In vivo distribution of a vaginal gel: MRI evaluation of the effects of gel volume, time and simulated intercourse

Barnhart, Kurt T.; Pretorius, E. Scott; Timbers, Kelly; Shera, David; Shabbout, Mayadah; Malamud, Daniel

doi:10.1016/j.contraception.2004.06.013

Cited by 72 publications

(54 citation statements)

References 7 publications

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“…44 These physical changes can alter the surface area of the vagina, affecting the distribution of cervicovaginal secretions and exogenously applied microbicide, that is, HIV preventative products. 45,46 Sexual intercourse can also affect the microbiota of the FRT. Frequent intercourse is associated with greater fluctuation in vaginal flora.…”

Section: Impact Of Sexual Intercourse On Frt Microenvironmentmentioning

confidence: 99%

Role of Semen in Modulating the Female Genital Tract Microenvironment – Implications for HIV Transmission

Doncel

Anderson

Zalenskaya

2014

American J Rep Immunol

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Section: Impact Of Sexual Intercourse On Frt Microenvironmentmentioning

confidence: 99%

Role of Semen in Modulating the Female Genital Tract Microenvironment – Implications for HIV Transmission

Doncel

Anderson

Zalenskaya

2014

American J Rep Immunol

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“…Remote sensing techniques, including MRI, SPECT (single positron emission computed tomography) and gamma scintigraphy, have been applied to study contraceptive, lubricant, moisturizing and prototype microbicidal gels [2][3][4][5][6][7]. These have provided qualitative and quantitative information about the extent to which the gels fill the vaginal space.…”

Section: Introductionmentioning

confidence: 99%

Optical imaging and analysis of human vaginal coating by drug delivery gels

et al. 2007

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Objective-We used a new optical imaging technique to compare human intravaginal coating distributions of Conceptrol® and Advantage™. These gels are surrogates for future microbicidal gels, differing in molecular structures and biophysical properties.Methods-For each protocol, a 3-mL gel bolus was inserted to the posterior fornix while the woman was in the supine position. She then either: (1) remained supine (10 min); or (2) sat up (1 min), stood up (1 min), sat down (1 min), and returned to supine for a net elapsed time of 10 min. The imaging device is sized/shaped like a phallus, and measurements while the device was inserted provide data that simulate peri-intromission coating.Results-Coating by Advantage™ was more extensive and uniform than coating by Conceptrol®, with smaller bare spots of uncoated epithelium. Change in posture tended to increase extent and uniformity of coating, details differing between gels.Conclusions-Results are consistent with predictions of mechanistic coating theory, using gel rheological data as inputs.

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“…However, given a more thorough understanding of vehicle-associated factors (e.g., formulation biophysics) that impact acceptability, these preclinical studies could incorporate acceptability research. For instance, as formulation scientists begin to understand how various biophysical properties of formulations affect deployment (i.e., distribution and retention) characteristics (Barnhart et al, 2004;Fuchs et al, 2005;Geonotti & Katz, 2005;Kieweg, Geonnotti, & Katz, 2004;Kieweg & Katz, 2006), behavioral scientists can collect preliminary data pertaining to the acceptability of various formulations being developed. Choosing what elements are used to develop a stable formulation with a defined set of biophysical properties (pH, viscosity, spreading, shearing, etc.)…”

Section: Preclinical Researchmentioning

confidence: 99%

Assessing Microbicide Acceptability: A Comprehensive and Integrated Approach

Morrow

Ruiz

2007

AIDS Behav

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A safe, effective, and acceptable microbicide is needed in order to decisively impact the global AIDS pandemic. As such, microbicide acceptability research is of paramount importance. In order to best utilize limited financial resources and save precious development time, acceptability studies should be fully integrated into preclinical and clinical trial contexts where candidate products are being developed and tested. An integrated approach for examining theoretically valid and relevant variables is needed so that data across studies and products can more effectively advance the field. We propose an approach for measuring factors related to microbicide acceptability in each phase of product development, and dependent on what product-specific knowledge is already established in the field. We discuss the roles that behavioral and social science methodologies should play in all phases of microbicide development, as well as the challenges faced when conducting acceptability research in the context of preclinical and clinical trial settings. KeywordsMicrobicides; Acceptability; Measurement; Clinical trials; Preclinical development Each day, approximately 14,000 individuals globally are newly infected with HIV; of these, almost half are women (Boonstra, 2000;UNAIDS/WHO, 2005). Even as they face increased risk, many women have little control over HIV/STD prevention decisions. Currently, women must rely on HIV prevention methods that require the knowledge and consent of sex partners (i.e., male condom, female condom, and abstinence) (Bentley et al., 2000;Mason et al., 2003;Wulf, Frost, & Darroch, 1999).Microbicides could change this reality. While the focus has primarily been on developing topical vaginal microbicides, rectal microbicides will likely also have a significant impact on HIV infection rates among both women and men. By developing a product that can be used overtly or covertly (i.e., with or without a partner's knowledge, awareness, or consent), individuals can control their own protection against HIV and, potentially, other STDs. Although not all individuals want or need to use a product covertly, researchers and advocates are particularly interested in the possibility that microbicides could place prevention control in the hands of those who need it. The possibility of covert use would be particularly valuable NIH-PA Author ManuscriptNIH-PA Author Manuscript NIH-PA Author Manuscript in relationships and cultural systems where gender norms or social status limit one's ability to exert control over the timing or frequency of sexual acts. Microbicides containing contraceptive agents may also facilitate fertility regulation.Currently, there are nearly three dozen microbicide candidates in active preclinical and approximately one dozen in clinical development, representing a wide array of potential HIV prevention strategies (Finley, Plescia, Harrison, & des Vignes, 2006). Various biologic strategies to block HIV infection in the context of sexual exposure and several different delivery systems to dep...

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In vivo distribution of a vaginal gel: MRI evaluation of the effects of gel volume, time and simulated intercourse

Cited by 72 publications

References 7 publications

Role of Semen in Modulating the Female Genital Tract Microenvironment – Implications for HIV Transmission

Role of Semen in Modulating the Female Genital Tract Microenvironment – Implications for HIV Transmission

Optical imaging and analysis of human vaginal coating by drug delivery gels

Assessing Microbicide Acceptability: A Comprehensive and Integrated Approach

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