Phase I safety & preliminary acceptability of nonoxynol-9 vaginal pessary as a vaginal microbicide in low risk women in Pune, India

S. Joshi, N. Joglekar, M. Ghate, J. Unni, A. Risbud, M. Bentley, M. Shepherd, Robert C Bollinger, S. Mehendale

Research output: Contribution to journalArticle

Abstract

Background & objectives: Though nonoxynol-9 (N-9) is available in India as a spermicidal pessary, data on its safety as a potential microbicide among Indian women are not available. Nonoxynol-9 containing compounds have shown anti-HlV activity in in vitro studies and protection against cervical infections. Nonoxynol-9 is being extensively evaluated as a vaginal microbicide world-wide. We assessed the safety and preliminary acceptability of nonoxynol-9 pessary as a vaginal microbicide in women at low risk for human immunodeficiency virus (HIV) infection and sexually transmitted diseases (STDs). Methods: Twenty three HIV seronegative women enrolled in the study were given Today™ pessarys containing 5 per cent of nonoxynol-9 for vaginal use at bedtime for 14 days. Colposcopy was done at enrollment and on day 14 and speculum examination on day 7 to assess the local toxicity. Results: Most of the women (16/23, 69.6%) did not experience any symptoms of genital irritation. The remaining 7 (30.4%, 95% CI 11.6-49.2) women reported 11 episodes of mild irritative symptoms of short duration. On clinical examination, three adverse events were reported of which one could have been product related. Eight (34.8%) women showed willingness to use the product for protection against HIV transmission if it was approved. Interpretation & conclusion: Nonoxynol-9 vaginal pessary was found to be safe and acceptable in once daily dose in low risk women after consecutive use for 14 days. Willingness for future use, if found safe and effective for HIV prevention was shown by 8 (34.8%) women.

Original languageEnglish (US)
Pages (from-to)152-157
Number of pages6
JournalIndian Journal of Medical Research
Volume117
Issue numberAPR.
StatePublished - Apr 1 2003

Fingerprint

Nonoxynol
Pessaries
Anti-Infective Agents
India
Viruses
Safety
HIV
Colposcopy
Toxicity
Virus Diseases
Sexually Transmitted Diseases
Surgical Instruments

Keywords

  • Colposcopy
  • Microbicides
  • Nonoxyno-9
  • Phase I

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)

Cite this

Joshi, S., Joglekar, N., Ghate, M., Unni, J., Risbud, A., Bentley, M., ... Mehendale, S. (2003). Phase I safety & preliminary acceptability of nonoxynol-9 vaginal pessary as a vaginal microbicide in low risk women in Pune, India. Indian Journal of Medical Research, 117(APR.), 152-157.

Phase I safety & preliminary acceptability of nonoxynol-9 vaginal pessary as a vaginal microbicide in low risk women in Pune, India. / Joshi, S.; Joglekar, N.; Ghate, M.; Unni, J.; Risbud, A.; Bentley, M.; Shepherd, M.; Bollinger, Robert C; Mehendale, S.

In: Indian Journal of Medical Research, Vol. 117, No. APR., 01.04.2003, p. 152-157.

Research output: Contribution to journalArticle

Joshi, S, Joglekar, N, Ghate, M, Unni, J, Risbud, A, Bentley, M, Shepherd, M, Bollinger, RC & Mehendale, S 2003, 'Phase I safety & preliminary acceptability of nonoxynol-9 vaginal pessary as a vaginal microbicide in low risk women in Pune, India', Indian Journal of Medical Research, vol. 117, no. APR., pp. 152-157.
Joshi, S. ; Joglekar, N. ; Ghate, M. ; Unni, J. ; Risbud, A. ; Bentley, M. ; Shepherd, M. ; Bollinger, Robert C ; Mehendale, S. / Phase I safety & preliminary acceptability of nonoxynol-9 vaginal pessary as a vaginal microbicide in low risk women in Pune, India. In: Indian Journal of Medical Research. 2003 ; Vol. 117, No. APR. pp. 152-157.
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abstract = "Background & objectives: Though nonoxynol-9 (N-9) is available in India as a spermicidal pessary, data on its safety as a potential microbicide among Indian women are not available. Nonoxynol-9 containing compounds have shown anti-HlV activity in in vitro studies and protection against cervical infections. Nonoxynol-9 is being extensively evaluated as a vaginal microbicide world-wide. We assessed the safety and preliminary acceptability of nonoxynol-9 pessary as a vaginal microbicide in women at low risk for human immunodeficiency virus (HIV) infection and sexually transmitted diseases (STDs). Methods: Twenty three HIV seronegative women enrolled in the study were given Today™ pessarys containing 5 per cent of nonoxynol-9 for vaginal use at bedtime for 14 days. Colposcopy was done at enrollment and on day 14 and speculum examination on day 7 to assess the local toxicity. Results: Most of the women (16/23, 69.6{\%}) did not experience any symptoms of genital irritation. The remaining 7 (30.4{\%}, 95{\%} CI 11.6-49.2) women reported 11 episodes of mild irritative symptoms of short duration. On clinical examination, three adverse events were reported of which one could have been product related. Eight (34.8{\%}) women showed willingness to use the product for protection against HIV transmission if it was approved. Interpretation & conclusion: Nonoxynol-9 vaginal pessary was found to be safe and acceptable in once daily dose in low risk women after consecutive use for 14 days. Willingness for future use, if found safe and effective for HIV prevention was shown by 8 (34.8{\%}) women.",
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AU - Joglekar, N.

AU - Ghate, M.

AU - Unni, J.

AU - Risbud, A.

AU - Bentley, M.

AU - Shepherd, M.

AU - Bollinger, Robert C

AU - Mehendale, S.

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N2 - Background & objectives: Though nonoxynol-9 (N-9) is available in India as a spermicidal pessary, data on its safety as a potential microbicide among Indian women are not available. Nonoxynol-9 containing compounds have shown anti-HlV activity in in vitro studies and protection against cervical infections. Nonoxynol-9 is being extensively evaluated as a vaginal microbicide world-wide. We assessed the safety and preliminary acceptability of nonoxynol-9 pessary as a vaginal microbicide in women at low risk for human immunodeficiency virus (HIV) infection and sexually transmitted diseases (STDs). Methods: Twenty three HIV seronegative women enrolled in the study were given Today™ pessarys containing 5 per cent of nonoxynol-9 for vaginal use at bedtime for 14 days. Colposcopy was done at enrollment and on day 14 and speculum examination on day 7 to assess the local toxicity. Results: Most of the women (16/23, 69.6%) did not experience any symptoms of genital irritation. The remaining 7 (30.4%, 95% CI 11.6-49.2) women reported 11 episodes of mild irritative symptoms of short duration. On clinical examination, three adverse events were reported of which one could have been product related. Eight (34.8%) women showed willingness to use the product for protection against HIV transmission if it was approved. Interpretation & conclusion: Nonoxynol-9 vaginal pessary was found to be safe and acceptable in once daily dose in low risk women after consecutive use for 14 days. Willingness for future use, if found safe and effective for HIV prevention was shown by 8 (34.8%) women.

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