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


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).



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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Fenton KA. The XI International AIDS Conference in Vancouver. Perspectives from epidemiology and public health.

Genitourinary Med 1996; 72: 370–373.

Saracco A. The urgent need for a vaginal microbicide in the prevention of HIV transmission. Amer J Pub Heal 1994; 84: 890–891.

D’Cruz OJ and Uckun FM. Short term (13 weeks) toxicity study of 5-bromo-6methoxy-5,6 dihydro-3 azidothymidine-5 (pbromophenyl methoxy alaninyl phosphate (WH1-07), a novel anti-HIV and contraceptive agent, in B6C3 F1 mice. Toxicol Sci 2001; 60: 373–378.

Deschamps MM, Pape J and Haner A.

Heterosexual transmission in Haiti. Annals of Int Med 1996; 125: 324–330.

Hardy E, De Padua KS, Jimenez AL and Zaneveld LJD. Women’s preferences for vaginal microbial contraceptives. II. Contraception 1998; 58: 239–244.

Gould D. Contraception: the changing needs of women throughout the reproductive years. Nurs Stand 2000; 14: 37-43.

Elias CJ and Heise LL. Challenges for the development of female controlled vaginal microbicides. AIDS 1994; 8: 1–9.

Anderson RA, Feathergill KA, Hui Diao X,

Cooper MD, Kirkpatrick R, Herold BC,

Doncel GF, Chany CJ, Waller DP, Rencher WF and Zeneveld LJD. Preclinical evaluation of sodium cellulose sulfate (Ushercell) as a contraceptive antimicrobial agent. J Androl 2002; 23: 426–438.

Uckun FM and D’Cruz OJ. Prophylactic contraceptives for HIV/AIDS. Human Reprod Update 1999; 5: 506-14.

Zaneveld LJD, Waller DP, Anderson RA, Chany II, Rencher WF, Feathergil K, Xui Diao X, Doncel GF, Herold B and Cooper M. Efficacy and safety of a new vaginal contraceptive antimicrobial formulation containing high molecular weight polysodium 4-styrenesulfonate. Biol Repro 2002; 66: 886–894.

Zaneveld LJD. Vaginal contraception since 1994: chemical agents and barrier devices. In: Contraceptive Research and Devel. Eds PFA Van Look & G Perez-Palacios. Oxford: Oxford University Press, 1994, 69-90.

D’Cruz OJ, Uckun FM. Clinical development of microbicides for the prevention of HIV infection. Curr Pharm Design 2004;10:31536.

D’Cruz OJ, Uckun FM. Discovery of 2,5dimethoxy-substituted 5-bromopyridyl thiourea ( PHI-236) as a potent broadspectrum anti-human immunodeficiency virus microbicide. Mol Hum Rep 2005; 11:767-777.

D’Hooghe TM, Pudney J and Hill JA. Immunology of the reproductive tract in a female baboon. Am J Primatol 2001; 53:4754.

Jael AO, Maureen NM, Benson MN, Kenneth KW, Isaac M, Idle OF and Peter GM. UniPron is a Fully Effective Nonhormonal Reversible Contraceptive in Baboon Model (Papio anubis). J Repro & Contra 2008; 19(2): 107-118.

Zeitlin L, Hoen T, Achilles S, et al. Tests of BufferGel for contraception and prevention of sexually transmitted diseases in animal models. Sex Trans Dis 2001; 28:417-423.

Brown H. Marvellous microbicides.

Intravaginal gels could save millions of lives, but first someone has to prove that they work. Lancet 2004; 363: 1042-1043.

Blanc AK and Wolff B. Gender and decision-making over condom use in two districts in Uganda. Afr. J Reprod Healt 2001; 5: 5-28.

Woodsong C. Covert use of topical microbicides: Implications for acceptability and use. International Family Planning Perspectives 2004; 30:94-98.

Bentley ME, Fullem AM, Tolley EE, et al. Acceptability of a microbicide among women and their partners in a 4-country phase1 trial. Am J of Publ Healt 2004; 94:1159-1164.

Schill WB and Wolf HH. Ultra structure of human spermatozoa in the presence of the spermicide nonoxynol-9 and a vaginal contraceptive containing nonoxynol-9. Androl 2001; 13: 42-49.

Wilborn WH, Hahn DW and McGuire JJ. Scanning electron microscopy of human spermatozoa after incubation with the spermicide nonoxynol-9. Fertil Steril 1983; 39: 717-719.

Niruthisard SR, Roddy E and Chutivongse S. The effects of frequent nonoxynol –9 use on the vaginal and cervical mucosa. Sex Trans Dis 1991; 18:176-179.

Rekar ML. The toxicity and local effects of the spermicide nonoxynol-9 and genital irritation. J Acquir Imm Defic Synd 1992; 5: 425-427.

Roddy RE, Cordero M, Cordero C and Fortney JA. A dosing of nonoxynol-9 and genital irritation. Int J STD&HIV 1993; 4: 165-170.

Weir SS, Roddy RE, Zeking L and Feldblum PJ. Nonoxynol-9 use, genital ulcers, and HIV infection in a cohort of sex workers. Genitoutin Med 1995; 71: 78-81.

Garg S, Anderson R, Chany C, et al. Properties of a new acid-buffering bioadhesive vaginal formulation (ACIDFORM). Contraception 2001; 64: 67-

Amaral E, Perdigao A, Souza MH, Mauck C, Waller DZL, Faundes A. Vaginal safety after use of a bioadhesive, acid-buffering, microbicidal contraceptive gel (ACIDFORM) and a 2% nonoxynol-9 product. Contraception 2006; 73:542-547.

Hainsey BM, Hubbard GB, Leland MM and Brasky KM. Clinical Parameters of the Normal Baboons (Papio species) and Chimpanzees (Pan troglodytes). Lab Ani Sci 1993; 43: 36-243.


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