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Original research article| Volume 78, ISSUE 2, P162-166, August 2008

Baseline colposcopic findings in women entering studies on female vaginal products

  • Author Footnotes
    1 Dr. O'Neill is currently affiliated with the Department of Obstetrics and Gynecology, University of North Carolina.
    Erica O'Neill
    Footnotes
    1 Dr. O'Neill is currently affiliated with the Department of Obstetrics and Gynecology, University of North Carolina.
    Affiliations
    Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, Pittsburgh, PA, 15213, USA
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  • Matthew F. Reeves
    Affiliations
    Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, Pittsburgh, PA, 15213, USA

    Magee-Women's Research Institute, Pittsburgh, PA, 15213, USA
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  • Mitchell D. Creinin
    Correspondence
    Corresponding author. Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, Magee-Women's Hospital, Pittsburgh, PA 15213-3180, USA. Tel.: +1 412 641 1441; fax: +1 412 641 1133.
    Affiliations
    Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, Pittsburgh, PA, 15213, USA

    Magee-Women's Research Institute, Pittsburgh, PA, 15213, USA

    Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, 15213, USA
    Search for articles by this author
  • Author Footnotes
    1 Dr. O'Neill is currently affiliated with the Department of Obstetrics and Gynecology, University of North Carolina.

      Abstract

      Background

      Colposcopy is commonly used for genital tract assessment in safety studies on female-controlled vaginal products. However, findings that are considered ���lesions��� are present even without product use. We sought to categorize the type and frequency of lesions found on baseline colposcopy evaluation in healthy women to describe natural lower genital tract changes due to environmental factors.

      Study Design

      We reviewed demographic information and baseline colposcopic examination findings from subjects in 13 studies of vaginal products. All studies included an aim of identifying colposcopic changes as a means of monitoring safety of a vaginal product or device. Colposcopic evaluations were performed according to the WHO/CONRAD Manual for the Standardization of Colposcopy for the Evaluation of Vaginal Products.

      Results

      A total of 317 lesions were found on 569 baseline colposcopy evaluations, with 192 women (34%) having at least one lesion. The most commonly identified lesions were petechiae and erythema, accounting for 45% and 37% of lesions, respectively. Seventy-three percent of lesions were located on the cervix, whereas 15% of lesions were located on the vaginal wall or fornix.

      Conclusions

      Lower genital tract colposcopic findings are common in healthy women. Such findings likely represent normal physiologic changes. Future research needs to address whether routine colposcopic examination is necessary in the evaluation of new vaginal products.

      Keywords

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