Assoc J (Canadian Urological Association journal = Journal de l'Association des urologues du Canada)
[2020, 14(9 Suppl 3):S169-S232]

Cited: 0 times

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A New Oral Testosterone Undecanoate Formulation Restores Testosterone to Normal Concentrations in Hypogonadal Men.

Ronald S Swerdloff, Christina Wang, William B White, Jed Kaminetsky, Marc C Gittelman, James A Longstreth, Robert E Dudley, Theodore M Danoff,

<h4>Context</h4>A novel formulation of oral testosterone (T) undecanoate (TU) was evaluated in a phase 3 clinical trial.<h4>Objective</h4>Determine efficacy, short-term safety, and alignment of new oral TU formulation with current US approval standards for T replacement therapy.<h4>Design</h4>Randomized, active-controlled, open-label study.<h4>Setting and patients</h4>Academic and private clinical practice sites; enrolled patients were clinically ... Read more >>

J Clin Endocrinol Metab (The Journal of clinical endocrinology and metabolism)
[2020, 105(8):]

Cited: 2 times

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18F-Fluciclovine Positron Emission Tomography in Men With Biochemical Recurrence of Prostate Cancer After Radical Prostatectomy and Planning to Undergo Salvage Radiation Therapy: Results from LOCATE.

Abhishek A Solanki, Bital Savir-Baruch, Stanley L Liauw, Jeff Michalski, Jonathan D Tward, Neha Vapiwala, Eugene J Teoh, ,

PURPOSE:Conventional imaging rarely localizes the site(s) of prostate cancer recurrence in patients undergoing evaluation for salvage radiation therapy (sRT) after radical prostatectomy (RP). LOCATE (NCT02680041) was a prospective, multicenter study investigating the impact of 18F-fluciclovine positron emission tomography and computed tomography (PET/CT) on the management of patients with biochemical recurrence ... Read more >>

Pract Radiat Oncol (Practical radiation oncology)
[2020, 10(5):354-362]

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SAT-052 A Novel Oral Testosterone Therapy (TLANDO) Safely Restores Testosterone to Eugonadal Levels with Fixed Dose Treatment

Anthony DelConte, Mahesh V Patel, Kongnara Papangkorn, Nachiappan Chidambaram, Benjamin J Bruno, Kilyoung Kim, Joel Frank, Mohit Khera, Martin Miner, Jed Kaminetsky, Linda Vignozzi, Irwin Goldstein,

Abstract Most testosterone (T) replacement therapy (TRT) products have relied on dose titration to achieve eugonadal levels. However, dose titration in clinical practice can be time-consuming, expensive, and subject to errors. TLANDO (LPCN 1021) is a novel oral testosterone undecanoate (TU) product absorbed via the intestinal lymphatic pathway. A previous ... Read more >>

J Endocr Soc (Journal of the Endocrine Society)
[2020, 4(Suppl 1):]

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Safety of a New Subcutaneous Testosterone Enanthate Auto-Injector: Results of a 26-Week Study.

Marc Gittelman, Jonathan S Jaffe, Jed C Kaminetsky,

INTRODUCTION: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 ... Read more >>

J Sex Med (The journal of sexual medicine)
[2019, 16(11):1741-1748]

Cited: 3 times

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A 52-Week Study of Dose Adjusted Subcutaneous Testosterone Enanthate in Oil Self-Administered via Disposable Auto-Injector.

Jed C Kaminetsky, Andrew McCullough, Kathleen Hwang, Jonathan S Jaffe, Christina Wang, Ronald S Swerdloff,

<h4>Purpose</h4>In this open label, single arm, dose blinded, 52-week registration phase study we evaluated the efficacy and safety of a subcutaneous testosterone enanthate auto-injector administered weekly to men with hypogonadism.<h4>Materials and methods</h4>A total of 150 patients were initiated on a 75 mg subcutaneous testosterone enanthate auto-injector self-administered weekly. Dose adjustments ... Read more >>

J Urol (The Journal of urology)
[2019, 201(3):587-594]

Cited: 5 times

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The Impact of Positron Emission Tomography with 18F-Fluciclovine on the Treatment of Biochemical Recurrence of Prostate Cancer: Results from the LOCATE Trial.

