Experience of conducting a phase i safety and acceptability clinical trial of a candidate vaginal microbicide and lessons learned
Dutta, S.; Joglekar, N.; Joshi, S.; Steven, J.R.
Indian Journal of Medical Research 128(2): 212-213
2008
ISSN/ISBN: 0019-5340 PMID: 19001688 Document Number: 619918
Document emailed within 1 workday
Related Documents
Jones, H.E.; Chaikummao, S.; van de Wijgert, J.H.H.M.; Friedland, B.A.; Manopaiboon, C.; Witwatwongwana, P.; Wankrairot, M.; Chantharojwong, N.; Kilmarx, P.H. 2009: Acceptability of a carrageenan-based candidate vaginal microbicide and matching placebo: findings from a phase Ii safety trial among women in Chiang Rai, Thailand Journal of Women's Health 18(7): 1003-1010Altini, L.; Blanchard, K.; Coetzee, N.; de Kock, A.; Elias, C.; Ellertson, C.; Friedland, B.; Hoosen, A.; Jones, H.E.; Kilmarx, P.H.; Marumo, M.; McGrory, E.; Monedi, C.; Ndlovu, G.; Nkompala, B.; Pistorius, A.; Ramjee, G.; Sebola, M.; Sorhaindo, A.; Turner, A.N.; Tweedy, K.; van de Wijgert, J.; Williams, M.M.; Williams, M.M.; Winikoff, B. 2010: Expanded safety and acceptability of the candidate vaginal microbicide Carraguard® in South Africa Contraception 82(6): 563-571
Joshi, S.; Joglekar, N.; Ghate, M.; Unni, J.; Risbud, A.; Bentley, M.; Shepherd, M.; Bollinger, R.; Mehendale, S. 2003: Phase i safety and preliminary acceptability of nonoxynol-9 vaginal pessary as a vaginal microbicide in low risk women in Pune, India Indian Journal of Medical Research 117: 152-157
Catalone, B.J.; Kish-Catalone, T.M.; Neely, E.B.; Budgeon, L.R.; Ferguson, M.L.; Stiller, C.; Miller, S.R.; Malamud, D.; Krebs, F.C.; Howett, M.K.; Wigdahl, B. 2005: Comparative safety evaluation of the candidate vaginal microbicide C31G Antimicrobial Agents and ChemoTherapy 49(4): 1509-1520
Isaacs, C.E.; Pullarkat, R.; Kascsak, R. 2001: Development of a topical vaginal microbicide: lessons learned from human milk Advances in Experimental Medicine and Biology 501: 223-232
Ettiègne-Traoré, V.; Ghys, P.D.; Van Damme, L.; N'Krumah, M.; Maïga, A.; Tiémelé, A.; Mah-bi, G.; Coulibaly, I.M.; Laga, M.; Greenberg, A.E. 1997: Acceptability and feasibility of a clinical trial to assess the efficacy of a microbicide-containing vaginal gel to prevent HIV infection among female sex workers in Abidjan, Côte d'Ivoire Aids 11(13): 1660-1662
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 American Journal of Public Health 94(7): 1159-1164
Jespers, V.; Buvé, A.; Van Damme, L. 2007: Safety trial of the vaginal microbicide cellulose sulfate gel in HIV-positive men Sexually Transmitted Diseases 34(7): 519-522
Msellati, P.; Meda, N.; Leroy, V.; Likikouët, R.; Van de Perre, P.; Cartoux, M.; Bonard, D.; Ouangre, A.; Combe, P.; Gautier-Charpentier, L.; Sylla-Koko, F.; Lassalle, R.; Dosso, M.; Welffens-Ekra, C.; Dabis, F.; Mandelbrot, L. 1999: Safety and acceptability of vaginal disinfection with benzalkonium chloride in HIV infected pregnant women in west Africa: ANRS 049b phase Ii randomized, double blinded placebo controlled trial. DITRAME Study Group Sexually Transmitted Infections 75(6): 420-425
