Submissions from 2022
Results of a phase 1, randomized, placebo controlled first-in-human trial of griffithsin formulated in a carrageenan vaginal gel, Natalia Teleshova, Marla J. Keller, José Fernández-Romero, Barbara Friedland, George W. Creasy, Marlena Gehret Plagianos, Laurie Ray, Patrick Barnable, Larisa Kizima, Aixa Rodriguez, Nadjet Cornejal, Claudia Melo, Gearoff Cruz Rodriguez, Sampurna Mukhopadhyay, Giulia Calenda, Shweta U. Sinkar, Thierry Bonnaire, Asa Wesenberg, Shimin Zhang, Kyle Kleinbeck, Kenneth Palmer, Mohcine Alami, Barry R. O'Keefe, Patrick Gillevet, Hong Hur, Yupu Liang, Gabriela Santone, Raina N. Fichorova, Tamara Kalir, and Thomas Zydowsky
Submissions from 2021
The effect of antiretroviral therapy for the treatment of human immunodeficiency virus (HIV)-1 in pregnancy on gestational weight gain, Naima T. Joseph, Glen A. Satten, Rachel E. Williams, Lisa Haddad, Denise J. Jamieson, Anandi N. Sheth, and Martina L. Badell
Contraception methods used among women with HIV starting antiretroviral therapy in a large United States clinical trial, 2009–2011, Anandi N. Sheth, Christine D. Angert, Lisa Haddad, C. Christina Mehta, and Susan E. Cohn
Marijuana, opioid, and alcohol use among pregnant and postpartum individuals living with HIV in the US, Lynn M. Yee, Deborah Kacanek, Chase Brightwell, Lisa Haddad, Jennifer Jao, Kathleen M. Powis, Tzy-Jyun Yao, Emily Barr, Carly Broadwell, Suzanne Siminski, George R. Seage, Ellen G. Chadwick, and Pediatric HIV/AIDS Cohort Study (PHACS)
Marijuana, opioid, and alcohol use among pregnant and postpartum individuals living with HIV in the US, Lynn M. Yee, Deborah Kacanek, Chase Brightwell, Lisa Haddad, Jennifer Jao, Kathleen M. Powis, Tzy-Jyun Yao, Emily Barr, Carly Broadwell, Suzanne Siminski, George R. Seage, Ellen G. Chadwick, and Pediatric HIV/AIDS Cohort Study (PHACS)
Submissions from 2020
No-flip ShangRing circumcision in 10-12 year old boys: Results from randomized clinical trials in Kenya, Omar Al Hussein Alawamlh, Quentin Awori, Mark Barone, Soo-Jeong Kim, Marc Goldstein, Philip S. Li, and Richard K. Lee
Dose-finding study of a 90-day contraceptive vaginal ring releasing estradiol and segesterone acetate, Melissa J. Chen, Mitchell Creinin, David K. Turok, David F. Archer, Kurt T. Barnhart, Carolyn Westhoff, Michael A. Thomas, Jeffrey T. Jensen, Bruce Variano, Régine Sitruk-Ware, Anita Shanker, Jill Long, and Diana Blithe
Progesterone vaginal ring as a new contraceptive option for lactating mothers: Evidence from a multicenter non-randomized comparative clinical trial in India, Malabika Roy, Avishek Hazra, Ruth Merkatz, Marlena Gehret Plagianos, Mohcine Alami, L.N. Gaur, Kumudha Aruldas, Heather Sussman, Bruce Variano, and Régine Sitruk-Ware
Chagas disease screening using point-of-care testing in an at-risk obstetric population, Lindsey E. Zamora, Federico Palacio, Debra S. Kozlowski, Kamini Doraivelu, Carolynn M. Dude, Denise J. Jamieson, and Lisa Haddad
Submissions from 2019
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Study to evaluate the safety of griffithsin in a carrageenan gel in healthy women, Population Council
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
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
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
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
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
A fresh look at an old problem, Thomas Zydowsky
Submissions from 2016
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
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
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
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
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
Risk of pregnancy in breastfeeding mothers: Role of the progesterone vaginal ring on birth spacing, Régine Sitruk-Ware, Saumya RamaRao, Ruth Merkatz, and John Townsend
In vitro exposure to PC-1005 and cervicovaginal lavage fluid from women vaginally administered PC-1005 inhibits 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
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
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
Safety, pharmacokinetics and acceptability of PC-1005 for vaginal use, Population Council
Submissions from 2014