Gerald L Andriole, Lale Kostakoglu, Albert Chau, Fenghai Duan, Umar Mahmood, David A Mankoff, David M Schuster, Barry A Siegel, ,

<h4>Purpose</h4>The prospective, multicenter LOCATE (F Fluciclovine [FACBC] PET/CT in Patients with Rising PSA after Initial Prostate Cancer Treatment) trial assessed the impact of positron emission tomography/computerized tomography with F-fluciclovine on treatment plans in patients with biochemical recurrence of prostate cancer after primary therapy with curative intent.<h4>Materials and methods</h4>Men who had ... Read more >>

J Urol (The Journal of urology)
[2019, 201(2):322-331]

Cited: 14 times

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Summative Usability Evaluation of the SCTE-AI Device: A Novel Prefilled Autoinjector for Subcutaneous Testosterone Administration.

Samir Arora, Betsy Moclair, Kyle Murphy, Jonathan S Jaffe, Jed C Kaminetsky,

<h4>Background</h4>The subcutaneous testosterone enanthate (TE) autoinjector (SCTE-AI) is a single-use, pre-filled, disposable autoinjector intended for testosterone (T) self-administration in adult males with T deficiency.<h4>Aim</h4>To evaluate the usability of the market configuration of the SCTE-AI, including packaging and instructions for use (IFU), in order to identify and mitigate any preventable patterns ... Read more >>

J Sex Med (The journal of sexual medicine)
[2018, 15(12):1707-1715]

Cited: 0 times

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Efficacy and Safety of SER120 Nasal Spray in Patients with Nocturia: Pooled Analysis of 2 Randomized, Double-Blind, Placebo Controlled, Phase 3 Trials.

Jed Kaminetsky, Seymour Fein, Roger Dmochowski, Scott MacDiarmid, Steven Abrams, Maria Cheng, Alan Wein,

<h4>Purpose</h4>SER120 desmopressin intranasal spray is the first U.S. Food and Drug Administration approved pharmacotherapy for nocturia. We evaluated its efficacy and safety in 2 randomized, double-blind, placebo controlled studies, DB3 and DB4.<h4>Materials and methods</h4>A total of 1,333 intent to treat patients 50 years old or older with 2.16 or more ... Read more >>

J Urol (The Journal of urology)
[2018, 200(3):604-611]

Cited: 6 times

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Fexapotide triflutate: results of long-term safety and efficacy trials of a novel injectable therapy for symptomatic prostate enlargement.

Neal Shore, Ronald Tutrone, Mitchell Efros, Mohamed Bidair, Barton Wachs, Susan Kalota, Sheldon Freedman, James Bailen, Richard Levin, Stephen Richardson, Jed Kaminetsky, Jeffrey Snyder, Barry Shepard, Kenneth Goldberg, Alan Hay, Steven Gange, Ivan Grunberger,

PURPOSE:These studies were undertaken to determine if fexapotide triflutate 2.5 mg transrectal injectable (FT) has significant long-term (LT) safety and efficacy for the treatment of benign prostatic hyperplasia (BPH). METHODS:Two placebo controlled double-blind randomized parallel group trials with 995 BPH patients at 72 sites treated 3:2 FT:placebo, with open-label FT crossover ... Read more >>

World J Urol (World journal of urology)
[2018, 36(5):801-809]

Cited: 5 times

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Multicenter Clinical Evaluation of the Alere i Respiratory Syncytial Virus Isothermal Nucleic Acid Amplification Assay.

