Safety Studies of a Recently Developed Microbicidal Contraceptive Gel (UniPron) in Female Baboons (Papio anubis)

Mburu N, Obiero JA, Waititu K, Mwaura BN, Orawo JO, Farah IO, Mwethera PG

Abstract

To identify any toxicity on the vaginal epithelium, liver and kidney following UniPron administration, ten healthy female olive baboons (Papio anubis) of reproductive age and of proven fertility were used. Five baboons were each treated with 15g of UniPron intravaginally twice a week for 20-weeks and venous blood collected before and after each treatment. Venous blood was collected from five control animals as in the experimental females, but these control animals were not given any treatment. The endpoints that were evaluated included clinical chemistry profiles on kidney and liver functions and vaginal histopathology. Female baboons treated with 15g of UniPron intravaginally showed no detectable adverse effects on clinical chemistry profiles investigated and vaginal histopathology. Repeated intravaginal exposure of female baboons to UniPron did not induce detectable vaginal irritation and there were no detectable histological changes. We conclude that administration of UniPron into baboon vagina did not cause any detectable toxicity (Afr J Reprod Health 2009; 13[4]:95-104).

 

RĖSUMĖ

Etudes pour déterminer la sécurité d’un gel contraceptif microbicide (UniPron) chez les babouins (Papio Anubis) qui viennent d’être mis au point. Pour identifier la présence de la toxicité sur l’épithélium vaginal, la foie et le rein suite d’une administration d’UniPron, nous avons utilisé dix babouins (Papio Anubis) olivâtres en bonne santé qui étaient en âge de procréer et d’une fécondité confirmée. Cinq babouins ont été soignés chacune au 15g d’UniPron par voie intravaginale deux fois par semaine pendant 20 semaines et le sang veineux a été collecté avant et après chaque traitement.  Le sang veineux a été collecté de cinq animaux témoin comme dans le cas des femelles d’expérience, mais ces animaux témoin n’ont pas été traités.  Les résultats qui ont été analysés ont compris les profils chimiques clinques sur les fonctions de la foie et du rein et l’histopathologie vaginale.  Les babouins femelles qui ont été soignées au 15g d’UniPron par voie intravaginale n’ont pas eu d’effets négatifs détectables sur les profils chimiques étudiés et sur l’histopathologie.  L’exposition intravaginale répétée des babouins femelles a UniPron n’a pas déclenché l’irritation vaginale détectable et il n’y avait pas de modifications histologiques détectables.  Nous avons conclu que l’administration d’UniPron dans le vagin du babouin n’a causé aucune toxicité détestable (Afr J Reprod Health 2009; 13[4]:95-104).

 

 

KEYWORDS: HIV/AIDS, UniPron, Microbicide, Safety, Toxicity 

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