Preliminary safety and acceptability of a carrageenan gel for possible use as a vaginal microbicide

C Coggins¹, K Blanchard¹, F Alvarez², V Brache², E Weisberg³, P H Kilmarx⁴, M Lacarra⁵, R Massai⁶, D Mishell, Jr⁵, A Salvatierra⁶, P Witwatwongwana⁷, C Elias⁸, C Ellertson¹

¹ The Population Council, New York, USA
² Asociacion Dominicana Pro-Bienestar de la Familia, Santo Domingo, Dominican Republic
³ Sydney Centre for Reproductive Health Research, Department of Obstetrics and Gynaecology, University of Sydney, Sydney, Australia
⁴ Centers for Disease Control and Prevention, Atlanta, USA; The HIV/AIDS Collaboration, Chiang Rai, Thailand
⁵ University of Southern California, Los Angeles, USA
⁶ Instituto Chileno de Medicina Reproductiva, Santiago, Chile
⁷ Chiang Rai Hospital, Chiang Rai, Thailand
⁸ The Population Council, Bangkok, Thailand

Correspondence to:
Kelly Blanchard, Population Council, One Dag Hammarskjold Plaza, New York, NY 10017, USA kblanchard{at}pcjoburg.org.za

Objective: We sought to determine the safety and acceptability of vaginal gel formulation PC-503 among low risk, abstinent women. The active ingredient was 2% pharmaceutical grade lambda carrageenan, a sulphated polymer that is generally recognised as safe by the US Food and Drug Administration.

Methods: 35 women in five sites applied 5 ml of the PC-503 gel vaginally once a day for 7 days while abstaining from sexual intercourse. Visual vaginal examinations were performed on days 1, 4, and 8. STI testing and vaginal pool Gram stain preparations were done on days 1 and 8. Participants were asked about product acceptability.

Results: 34 of the 35 women enrolled completed 7 days' use. Following product use, five reported mild symptoms including "bladder fullness," "genital warmth," or discomfort, and lower abdominal pain, and one had moderate pale yellow cervical discharge. Using the Nugent criteria, three women had bacterial vaginosis (BV) before and after use; three had BV before but not after, and two had BV after but not before. Most of the women found PC-503 to be pleasant or neutral in feel and smell and considered extra lubrication to be an advantage; however, one third found it to be messy.

Conclusions: Vaginal use of PC-503 gel did not cause significant adverse effects in a small number of low risk, sexually abstinent women. Further testing in larger numbers of sexually active women is planned. A smaller volume of gel may be more acceptable to some women.

Key Words: microbicide; carrageenan

CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

This article has been cited by other articles:

• Ghosh, T., Chattopadhyay, K., Marschall, M., Karmakar, P., Mandal, P., Ray, B. (2009). Focus on antivirally active sulfated polysaccharides: From structure-activity analysis to clinical evaluation. Glycobiology 19: 2-15 [Abstract] [Full Text]  
• Rando, R. F., Obara, S., Osterling, M. C., Mankowski, M., Miller, S. R., Ferguson, M. L., Krebs, F. C., Wigdahl, B., Labib, M., Kokubo, H. (2006). Critical design features of phenyl carboxylate-containing polymer microbicides.. Antimicrob. Agents Chemother. 50: 3081-3089 [Abstract] [Full Text]  
• Scordi-Bello, I. A., Mosoian, A., He, C., Chen, Y., Cheng, Y., Jarvis, G. A., Keller, M. J., Hogarty, K., Waller, D. P., Profy, A. T., Herold, B. C., Klotman, M. E. (2005). Candidate Sulfonated and Sulfated Topical Microbicides: Comparison of Anti-Human Immunodeficiency Virus Activities and Mechanisms of Action. Antimicrob. Agents Chemother. 49: 3607-3615 [Abstract] [Full Text]  
• Milligan, G. N., Chu, C.-F., Young, C. G., Stanberry, L. R. (2004). Effect of Candidate Vaginally-Applied Microbicide Compounds on Recognition of Antigen by CD4+ and CD8+ T Lymphocytes. Biol. Reprod. 71: 1638-1645 [Abstract] [Full Text]  
• Dezzutti, C. S., James, V. N., Ramos, A., Sullivan, S. T., Siddig, A., Bush, T. J., Grohskopf, L. A., Paxton, L., Subbarao, S., Hart, C. E. (2004). In Vitro Comparison of Topical Microbicides for Prevention of Human Immunodeficiency Virus Type 1 Transmission. Antimicrob. Agents Chemother. 48: 3834-3844 [Abstract] [Full Text]  
• Bentley, M. E., Fullem, A. M., Tolley, E. E., Kelly, C. W., Jogelkar, N., Srirak, N., Mwafulirwa, L., Khumalo-Sakutukwa, G., Celentano, D. D. (2004). Acceptability of a Microbicide Among Women and Their Partners in a 4-Country Phase I Trial. AJPH 94: 1159-1164 [Abstract] [Full Text]  
• Vandebosch, A, Goetghebeur, E, Ramjee, G, Alary, M, Ettiegne-Traore, V, Chandeying, V, Van Damme, L (2004). Acceptability of COL-1492, a vaginal gel, among sex workers in one Asian and three African cities. Sex. Transm. Infect. 80: 241-243 [Abstract] [Full Text]