Ferdaus Hassan, Lindsay M Hays, Aleta Bonner, Bradley J Bradford, Ruffin Franklin, Phyllis Hendry, Jed Kaminetsky, Michael Vaughn, Kristin Cieslak, Mary E Moffatt, Rangaraj Selvarangan,

The Alere i respiratory syncytial virus (RSV) assay is an isothermal nucleic acid amplification test capable of detecting RSV directly from respiratory specimens, with results being available in ≤13 min after test initiation. The objective of this study was to evaluate the performance characteristics of the Alere i RSV assay ... Read more >>

J Clin Microbiol (Journal of clinical microbiology)
[2018, 56(3):]

Cited: 3 times

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Quality of erections by age group in men with erectile dysfunction.

Jed C Kaminetsky, Vera Stecher, Li-Jung Tseng,

<h4>Aims</h4>The aim of this study was to assess erection quality with sildenafil vs placebo and adverse events (AEs) according to age (≤45, 46-55 and ≥56 years) in 997 men with erectile dysfunction (ED) using pooled data from four randomized, double-blind, placebo-controlled, flexible-dose trials.<h4>Methods</h4>The trials included 6- to 10-week treatment periods. The ... Read more >>

Int J Clin Pract (International journal of clinical practice)
[2017, 71(10):]

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Performance of a palladium-103 line source for prostate brachytherapy implants: A Phase I trial.

Richard Stock, David Beyer, Jed Kaminetsky, William Ge,

<h4>Purpose</h4>To evaluate the use of a polymer-encapsulated palladium-103 (<sup>103</sup> Pd) source with a unique linear radioactive distribution in prostate brachytherapy. This feasibility study assessed dosimetry, ease and efficiency of use, and side effects. The number of needles required for adequate coverage was the primary end point.<h4>Methods and materials</h4>CivaString <sup>103</sup> Pd ... Read more >>

Brachytherapy (Brachytherapy)
[2017, 16(5):1007-1012]

Cited: 1 time

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Convective Thermal Therapy: Durable 2-Year Results of Randomized Controlled and Prospective Crossover Studies for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia.

Claus G Roehrborn, Steven N Gange, Marc C Gittelman, Kenneth A Goldberg, Kalpesh Patel, Neal D Shore, Richard M Levin, Michael Rousseau, J Randolf Beahrs, Jed Kaminetsky, Barrett E Cowan, Christopher H Cantrill, Lance A Mynderse, James C Ulchaker, Thayne R Larson, Christopher M Dixon, Kevin T McVary,

<h4>Purpose</h4>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.<h4>Materials and methods</h4>A total of 197 men at least 50 years old with I-PSS (International ... Read more >>

J Urol (The Journal of urology)
[2017, 197(6):1507-1516]

Cited: 18 times

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Response and Rebuttal to Editorial Commentary on "Erectile and Ejaculatory Function Preserved With Convective Water Vapor Energy Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: Randomized Controlled Study".

Kevin T McVary, Steven N Gange, Marc C Gittelman, Kenneth A Goldberg, Kalpesh Patel, Neal D Shore, Richard M Levin, Michael Rousseau, J Randolf Beahrs, Jed Kaminetsky, Barrett E Cowan, Christopher H Cantrill, Lance A Mynderse, James C Ulchaker, Thayne R Larson, Christopher M Dixon, Claus G Roehrborn,

J Sex Med (The journal of sexual medicine)
[2016, 13(6):936-937]

Cited: 0 times

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Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial.

Anita H Clayton, Stanley E Althof, Sheryl Kingsberg, Leonard R DeRogatis, Robin Kroll, Irwin Goldstein, Jed Kaminetsky, Carl Spana, Johna Lucas, Robert Jordan, David J Portman,

<h4>Aim</h4>Evaluate efficacy/safety of bremelanotide (BMT), a melanocortin-receptor-4 agonist, to treat female sexual dysfunctions in premenopausal women.<h4>Methods</h4>Patients randomized to receive placebo or BMT 0.75, 1.25 or 1.75 mg self-administered subcutaneously, as desired, over 12 weeks. Primary end point was change in satisfying sexual events/month. Secondary end points included total score changes ... Read more >>

Womens Health (Lond) (Women's health (London, England))
[2016, 12(3):325-337]

Cited: 18 times

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Erectile and Ejaculatory Function Preserved With Convective Water Vapor Energy Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: Randomized Controlled Study.

