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PROJECT
Clinical Studies: Vaginal Applicators
Prior to the Carraguard® trials, the Population Council conducted a pilot study in South Africa to assess the applicator that would be used in the trials.
Carraguard gel is distributed in pre-filled, single-dose, disposable, plastic Microlax® applicators (made by Norden Pac International AB, Kalmar, Sweden). The applicator has a small bulb that users press between the thumb and forefinger to squeeze the contents out through the elongated nozzle. Each applicator delivers approximately 4 ml of gel into the vagina. Results showed that the Microlax applicator performed well as a delivery system. In the same study methyl cellulose gel was shown to be a safe placebo.
Location
South Africa
Publications/Resources
Council researchers' names appear in boldface type.
2006
Govender,
Sumentheran N.,
Stephanie Skoler,
Robin A. Maguire,
Laura Guichard,
Pekka Lähteenmäki,
Hlengiwe Vilakazi, Fridda Mapula, and Jasmine Rossier. "Evaluation of microbicide
applicators to determine vaginal use in the Carraguard®
Phase 3 clinical trial," presentation at Microbicides
2006, Cape Town, South Africa,
23–26 April. (abstract)
Wallace, Andrea, Aaron Teitelbaum, Livia Wan, Laura Guichard, Robin A. Maguire, and David M. Phillips. "Determining the feasibility of utilizing the microbicide applicator usage assay in clinical trials," presentation at Microbicides 2006, Cape Town, South Africa, 23–26 April. (abstract)
2004
Wallace, Andrea, Mitchell Thorn, Robin A. Maguire,
Kristin M. Sudol, and David M. Phillips. 2004. "Assay for
establishing whether microbicide applicators have been exposed to the
vagina," Sexually Transmitted Diseases 31(8): 465–468. (abstract)
See Also
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Protocol 342 (applicator usage)
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This page updated |
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What's New |
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Council selects Louise Pedneault clinical director, microbicides, HIV and AIDS program (more) Presentations by Council researchers at the Microbicides 2008 conference in New Delhi are now available. (more) "Disappointment in trials another lesson," 26 February 2008 op-ed from The Star, South Africa (posted with permission) (PDF) The results of the Phase 3 Carraguard® trial have been announced. (more) For fact sheets and other resources about the Carraguard trial, click here. "Benefits of the Population Council's microbicides program and Phase 3 Carraguard trial" (2008) (PDFs: A4 and letter) "Day of dialogue—Insights and evidence from product introduction: Lessons for microbicides" (2007) (PDF) "Ethics in clinical trials: Population Council's microbicides program," describes the Council's efforts to ensure microbicide research is ethical and transparent. (PDF) Stay Informed |
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Publications/Resources |
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"Preferences and practices related to vaginal lubrication: Implications for microbicide acceptability and clinical testing" (2005) (abstract) The Council has a fact sheet for those seeking additional information about the Carraguard trials: "The Population Council, HIV and AIDS, and microbicides" (full text) (PDF) "Developing and testing a gel to prevent HIV transmission" (2005) (full text) |