Expanded Phase I safety and acceptability study of 6% cellulose sulfate vaginal gel.

@article{Malonza2005ExpandedPI,
  title={Expanded Phase I safety and acceptability study of 6% cellulose sulfate vaginal gel.},
  author={Isaac M Malonza and Florence Maureen Mirembe and Clemensia Nakabiito and Lawrence O Odusoga and Olubunmi Adetokunbo Osinupebi and Kamal T Hazari and Shanta M. Chitlange and Mohamed Mahmoud Ali and Marianne Callahan and Lut van Damme},
  journal={AIDS},
  year={2005},
  volume={19 18},
  pages={2157-63}
}
BACKGROUND An expanded Phase I trial was performed to assess the safety and acceptability of 6% cellulose sulfate gel (CS) in comparison with K-Y Jelly. METHODS Sexually abstinent (cohort I) and sexually active (cohort II) women in India, Nigeria and Uganda applied 3.5 ml of either 6% CS gel or K-Y Jelly for seven consecutive days. Safety was assessed by symptoms and signs (including colposcopy) of genital irritation, review of adverse events, and by changes in vaginal health as assessed by… CONTINUE READING

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