Mucosal irritation potential of personal lubricants relates to product osmolality as detected by the slug mucosal irritation assay

Sexually Transmitted Diseases

Volumn 35, Issue 5, 2008, Pages 512-516

  Adriaens, Els ^a   Remon, Jean Paul ^a  

^a GHENT UNIVERSITY   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

ASTROGLIDE; FEMGLIDE; K Y JELLY; LUBRICATING AGENT; MICROBICIDE; POLYCARBOPHIL;

ARION LUSITANICUS; ARTICLE; ASSAY; CONTROLLED STUDY; DISEASE SEVERITY; MEMBRANE RESISTANCE; NONHUMAN; ORGANISM; OSMOLALITY; SLUG MUCOSA IRRITATION ASSAY; TISSUE INJURY; VAGINA FLORA; VAGINA MUCOSA; VALIDATION STUDY;

ANIMAL USE ALTERNATIVES; ANIMALS; COITUS; GASTROPODA; LUBRICANTS; MUCOUS MEMBRANE; OSMOLAR CONCENTRATION; VAGINAL CREAMS, FOAMS, AND JELLIES;

EID: 43449092562     PISSN: 01485717     EISSN: None     Source Type: Journal    
DOI: 10.1097/OLQ.0b013e3181644669     Document Type: Article

References (31)

1. Dunn KM, Jordan K, Croft PR, et al. Systematic review of sexual problems: Epidemiology and methodology. J Sex Marital Ther 2002; 28:399-422.
2. Oberg K, Fugl-Meyer AR, Fugl-Meyer KS. On categorization and quantification of women's sexual dysfunctions: An epidemiological approach. Intl J Impot Res 2004; 16:261-269.
3. Jamieson DJ, Steege JF. The prevalence of dysmenorrhea, dyspareunia, pelvic pain, and irritable bowel syndrome in primary care practices. Obstet Gynecol 1996; 87:55-58.
4. DHHS 70A Docket No. 2003 N-0539. Over-the-Counter Drug Products; Safety and Efficacy Review. Available from: http://www.fda.gov/OHRMS/DOCKETS/98fr/03- 32102.pdf.
5. Mate P. Support and self-help for vulvodynia sufferers. In: Glazer NI, Rodke G, eds. The Vulvodynia Survival Guide: New Harbinger Publications; 2002:108.
6. Malonza IM, Mirembe F, Nakabiito C, et al. Expanded Phase I safety and acceptability study of 6% cellulose sulfate vaginal gel. AIDS 2005; 19:2157-2163.
7. Van Damme L, Niruthisard S, Atisook R, et al. Safety evaluation of nonoxynol-9 gel in women at low risk of HIV infection. AIDS 1998; 12:433-437.
8. Van Damme L. Effectiveness of COL-1492, a nonoxynol-9 vaginal gel, on HIV-1 transmission in female sex workers: A randomised controlled trial. Lancet 2002; 360:971-977. Erratum in: Lancet 2002; 360:1892.
9. Stafford MK, Ward H, Flanagan A, et al. Safety study of nonoxynol-9 as a vaginal microbicide: Evidence of adverse effects. J Acquir Immun Defic Syndr 1998; 17:327-331.
10. Ayehunie S, Cannon C, Lamore S, et al. Organotypic human vaginal-ectocervical tissue model for irritation studies of spermicides, microbicides, and feminine-care products. Toxicol in Vitro 2006; 20:689-698.
11. Dhondt MMM, Adriaens E, Remon JP. The evaluation of the local tolerance of vaginal formulations, with or without nonoxynol-9, using the slug mucosal irritation test. Sex Transm Dis 2004; 31:229-235.
12. Dhondt MMM, Adriaens E, Van Roey J, et al. The evaluation of the local tolerance of vaginal formulations containing dapivirine using the Slug Mucosal Irritation test and the rabbit vaginal irritation test. Eur J Pharm Biopharm 2005; 60:419-425.
13. Balzarini J, Naesens L, Verbeken E, et al. Preclinical studies on thiocarboxanilide UC-781 as a virucidal agent. AIDS 1998; 12:1129-1138.
14. Adriaens E, Remon JP. Gastropods as an evaluation tool for screening the irritating potency of absorption enhancers and drugs. Pharm Res 1999; 16:1240-1244.
15. Adriaens E. The Slug Mucosal Irritation assay: An alternative assay for local tolerance testing: National Centre for the Replacement, Refinement and the Reduction of Animals in Research 2006; Available from: http://www.nc3rs.org.uk/ .
16. Schwartz JL, Poindexter A, Schmitz SW, et al. Male tolerance of ACIDFORM gel. Contraception 2005; 71:443-446.
17. Debbasch C, Ebenhahn C, Dami N, et al. Eye irritation of low-irritant cosmetic formulations: Correlation of in vitro results with clinical data and product composition. Food Chem Toxicol 2005; 43:155-165.
18. Agarwal A, Deepinder F, Cocuzza M, et al. Effect of vaginal lubricants on sperm motility and chromatin integrity: A prospective comparative study. Fertil Steril 2007.
19. Fuchs EJ, Lee LA, Torbenson MS, et al. Hyperosmolar sexual lubricant causes epithelial damage in the distal colon: Potential implication for HIV transmission. J Infect Dis 2007; 195:703-710.
20. Owen DH, Katz DF. A vaginal fluid simulant. Contraception 1999; 59:91-95.
21. Owen DH, Katz DF. A review of the physical and chemical properties of human semen and the formulation of a semen simulant. J Androl 2005; 26:459-469.
22. Tien D, Schnaare RL, Kang FR, et al. In vitro and in vivo characterization of a potential universal placebo designed for use in vaginal microbicide clinical trials. AIDS Res Hum Retroviruses 2005; 21:845-853.
23. Schwartz JL, Mauck C, Lai JJ, et al. Fourteen-day safety and acceptability study of 6% cellulose sulfate gel: A randomized double-blind Phase I safety study. Contraception 2006; 74:133-140.
24. Adriaens E, Dhondt MMM, Remon JP. Refinement of the Slug Mucosal Irritation test as an alternative screening test for eye irritation. Toxicol In Vitro 2005; 19:79-89.
25. Meltzer EO, Orgel HA, Bush RK, et al. Evaluation of symptom relief, nasal air-flow, nasal cytology, and acceptability of 2 formulations of flunisolide nasal spray in patients with perennial allergic rhinitis. Ann Allergy 1990; 64:536-540.
26. Wieslander G, Norback D, Lindgren T. Experimental exposure to propylene glycol mist in aviation emergency training: Acute ocular and respiratory effects. Occ Environm Med 2001; 58:649-655.
27. Dhondt MMM, Adriaens E, Remon JP. Evaluation of the local tolerance of vaginal formulations using the slug mucosal irritation test. AAPS Pharm Sci 2003; 4;R6128.
28. Sudol KM, Phillips DM. Relative safety of sexual lubricants for rectal intercourse. Sex Transm Dis 2004; 31:346-349.
29. Dayal MB, Wheeler J, Williams CJ, et al. Disruption of the upper female reproductive tract epithelium by nonoxynol-9. Contraception 2003; 68:273-279.
30. Kutteh WH, Chao CH, Ritter JO, et al. Vaginal lubricants for the infertile couple: Effect on sperm activity. Int J Fertil Menopausal Stud 1996; 41:400-404.
31. Frishman GN, Luciano AA, Maier DB. Evaluation of Astroglide, a new vaginal lubricant - Effects of length of exposure and concentration on sperm motility. Fertil Steril 1992; 58:630-632.