Keller, M.J.; Carpenter, C.A.; Lo, Y.; Einstein, M.H.; Liu, C.; Fredricks, D.N.; Herold, B.C. 2012: Phase i randomized safety study of twice daily dosing of acidform vaginal gel: candidate antimicrobial contraceptive Plos one 7(10): E46901
Braunstein, S.; van de Wijgert, J. 2005: Preferences and practices related to vaginal lubrication: implications for microbicide acceptability and clinical testing Journal of Women's Health 14(5): 424-433
Stuart, G.S.; Lesko, C.R.; Stuebe, A.M.; Bryant, A.G.; Levi, E.E.; Danvers, A.I. 2015: A randomized trial of levonorgestrel intrauterine system insertion 6 to 48 h compared to 6 weeks after vaginal delivery; lessons learned Contraception 91(4): 284-288
Greene, E.; Batona, G.; Hallad, J.; Johnson, S.; Neema, S.; Tolley, E.E. 2010: Acceptability and adherence of a candidate microbicide gel among high-risk women in Africa and India Culture Health and Sexuality 12(7): 739-754
Hemmerling, A.; Potts, M.; Walsh, J.; Young-Holt, B.; Whaley, K.; Stefanski, D.A. 2007: Lime juice as a candidate microbicide? An open-label safety trial of 10% and 20% lime juice used vaginally Journal of Women's Health 16(7): 1041-1051
Weiss, E.; Rao Gupta, G. 1996: Lessons learned from conducting sexuality research ELEVENTH INTERNATIONAL CONFERENCE ON AIDS Author Eleventh International Conference on AIDS, Vol One One world: One hope : 388
Kilmarx, P.H.; Blanchard, K.; Chaikummao, S.; Friedland, B.A.; Srivirojana, N.; Connolly, C.; Witwatwongwana, P.; Supawitkul, S.; Mock, P.A.; Chaowanachan, T.; Tappero, J. 2008: A randomized, placebo-controlled trial to assess the safety and acceptability of use of carraguard vaginal gel by heterosexual couples in Thailand Sexually Transmitted Diseases 35(3): 226-232
Jacobs, B.P.; Mehling, W.; Avins, A.L.; Goldberg, H.A.; Acree, M.; Lasater, J.H.; Cole, R.J.; Riley, D.S.; Maurer, S. 2004: Feasibility of conducting a clinical trial on Hatha yoga for chronic low back pain: methodological lessons Alternative Therapies in Health and Medicine 10(2): 80-83
Whitehead, S.J.; McLean, C.; Chaikummao, S.; Braunstein, S.; Utaivoravit, W.; van de Wijgert, J.H.; Mock, P.A.; Siraprapasiri, T.; Friedland, B.A.; Kilmarx, P.H.; Markowitz, L.E. 2011: Acceptability of Carraguard vaginal microbicide gel among HIV-infected women in Chiang Rai, Thailand Plos one 6(9): E14831
Zaman, K.; Yunus, M.; El Arifeen, S.; Azim, T.; Faruque, A.S.G.; Huq, E.; Hossain, I.; Luby, S.P.; Victor, J.C.; Dallas, M.J.; Lewis, K.D.C.; Rivers, S.B.; Steele, A.D.; Neuzil, K.M.; Ciarlet, M.; Sack, D.A. 2012: Methodology and lessons-learned from the efficacy clinical trial of the pentavalent rotavirus vaccine in Bangladesh Vaccine 30(Suppl 1): A94-100
Chi, I.C.; Smith, S.C.; Borko, E.; Sun, T.H.; Begum, S.F.; Hunt, W.L.; Wilkens, L.R. 1987: Clinical acceptability, use-patterns and use-effectiveness of the vaginal contraceptive sponge and Neo Sampoon tablets--an international multi-center randomized clinical trial Contraception 36(5): 499-514