Phase 1 randomized trials to assess safety, pharmacokinetics, and vaginal bleeding associated with use of extended duration dapivirine and levonorgestrel vaginal rings.

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Title: Phase 1 randomized trials to assess safety, pharmacokinetics, and vaginal bleeding associated with use of extended duration dapivirine and levonorgestrel vaginal rings.
Authors: Achilles SL; Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America.; Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America., Kelly CW; Statistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Center, Seattle, Washington, United States of America., Hoesley CJ; University of Alabama at Birmingham Heersink School of Medicine, Birmingham, Alabama, United States of America., Blithe DL; National Institute of Child Health and Human Development, Contraceptive Development Program, DIPHR, NIH, Bethesda, Maryland, United States of America., Brown J; National Institute of Child Health and Human Development, Contraceptive Development Program, DIPHR, NIH, Bethesda, Maryland, United States of America., Richardson BA; Statistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Center, Seattle, Washington, United States of America.; Department of Biostatistics, University of Washington, Seattle, Washington, United States of America., Devlin B; International Partnership for Microbicides, Silver Spring, Maryland, United States of America., Hendrix CW; Department of Medicine, Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America., Poloyac SM; Department of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America., Marzinke MA; Department of Medicine, Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America., Gundacker H; Statistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Center, Seattle, Washington, United States of America., Singh D; Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America., Piper JM; National Institutes of Allergy and Infectious Disease, NIH, Bethesda, Maryland., Johnson S; FHI 360, Durham, North Carolina, United States of America., Steytler J; International Partnership for Microbicides, Silver Spring, Maryland, United States of America., Chen BA; Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America.; Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America.
Corporate Authors: MTN-030/IPM 041 and MTN-044/IPM 053/CCN019 Protocol Teams for the Microbicide Trials Network and the Contraceptive Clinical Trials Network
Source: PloS one [PLoS One] 2024 Jun 05; Vol. 19 (6), pp. e0304552. Date of Electronic Publication: 2024 Jun 05 (Print Publication: 2024).
Publication Type: Journal Article; Clinical Trial, Phase I; Randomized Controlled Trial
Journal Info: Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet ISSN: 1932-6203 (Electronic) Linking ISSN: 19326203 NLM ISO Abbreviation: PLoS One Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Phase 1 randomized trials to assess safety, pharmacokinetics, and vaginal bleeding associated with use of extended duration dapivirine and levonorgestrel vaginal rings.
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  Data: <searchLink fieldCode="AU" term="%22Achilles+SL%22">Achilles SL</searchLink>; Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America.; Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America.<br /><searchLink fieldCode="AU" term="%22Kelly+CW%22">Kelly CW</searchLink>; Statistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Center, Seattle, Washington, United States of America.<br /><searchLink fieldCode="AU" term="%22Hoesley+CJ%22">Hoesley CJ</searchLink>; University of Alabama at Birmingham Heersink School of Medicine, Birmingham, Alabama, United States of America.<br /><searchLink fieldCode="AU" term="%22Blithe+DL%22">Blithe DL</searchLink>; National Institute of Child Health and Human Development, Contraceptive Development Program, DIPHR, NIH, Bethesda, Maryland, United States of America.<br /><searchLink fieldCode="AU" term="%22Brown+J%22">Brown J</searchLink>; National Institute of Child Health and Human Development, Contraceptive Development Program, DIPHR, NIH, Bethesda, Maryland, United States of America.<br /><searchLink fieldCode="AU" term="%22Richardson+BA%22">Richardson BA</searchLink>; Statistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Center, Seattle, Washington, United States of America.; Department of Biostatistics, University of Washington, Seattle, Washington, United States of America.<br /><searchLink fieldCode="AU" term="%22Devlin+B%22">Devlin B</searchLink>; International Partnership for Microbicides, Silver Spring, Maryland, United States of America.<br /><searchLink fieldCode="AU" term="%22Hendrix+CW%22">Hendrix CW</searchLink>; Department of Medicine, Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.<br /><searchLink fieldCode="AU" term="%22Poloyac+SM%22">Poloyac SM</searchLink>; Department of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America.<br /><searchLink fieldCode="AU" term="%22Marzinke+MA%22">Marzinke MA</searchLink>; Department of Medicine, Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.<br /><searchLink fieldCode="AU" term="%22Gundacker+H%22">Gundacker H</searchLink>; Statistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Center, Seattle, Washington, United States of America.<br /><searchLink fieldCode="AU" term="%22Singh+D%22">Singh D</searchLink>; Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America.<br /><searchLink fieldCode="AU" term="%22Piper+JM%22">Piper JM</searchLink>; National Institutes of Allergy and Infectious Disease, NIH, Bethesda, Maryland.<br /><searchLink fieldCode="AU" term="%22Johnson+S%22">Johnson S</searchLink>; FHI 360, Durham, North Carolina, United States of America.<br /><searchLink fieldCode="AU" term="%22Steytler+J%22">Steytler J</searchLink>; International Partnership for Microbicides, Silver Spring, Maryland, United States of America.<br /><searchLink fieldCode="AU" term="%22Chen+BA%22">Chen BA</searchLink>; Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America.; Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America.
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  Data: <searchLink fieldCode="JN" term="%22101285081%22">PloS one</searchLink> [PLoS One] 2024 Jun 05; Vol. 19 (6), pp. e0304552. <i>Date of Electronic Publication: </i>2024 Jun 05 (<i>Print Publication: </i>2024).
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  Data: Journal Article; Clinical Trial, Phase I; Randomized Controlled Trial
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