Immune Modulation by Misoprostol

Summary

The present study is designed to address the null hypothesis that there is no difference in the local and systemic immunomodulatory effects of buccally or vaginally administered misoprostol in healthy, reproductive-age women.

Timeline

Start

2014-11

Primary completion

2015-07

Completion

2015-11

Publications

• Background Moran M, Mozes MF, Maddux MS, Veremis S, Bartkus C, Ketel B, Pollak R, Wallemark C, Jonasson O. Prevention of acute graft rejection by the prostaglandin E1 analogue misoprostol in renal-transplant recipients treated with cyclosporine and prednisone. N Engl J Med. 1990 Apr 26;322(17):1183-8. doi: 10.1056/NEJM199004263221703.
• Background Pouteil-Noble C, Chapuis F, Berra N, Hadj-Aissa A, Lacavalerie B, Lefrancois N, Martin X, Touraine JL. Misoprostol in renal transplant recipients: a prospective, randomized, controlled study on the prevention of acute rejection episodes and cyclosporin A nephrotoxicity. Nephrol Dial Transplant. 1994;9(5):552-5. doi: 10.1093/ndt/9.5.552.
• Background Zieman M, Fong SK, Benowitz NL, Banskter D, Darney PD. Absorption kinetics of misoprostol with oral or vaginal administration. Obstet Gynecol. 1997 Jul;90(1):88-92. doi: 10.1016/S0029-7844(97)00111-7.
• Background Waiser J, Bohler T, Stoll J, Schumann B, Budde K, Neumayer HH. The immunosuppressive potential of misoprostol--efficacy and variability. Clin Immunol. 2003 Dec;109(3):288-94. doi: 10.1016/j.clim.2003.08.009.
• Background Middleton T, Schaff E, Fielding SL, Scahill M, Shannon C, Westheimer E, Wilkinson T, Winikoff B. Randomized trial of mifepristone and buccal or vaginal misoprostol for abortion through 56 days of last menstrual period. Contraception. 2005 Nov;72(5):328-32. doi: 10.1016/j.contraception.2005.05.017. Epub 2005 Aug 9.
• Background Tang OS, Ho PC. The pharmacokinetics and different regimens of misoprostol in early first-trimester medical abortion. Contraception. 2006 Jul;74(1):26-30. doi: 10.1016/j.contraception.2006.03.005. Epub 2006 Apr 27.
• Background el-Refaey H, Rajasekar D, Abdalla M, Calder L, Templeton A. Induction of abortion with mifepristone (RU 486) and oral or vaginal misoprostol. N Engl J Med. 1995 Apr 13;332(15):983-7. doi: 10.1056/NEJM199504133321502.
• Background Ho PC, Ngai SW, Liu KL, Wong GC, Lee SW. Vaginal misoprostol compared with oral misoprostol in termination of second-trimester pregnancy. Obstet Gynecol. 1997 Nov;90(5):735-8. doi: 10.1016/S0029-7844(97)00419-5.
• Background Silverstein FE, Graham DY, Senior JR, Davies HW, Struthers BJ, Bittman RM, Geis GS. Misoprostol reduces serious gastrointestinal complications in patients with rheumatoid arthritis receiving nonsteroidal anti-inflammatory drugs. A randomized, double-blind, placebo-controlled trial. Ann Intern Med. 1995 Aug 15;123(4):241-9. doi: 10.7326/0003-4819-123-4-199508150-00001.
• Background Herting RL, Clay GA. Overview of clinical safety with misoprostol. Dig Dis Sci. 1985 Nov;30(11 Suppl):185S-193S. doi: 10.1007/BF01309407.
• Background Wildeman RA. Focus on misoprostol: review of worldwide safety data. Clin Invest Med. 1987 May;10(3):243-5.
• Background Rostom A, Dube C, Wells G, Tugwell P, Welch V, Jolicoeur E, McGowan J. Prevention of NSAID-induced gastroduodenal ulcers. Cochrane Database Syst Rev. 2002;(4):CD002296. doi: 10.1002/14651858.CD002296.
• Background Chong E, Tsereteli T, Nguyen NN, Winikoff B. A randomized controlled trial of different buccal misoprostol doses in mifepristone medical abortion. Contraception. 2012 Sep;86(3):251-6. doi: 10.1016/j.contraception.2011.12.012. Epub 2012 Feb 2.
• Background Raymond EG, Shannon C, Weaver MA, Winikoff B. First-trimester medical abortion with mifepristone 200 mg and misoprostol: a systematic review. Contraception. 2013 Jan;87(1):26-37. doi: 10.1016/j.contraception.2012.06.011. Epub 2012 Aug 13.
• Background Kotsonis FN, Dodd DC, Regnier B, Kohn FE. Preclinical toxicology profile of misoprostol. Dig Dis Sci. 1985 Nov;30(11 Suppl):142S-146S. doi: 10.1007/BF01309401.
• Background Zane S, Guarner J. Gynecologic clostridial toxic shock in women of reproductive age. Curr Infect Dis Rep. 2011 Dec;13(6):561-70. doi: 10.1007/s11908-011-0207-7.
• Background Fjerstad M, Trussell J, Sivin I, Lichtenberg ES, Cullins V. Rates of serious infection after changes in regimens for medical abortion. N Engl J Med. 2009 Jul 9;361(2):145-51. doi: 10.1056/NEJMoa0809146.
• Background Hemmerling A. The safety of misoprostol. ELSEVIER IRELAND LTD; 2006.

Drugs

Indications

No indication recorded.