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Submissions from 2019

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Combined Nestorone–testosterone gel suppresses serum gonadotropins to concentrations associated with effective hormonal contraception in men, Bradley D. Anawalt, Mara Y. Roth, Jonas Ceponis, Vijaya Surampadi, John K. Amory, Ronald S. Swerdloff, Peter Y. Liu, Clint Dart, William J. Bremner, Régine Sitruk-Ware, Narender Kumar, Diana Blithe, Stephanie T. Page, and Christina Wang

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Efficacy of the 1-year (13-cycle) segesterone acetate and ethinylestradiol contraceptive vaginal system: Results of two multicentre, open-label, single-arm, phase 3 trials, David F. Archer, Ruth Merkatz, Luis Bahamondes, Carolyn Westhoff, Philip Darney, Dan Apter, Jeffrey T. Jensen, Vivian Brache, Anita L. Nelson, Erika Banks, György Bártfai, David J. Portman, Marlena Gehret Plagianos, Clint Dart, Narender Kumar, George W. Creasy, Régine Sitruk-Ware, and Diana Blithe

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Use of topical versus injectable anaesthesia for ShangRing circumcisions in men and boys in Kenya: Results from a randomized controlled trial, Quentin Awori, Philip S. Li, Richard K. Lee, Daniel Ouma, Millicent Oundo, Mukhaye Barasa, Nereah Obura, David Mwamkita, Raymond Otieno Simba, Jairus Oketch, Nixon Nyangweso, Mary N. Maina, Nicholas Kiswi, Michael Kirui, Betty Chirchir, Marc Goldstein, and Mark Barone

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In vitro release testing methods for drug-releasing vaginal rings, Peter Boyd, Bruce Variano, Patrick Spence, Clare F. McCoy, Diarmaid J. Murphy, Yahya H. Dallal Bashi, and R. Karl Malcolm

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Segesterone acetate/ethinyl estradiol 12-month contraceptive vaginal system safety evaluation, Kristina Gemzell-Danielsson, Régine Sitruk-Ware, Mitchell Creinin, Michael Thomas, Kurt T. Barnhart, George W. Creasy, Heather Sussman, Mohcine Alami, Anne E. Burke, Edith Weisberg, Ian S. Fraser, Marie-José Miranda, Melissa Gilliam, James Liu, Bruce R. Carr, Marlena Gehret Plagianos, Kevin Roberts, and Diana Blithe

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Efficacy and safety of a 1-year segesterone acetate and ethinyl estradiol contraceptive vaginal system, Ruth Merkatz, Maureen Magnani, Heather Sussman, George W. Creasy, and Régine Sitruk-Ware

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Post-use ring weight and residual drug content as potential objective measures of user adherence to a contraceptive progesterone vaginal ring, Diarmaid J. Murphy, Clare F. McCoy, Marlena Gehret Plagianos, Saumya RamaRao, Ruth Merkatz, Heather Clark, Peter Boyd, Bruce Variano, and R. Karl Malcolm

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Rollout of ShangRing circumcision with active surveillance for adverse events and monitoring for uptake in Kenya, Elijah Odoyo-June, Nandi Owuor, Saida Kassim, Stephanie Davis, Kawango Agot, Kennedy Serrem, George Otieno, Quentin Awori, Jonas Hines, Carlos Toledo, Catey Laube, Christine Kisia, Appolonia Aoko, Vincent Ojiambo, Zebedee Mwandi, Ambrose Juma, and Bartilol Kigen

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Bone turnover markers in women participating in a dose-finding trial of a contraceptive vaginal ring releasing Nestorone and estradiol, Molly Tiedeken, Carolyn Westhoff, Adi Cohen, Serge Cremers, Régine Sitruk-Ware, Diana Blithe, and The NICHD Contraceptive Trials Network Vaginal Ring Group

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Beyond contraception and hormone replacement therapy: Advancing Nestorone to a neuroprotective drug in the clinic, Julian P. Tuazon, Régine Sitruk-Ware, and Cesario V. Borlongan

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Bleeding profile associated with 1-year use of the segesterone acetate/ethinyl estradiol contraceptive vaginal system: Pooled analysis from phase 3 trials, Carolina Sales Vieira, Ian S. Fraser, Marlena Gehret Plagianos, Anne E. Burke, Carolyn Westhoff, Jeffrey T. Jensen, Vivian Brache, Luis Bahamondes, Ruth Merkatz, Régine Sitruk-Ware, and Diana Blithe