Kevin T McVary, Steven N Gange, Marc C Gittelman, Kenneth A Goldberg, Kalpesh Patel, Neal D Shore, Richard M Levin, Michael Rousseau, J Randolf Beahrs, Jed Kaminetsky, Barrett E Cowan, Christopher H Cantrill, Lance A Mynderse, James C Ulchaker, Thayne R Larson, Christopher M Dixon, Claus G Roehrborn,

<h4>Introduction</h4>Most surgical treatments for male lower urinary tract symptoms and benign prostatic hyperplasia affect erectile and ejaculatory functions negatively, leading to patient dissatisfaction.<h4>Aim</h4>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 ... Read more >>

J Sex Med (The journal of sexual medicine)
[2016, 13(6):924-933]

Cited: 22 times

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Efficacy and Safety of Sildenafil by Age in Men With Erectile Dysfunction.

Irwin Goldstein, Li-Jung Tseng, Dana Creanga, Vera Stecher, Jed C Kaminetsky,

<h4>Introduction</h4>Sildenafil, an oral phosphodiesterase type 5 inhibitor, has been extensively investigated for the treatment of erectile dysfunction in randomized controlled trials.<h4>Aim</h4>To assess the efficacy and safety of sildenafil vs placebo according to age subgroups (<65, 65-74, and ≥75 years) in 11,364 men with erectile dysfunction using pooled data from 48 randomized, ... Read more >>

J Sex Med (The journal of sexual medicine)
[2016, 13(5):852-859]

Cited: 11 times

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Durable Efficacy and Safety of Long-Term OnabotulinumtoxinA Treatment in Patients with Overactive Bladder Syndrome: Final Results of a 3.5-Year Study.

Victor W Nitti, David Ginsberg, Karl-Dietrich Sievert, David Sussman, Sidney Radomski, Peter Sand, Dirk De Ridder, Brenda Jenkins, Andrew Magyar, Christopher Chapple, ,

<h4>Purpose</h4>These are the final results of the prospective, multicenter, long-term (3.5-year) study of the efficacy/safety of onabotulinumtoxinA for overactive bladder syndrome.<h4>Materials and methods</h4>Patients who completed either of 2, 24-week phase 3 trials could enter a 3-year extension and continue treatment with onabotulinumtoxinA 100 U as needed to control overactive bladder ... Read more >>

J Urol (The Journal of urology)
[2016, 196(3):791-800]

Cited: 24 times

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Minimally Invasive Prostate Convective Water Vapor Energy Ablation: A Multicenter, Randomized, Controlled Study for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

Kevin T McVary, Steven N Gange, Marc C Gittelman, Kenneth A Goldberg, Kalpesh Patel, Neal D Shore, Richard M Levin, Michael Rousseau, J Randolf Beahrs, Jed Kaminetsky, Barrett E Cowan, Christopher H Cantrill, Lance A Mynderse, James C Ulchaker, Thayne R Larson, Christopher M Dixon, Claus G Roehrborn,

<h4>Purpose</h4>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.<h4>Materials and methods</h4>Men 50 years old or older with an International Prostate Symptom Score of 13 or greater, maximum flow rate ... Read more >>

J Urol (The Journal of urology)
[2016, 195(5):1529-1538]

Cited: 39 times

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Oral enclomiphene citrate raises testosterone and preserves sperm counts in obese hypogonadal men, unlike topical testosterone: restoration instead of replacement.

Edward D Kim, Andrew McCullough, Jed Kaminetsky,

OBJECTIVES:To determine the effects of daily oral doses of enclomiphene citrate compared with topical testosterone gel treatment on serum total testosterone (TT), luteinising hormone (LH), follicle-stimulating hormone (FSH), and sperm counts in men with secondary hypogonadism. PATIENTS AND METHODS:Two parallel randomised, double-blind, double-dummy, placebo-controlled, multicentre, phase III studies were undertaken ... Read more >>

BJU Int (BJU international)
[2016, 117(4):677-685]

Cited: 23 times

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