Unacceptable side-effects associated with a hyperosmolar vaginal microbicide in a phase 1 trial.

@article{Lacey2010UnacceptableSA,
  title={Unacceptable side-effects associated with a hyperosmolar vaginal microbicide in a phase 1 trial.},
  author={Charles John N Lacey and Sarah C Woodhall and Z Qi and Sharada Sawant and Maria Cowen and Sheena McCormack and Shiquang Jiang},
  journal={International journal of STD & AIDS},
  year={2010},
  volume={21 10},
  pages={714-7}
}
We carried out a phase 1 trial of a candidate vaginal microbicide gel against HIV-1 and other sexually transmitted diseases, which contained cellulose acetate 1,2-benzenedicarboxylate (also known as cellulose acetate phthalate) in a glycerol-based vehicle. We had to terminate the study after five women had completed dosing, due to all women experiencing unacceptable vulvo-vaginal side-effects. Further investigations showed that the gel had a very high osmolality, which we believe led to… CONTINUE READING

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