A randomized trial to determine the distribution of four topical gel formulations in the human vagina

Contraception

Volumn 79, Issue 4, 2009, Pages 297-303

  Barnhart, Kurt ^a   Kulp, Jennifer L ^a   Rosen, Mark ^a   Shera, David M ^a  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

Magnetic resonance imaging; Microbicide; Vaginal gel

Indexed keywords

DRUG VEHICLE; GADOLINIUM PENTETATE; HYDROXYPROPYLMETHYLCELLULOSE; METHYLCELLULOSE; MICROBICIDE; SPERMICIDAL AGENT;

ADULT; ARTICLE; BURNING SENSATION; CLINICAL ARTICLE; CLINICAL TRIAL; COMPARATIVE STUDY; CONTRACEPTION; CONTRAST ENHANCEMENT; DRUG DISTRIBUTION; DRUG FORMULATION; FEMALE; GEL; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMAGING SYSTEM; NUCLEAR MAGNETIC RESONANCE IMAGING; PATIENT POSITIONING; PATIENT SAFETY; PRURITUS; SEXUAL INTERCOURSE; SEXUALLY TRANSMITTED DISEASE; THREE DIMENSIONAL IMAGING; VAGINA;

ADMINISTRATION, INTRAVAGINAL; ADOLESCENT; ADULT; ANTI-INFECTIVE AGENTS, LOCAL; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MAGNETIC RESONANCE IMAGING; MIDDLE AGED; VAGINA; VAGINAL CREAMS, FOAMS, AND JELLIES; YOUNG ADULT;

EID: 61549121716     PISSN: 00107824     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.contraception.2008.11.001     Document Type: Article

References (23)

1. UNAIDS/WHO. 2006 Report on the global AIDS epidemic (2006), UNAIDS, Geneva
2. Lederman M.M., Offord R.E., and Hartley O. Microbicides and other topical strategies to prevent vaginal transmission of HIV. Nat Rev Immunol 6 (2006) 371-382
3. Dhawan D., and Mayer K.H. Microbicides to prevent HIV transmission: overcoming obstacles to chemical barrier protection. J Infect Dis 193 (2006) 36-44
4. Van Damme L., Ramjee G., Alary M., et al., COL-1492 Study Group. Effectiveness of COL-1492, a nonoxynol-9 vaginal gel, on HIV-1 transmission in female sex workers: a randomised controlled trial. Lancet 360 (2002) 971-977
5. van de Wijgert J.H., and Shattock R.J. Vaginal microbicides: moving ahead after an unexpected setback. AIDS 21 (2007) 2369-2376
6. Barnhart K.T., Pretorius E.S., Shera D.M., et al. The optimal analysis of MRI data to quantify the distribution of a microbicide. Contraception (2006) 7382-7387
7. Barnhart K.T., Pretorius E.S., Stolpen A., et al. Distribution of topical medication in the human vagina as imaged by MRI. Fertil Steril 76 (2001) 189-195
8. Barnhart K.T., Stolpen A., Pretorius E.S., et al. Distribution of a spermicide containing nonoxynol-9 in the vaginal canal and the upper female reproductive tract. Hum Reprod 16 (2001) 1151-1154
9. Pretorius E.S., Timbers K., Malamud D., et al. Magnetic resonance imaging to determine the distribution of a vaginal gel: before, during and after both real and simulated intercourse. Contraception 66 (2002) 443-451
10. Barnhart K.T., Pretorius E.S., Marunich R., et al. Vaginal distribution of miconazole nitrate suspension from administration of a single vaginal insert. J Reprod Med 49 (2004) 83-88
11. Barnhart K.T., Pretorius E.S., and Malamud D. Lesson learned and dispelled myths: 3 D imaging of the human vagina. Fertil Steril 81 (2004) 1383-1384
12. Barnhart K.T., Pretorius E.S., Timbers K., et al. In vivo distribution of a vaginal gel: MRI evaluation of the effects of gel volume, time, and simulated intercourse. Contraception 70 (2004) 498-505
13. Barnhart K.T., Pretorius E.S., Shaunik A., et al. Vaginal distribution of two volumes of the novel microbicide gel cellulose sulfate (2.5 and 3.5 mL). Contraception 72 (2005) 65-70
14. Barnhart K.T., Pretorius E.S., Timbers K., et al. Distribution of a 3.5-mL (1.0%) C31G vaginal gel using magnetic resonance imaging. Contraception 71 (2005) 357-361
15. Menon S., Izquierdo A., Rosen M., et al. The effect of ambulation on vaginal distribution of miconazole nitrate vaginal Ovule® Insert (1200 mg). J Womens Health 16 (2007) 703-706
16. Siegelman E.S., Outwater E.K., Banner M.P., et al. High resolution MR imaging of the vagina. Radiographics 17 (1997) 1183-1203
17. Barnhart K.T., Izquierdo A., Pretorius E.S., et al. Baseline dimensions of the human vagina. Hum Reprod 21 (2006) 1618-1622
18. Thomsen H.S. Guidelines for contrast media from the European Society of Urogential Radiology. AJR Am J Roentgenol 181 (2003) 1463-1471
19. Owen D.H., Peters J.J., Kieweg S.L., et al. Biophysical analysis of prototype microbicidal gels. J Pharm Sci 96 (2007) 661-669
20. Geonnotti A.R., Peters J.J., and Katz D.F. Erosion of microbicide formulation coating layers: effects of contact and shearing with vaginal fluid and semen. J Pharm Sci 94 (2005) 1705-1712
21. Owen D.H., Peters J.J., and Katz D.F. Rheological properties of contraceptive gels. Contraception 62 (2000) 321-326
22. Owen D.H., Peters J.J., and Katz D.F. Comparison of the rheological properties of Advantage-S and Replens. Contraception 64 (2001) 393-396
23. Owen D.H., Peters J.J., Lavine M.L., et al. Effect of temperature and pH on contraceptive gel viscosity. Contraception 67 (2003) 57-64