First-in-human safety and pharmacokinetics (PK) of a MIV-150/zinc acetate/carrageenan gel (PC-1005), George W. Creasy, Craig Hoesley, Barbara Friedland, Shimin Zhang, Marlena Gehret Plagianos, Kyle Kleinbeck, Keith Levendosky, José Fernández-Romero, and Thomas Zydowsky
A randomized study on pharmacodynamic effects of vaginal rings delivering the progesterone receptor modulator ulipristal acetate: Research for a novel estrogen-free, method of contraception, Yong-mei Huang, Jeffrey T. Jensen, Vivian Brache, Leila Cochen, Alistair Williams, Marie-José Miranda, Horacio B. Croxatto, Narender Kumar, Heather Sussman, Elena Hoskin, Marlena Gehret Plagianos, Kevin Roberts, Ruth Merkatz, Diana Blithe, and Régine Sitruk-Ware
Acceptability of a transdermal gel-based male hormonal contraceptive in a randomized controlled trial, Mara Y. Roth, Grace Shih, Niloufar Ilani, Christina Wang, Stephanie T. Page, William J. Bremner, Ronald S. Swerdloff, Régine Sitruk-Ware, Diana Blithe, and John K. Amory
Submissions from 2013
Safety and adherence of a non-medicated intravaginal ring (IVR) (MTN-005), Population Council
Characteristics and metabolic effects of estrogen and progestins contained in oral contraceptive pills, Régine Sitruk-Ware and Anita Nath
Submissions from 2012
Vasectomy reversal in humans, Aaron M. Bernie, E. Charles Osterberg, Peter J. Stahl, Ranjith Ramasamy, and Marc Goldstein
Effects of a novel estrogen-free, progesterone receptor modulator-contraceptive vaginal ring on inhibition of ovulation, bleeding patterns and endometrium in normal women, Vivian Brache; Régine Sitruk-Ware; A. Williams; Diana Blithe; Horacio B. Croxatto; Narender Kumar; Sushma Kumar; Yun-yen Tsong; Irving Sivin; Anita Nath; Heather Sussman; Leila Cochon; Marie-José Miranda; Veronica Reyes; Anibal Faundes; and Daniel R. Mishell, Jr.
Postpartum unintended pregnancy and contraception practice among rural-to-urban migrant women in Shanghai, Yong-mei Huang, Ruth Merkatz, Jian-Zhong Kang, Kevin Roberts, Xiao-Yu Hu, Francis Di Donato, Régine Sitruk-Ware, and Li-nan Cheng
A new combination of testosterone and nestorone transdermal gels for male hormonal contraception, Niloufar Ilani, Mara Y. Roth, John K. Amory, Ronald S. Swerdloff, Clint Dart, Stephanie T. Page, William J. Bremner, Régine Sitruk-Ware, Narender Kumar, Diana Blithe, and Christina Wang
Progesterone receptors: A key for neuroprotection in experimental stroke, Ailing Liu, Isabelle Margaill, Shaodong Zhang, Florencia Labombarda, Berard Coqueran, Brigitte Delespierre, Philippe Liere, Catherine Marchand-Leroux, Bert W. O'Malley, John P. Lydon, Alejandro De Nicola, Régine Sitruk-Ware, Claudia Mattern, Michel Plotkine, Michael Schumacher, and Rachida Guennoun
Increased impact of a contraceptive vaginal ring with ethinyl estradiol and nestorone on C-reactive protein, Mandana Rad, Jacobus Burggraaf, Régine Sitruk-Ware, Marieke L. de Kam, Adam F. Cohen, and Cornelius Kluft
Submissions from 2011
Hormonal influences in multiple sclerosis: New therapeutic benefits for steroids, Martine El-Etr, Abdel M. Ghoumari, Régine Sitruk-Ware, and Michael Schumacher
Validation of a dye stain assay for vaginally inserted hydroxyethylcellulose-filled microbicide applicators, Lauren L. Katzen, José Fernández-Romero, Avina Sarna, Kailapuri G. Murugavel, Daniel Gawarecki, Thomas Zydowsky, and Barbara Mensch
Submissions from 2010
Clinically relevant progestins regulate neurogenic and neuroprotective responses in vitro and in vivo, Lifei Liu, Liqin Zhao, Hongyun She, Shuhua Chen, Jun Ming Wang, Charisse Wong, Kelsey McClure, Régine Sitruk-Ware, and Roberta Diaz Brinton
Progesterone vaginal ring for contraceptive use during lactation, Anita Nath and Régine Sitruk-Ware
Endometrial effect of progesterone delivered by vaginal rings in estrogen-treated postmenopausal women, Gabriela Noe; Régine Sitruk-Ware; Fernando Zegers-Hochschild; Bruce Variano; Juan Carlos Montero; P. Arriagada; A. Li; Frank Z. Stanczyk; J.C. Felix; Daniel R. Mishell, Jr.; and Horacio B. Croxatto
No-needle local anesthesia for adult male circumcision, Yifeng Peng, Puneet Masson, Philip S. Li, Yue Chang, Long Tian, Richard Lee, Howard H. Kim, David C. Sokal, and Marc Goldstein
Submissions from 1992
The Copper T 380 Intrauterine Device: A Summary of Scientific Data, Irving Sivin, Forrest Greenslade, Frederick H. Schmidt, and Sandra N. Waldman