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Preventing secondary exposure to women from men applying a novel Nestorone/testosterone contraceptive gel, F. Yuen, S. Wu, A. Thirumalai, Ronald S. Swerdloff, Stephanie T. Page, Peter Y. Liu, Clint Dart, H. Wu, Diana Blithe, Régine Sitruk-Ware, J. Long, F. Bai, L. Hull, William J. Bremner, Bradley D. Anawalt, and Christina Wang

Submissions from 2018

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Simplifying the ShangRing technique for circumcision in boys and men: Use of the no-flip technique with randomization to removal at 7 days versus spontaneous detachment, Mark Barone, Philip S. Li, Richard K. Lee, Daniel Ouma, Millicent Oundo, Mukhaye Barasa, Jairus Oketch, Patrick Otiende, Nixon Nyangweso, Mary N. Maina, Nicholas Kiswi, Betty Chirchir, Marc Goldstein, and Quentin Awori

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Safety of tubal occlusion by minilaparotomy provided by trained clinical officers versus assistant medical officers in Tanzania: A randomized, controlled, noninferiority trial, Mark Barone, Zuhura Mbuguni, Japhet Ominde Achola, Annette Almeida, Carmela Cordero, Joseph Kanama, Adriana Marquina, Projestine Muganyizi, Jamilla Mwanga, Daniel Ouma, Caitlin S. Shannon, and Leopold Tibyehabwa

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Vaginal progesterone is as effective as cervical cerclage to prevent preterm birth in women with a singleton gestation, previous spontaneous preterm birth, and a short cervix: Updated indirect comparison meta-analysis, Agustin Conde-Agudelo, Roberto Romero, Eduardo Da Fonseca, John M. O'Brien, Elcin Cetingoz, George W. Creasy, Sonia S. Hassan, Offer Erez, Percy Pacora, and Kypros H. Nicolaides

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Continuous dosing of a novel contraceptive vaginal ring releasing Nestorone® and estradiol: Pharmacokinetics from a dose-finding study, Jeffrey T. Jensen, Alison E. Edelman, Beatrice A. Chen, D.F. Archer, Kurt T. Barnhart, M.A. Thomas, Anne E. Burke, Carolyn Westhoff, Livia Wan, Régine Sitruk-Ware, Narender Kumar, Bruce Variano, and Diana Blithe

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Characterization of molecular changes in endometrium associated with chronic use of progesterone receptor modulators: Ulipristal acetate versus mifepristone, Athilakshmi Kannan, A. Bhurke, Régine Sitruk-Ware, P.G. Lalitkumar, Kristina Gemzell-Danielsson, A. Williams, R.N. Taylor, Milan K. Bagchi, and Indrani C. Bagchi

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Solid state ^13C NMR spectroscopy provides direct evidence for reaction between ethinyl estradiol and a silicone elastomer vaginal ring drug delivery system, Clare F. McCoy, David C. Apperley, Bruce Variano, Heather Sussman, Dan Loeven, Peter Boyd, and R. Karl Malcolm

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Study to evaluate the safety of griffithsin in a carrageenan gel in healthy women, Population Council

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Effects of concurrent vaginal miconazole treatment on the absorption and exposure of Nestorone® (segesterone acetate) and ethinyl estradiol delivered from a contraceptive vaginal ring: A randomized, crossover drug–drug interaction study, Katharine B. Simmons, Narender Kumar, Marlena Gehret Plagianos, Kevin Roberts, Elena Hoskin, Leo Han, Mohcine Alami, George W. Creasy, Bruce Variano, and Ruth Merkatz

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Factors associated with non-adherence to instructions for using the Nestorone®/ethinyl estradiol contraceptive vaginal ring, Bianca M. Stifani, Marlena Gehret Plagianos, Carolina Sales Vieira, and Ruth Merkatz

Submissions from 2017

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Nestorone® (NES) a novel progestin for non-oral contraception: Structure-activity relationships and brain metabolism studies, Narender Kumar, Jerome Fagart, Philippe Liere, Scott J. Mitchell, Alanah R. Knibb, Isabelle Petit-Topin, Marion Rame, Martine El-Etr, Michael Schumacher, Jeremy J. Lambert, Marie-Edith Rafestin-Oblin, and Régine Sitruk-Ware

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Factors predicting improper use of a woman-controlled long-acting reversible contraceptive: Results from the acceptability study of a novel contraceptive vaginal ring, Bianca M. Stifani, Marlena Gehret Plagianos, Carolina Sales Vieira, and Ruth Merkatz

