Abstract
Background: UniPron is an antimicrobial and a spermicidal agent that contains citric acid as the active component. This study was designed to evaluate the effects of three different concentrations of UniPron in the baboon (Papio anubis) model. Methods: Twenty sexually mature female baboons were used in this study. Vaginal pH and microflora, blood chemistry, vaginal and cervical histology were evaluated at baseline and after administration of 15 ml of UniPron 0.4, 0.8 and 1.2 gm or placebo twice a week for eight weeks to each randomized treatment group. Results: Baseline vaginal pH was 5.2±0.8. There was no significant difference in the vaginal pH and blood chemistry parameters. The microflora composition was diverse and slight variation in percentage frequency between UniPron concentrations was observed. No detectable histological changes were observed in the vaginal or cervical sections. Conclusion: Repeated application of 15 ml of three UniPron concentrations appeared to be safe when administered intravaginally in the baboon model.
Highlights
The role that the vaginal bacteria plays in protecting the host from sexually transmitted infections (STIs), including HIV infection is becoming increasingly appreciated
No significant difference was observed in vaginal pH one week post application
Since consistent and correct use of these products will be critical to their effectiveness, the active pharmaceutical ingredients must be delivered in acceptable vaginal dosage forms such as gels
Summary
The role that the vaginal bacteria plays in protecting the host from sexually transmitted infections (STIs), including HIV infection is becoming increasingly appreciated. Research and development of microbicidal contraceptives has been widely considered as they would ideally provide a convenient, readily available method of self-protection against STIs in addition to preventing unplanned pregnancy [3,4,5]. This female-controlled method of protection would empower women because it offers a system that does not require consent from men. Conclusion: Repeated application of 15 ml of three UniPron concentrations appeared to be safe when administered intravaginally in the baboon model
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