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Impact of various progestins with or without transdermal testosterone on gonadotropin levels for non-invasive hormonal male contraception: A randomized clinical trial, Michael Zitzmann, Julia Rohayem, J. Raidt, Sabine Kliesch, Narender Kumar, and Régine Sitruk-Ware

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A fresh look at an old problem, Thomas Zydowsky

Submissions from 2016

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Impact on hepatic estrogen-sensitive proteins by a 1-year contraceptive vaginal ring delivering Nestorone® and ethinyl estradiol, David F. Archer, M.A. Thomas, Jacqueline Conard, Ruth Merkatz, George W. Creasy, Kevin Roberts, Marlena Gehret Plagianos, Diana Blithe, and Régine Sitruk-Ware

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Surgical outcomes of newly trained ShangRing circumcision providers, Quentin Awori, Richard K. Lee, Philip S. Li, Robert Zulu, Kawango Agot, Stephanie Combes, Raymond Otieno Simba, Catherine Hart, Jaim Jou Lai, Zude Zyambo, Marc Goldstein, Paul Feldblum, and Mark Barone

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Men's understanding of and experiences during the postcircumcision abstinence period: Results from a field study of ShangRing circumcision during routine clinical services in Kenya and Zambia, Mark Barone, Philip S. Li, Robert Zulu, Quentin Awori, Kawango Agot, Stephanie Combes, Raymond Otieno Simba, Richard K. Lee, Catherine Hart, Jaim Jou Lai, Zude Zyambo, Marc Goldstein, Paul Feldblum, and David C. Sokal

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A first-in-human trial of MIV-150 and zinc acetate co-formulated in a carrageenan gel: Safety, pharmacokinetics, acceptability, adherence and pharmacodynamics, Barbara Friedland, Craig Hoesley, Marlena Gehret Plagianos, Elena Hoskin, Shimin Zhang, Natalia Teleshova, Mohcine Alami, Lea Novak, Kyle Kleinbeck, Lauren L. Katzen, Thomas Zydowsky, José Fernández-Romero, and George W. Creasy

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Baseline predictors of high adherence to a coitally dependent microbicide gel based on an objective marker of use: Findings from the Carraguard Phase 3 Trial, Barbara Friedland, Marie Stoner, Michelle Chau, Marlena Gehret Plagianos, Sumentheran N. Govender, Neetha S. Morar, Lydia Altini, Stephanie Skoler-Karpoff, Khatija Ahmed, Gita Ramjee, Constance Monedi, Robin A. Maguire, and Pekka Lahteenmaki

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In vitro exposure to PC-1005 and cervicovaginal lavages from women vaginally administered PC-1005 inhibit HIV-1 and HSV-2 infection in human cervical mucosa, Guillermo Villegas, Giulia Calenda, Shimin Zhang, Olga Mizenina, Kyle Kleinbeck, Michael Cooney, Craig Hoesley, George W. Creasy, Barbara Friedland, José Fernández-Romero, Thomas Zydowsky, and Natalia Teleshova

Submissions from 2015

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A dose-finding, cross-over study to evaluate the effect of a Nestorone®/Estradiol transdermal gel delivery on ovulation suppression in normal ovulating women, Vivian Brache; Ruth Merkatz; Narender Kumar; Cristian Jesam Gaete; Heather Sussman; Elena Hoskin; Kevin Roberts; Mohcine Alami; DeShawn Taylor; Aidelis Jorge; Horacio B. Croxatto; Ellen Lorange; Daniel R. Mishell, Jr.; and Régine Sitruk-Ware

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Hormonal contraception and the risk of HIV acquisition: An individual participant data meta-analysis, Charles S. Morrison, Pai-lien Chen, Cynthia Kwok, Jared M. Baeten, Joelle Brown, Angela M. Cook, Lut Van Damme, Sinead Delany-Moretlwe, Suzanna C. Francis, Barbara Friedland, Richard J. Hayes, Renee Heffron, Saidi H. Kapiga, Quarraisha Abdool Karim, Stephanie Skoler-Karpoff, Rupert Kaul, R. Scott McClelland, Sheena McCormack, Nuala McGrath, Landon Myer, Helen Rees, Ariane van der Straten, Deborah Watson-Jones, Janneke van de Wijgert, Randy Stalter, and Nicola Low

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Safety, pharmacokinetics and acceptability of PC-1005 for vaginal use, Population Council

Submissions from 2013

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Safety and adherence of a non-medicated intravaginal ring (IVR) (MTN-005), Population Council