Phase I safety trial of two vaginal microbicide gels (Acidform or BufferGel) used with a diaphragm compared to KY Jelly used with a diaphragm

Sexually Transmitted Diseases

Volumn 34, Issue 12, 2007, Pages 977-984

  Williams, D'Nyce L ^a,g   Newman, Daniel R ^b   Ballagh, Susan A ^c   Creinin, Mitchell D ^d   Barnhart, Kurt ^e   Weiner, Debra H ^f   Bell, April J ^b   Jamieson, Denise J ^b  

^a EASTERN VIRGINIA MEDICAL SCHOOL   (United States)

^b NATIONAL CENTER FOR CHRONIC DISEASE PREVENTION AND HEALTH PROMOTION   (United States)

^c EASTERN VIRGINIA MEDICAL SCHOOL   (United States)

^d UNIVERSITY OF PITTSBURGH   (United States)

^e HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA   (United States)

^f FAMILY HEALTH INTERNATIONAL   (United States)

^g Mailstop K34 ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACIDFORM; CARBOPOL 974P; KY JELLY; LUBRICATING AGENT; MICROBICIDE; UNCLASSIFIED DRUG;

ABDOMINAL CRAMP; ABSTINENCE; ADULT; ARTICLE; BACKACHE; CLINICAL TRIAL; COLPOSCOPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; ERYTHEMA; EXTERNAL GENITAL ABRASION; EXTERNAL GENITAL ERYTHEMA; FEMALE; FEMALE GENITAL PRURITUS; GYNECOLOGIC DISEASE; HUMAN; INFECTION RISK; LABIA MINORA ABRASION; MYCOSIS; NORMAL HUMAN; PATIENT COMPLIANCE; PHASE 1 CLINICAL TRIAL; PHYSICAL EXAMINATION; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SPOTTING; SUPRAPUBIC DISCOMFORT; TREATMENT OUTCOME; URINARY TRACT INFECTION; UTERINE CERVIX CAP; UTERINE CERVIX DISEASE; VAGINA DISCHARGE; VAGINA ERYTHEMA; VAGINA IRRITATION; VAGINA ODOR; VAGINA SORENESS; VAGINAL PRURITUS; VULVA ERYTHEMA;

ACRYLIC RESINS; ADMINISTRATION, INTRAVAGINAL; ADOLESCENT; ADULT; ANTI-INFECTIVE AGENTS, LOCAL; CELLULOSE; COLPOSCOPY; CONTRACEPTIVE DEVICES, FEMALE; FEMALE; GLYCEROL; HUMANS; MIDDLE AGED; PATIENT ACCEPTANCE OF HEALTH CARE; PHOSPHATES; PROPYLENE GLYCOLS; TREATMENT OUTCOME; VAGINA; VAGINAL CREAMS, FOAMS, AND JELLIES; VAGINOSIS, BACTERIAL;

EID: 36349021921     PISSN: 01485717     EISSN: None     Source Type: Journal    
DOI: 10.1097/OLQ.0b013e31813347e9     Document Type: Article

References (42)

1. Minnis AM, Padian NS. Effectiveness of female controlled barrier methods in preventing sexually transmitted infections and HIV: Current evidence and future research directions. Sex Transm Infect 2005; 81:193-200.
2. Moench TR, Chipato T, Padian NS. Preventing disease by protecting the cervix: The unexplored promise of internal vaginal barrier devices. AIDS 2001; 15:1595-1602.
3. Warner L, Stone KM, Macaluso MM, et al. Condom use and risk of gonorrhea and chlamydia: A systematic review of design and measurement factors assessed in epidemiologic studies. Sex Transm Dis 2006; 33:36-51.
4. Holmes KK, Levine R, Weaver M. Effectiveness of condoms in preventing sexually transmitted infections. Bull World Health Organ 2004; 82:454-461.
5. Weller S, Davis K. Condom effectiveness in reducing heterosexual HIV transmission. Cochrane Database Syst Rev 2001; 3:CD003255.
6. Rosenberg MJ, Davidson AJ, Chen JH, et al. Barrier contraceptives and sexually transmitted diseases in women: A comparison of female-dependent methods and condoms. Am J Public Health 1992; 82:669-674.
7. Amaral E, Perdigao A, Souza M, et al. Postcoital testing after the use of a bio-adhesive acid buffering gel (Acidform) and a 2% Nonoxynol-9 product. Contraception 2004; 70:492-497.
8. Mauck C, Weiner DH, Ballagh S, et al. Single and multiple exposure tolerance study of cellulose sulfate gel: A phase I safety and colposcopy study. Contraception 2001; 64:383-391.
9. Mauck CK, Weiner DH, Ballagh SA, et al. Single and multiple exposure tolerance study of polystyrene sulfonate gel: A phase I safety and colposcopy study. Contraception 2004; 70:77-83.
10. Mayer K, Abdool Karim S, Kelly C, et al. Safety and tolerability of vaginal Pro 2000 gel in sexually active HIV-uninfected and abstinent HIV-infected women. AIDS 2003; 17:321-329.
11. Van Damme L, Chandeying V, Ramjee G, et al. Safety of multiple daily applications of COL-1492, a nonoxynal-9 vaginal gel among female sex workers. AIDS 2000; 14:85-88.
12. Van Damme L, Niruthisard S, Atissok R, et al. Safety evaluation of nonoxynol-9 Gel in women at low risk of HIV infection. AIDS 1998; 12:433-437.
13. Van Damme L, Ramjee G, Vuvlsieke B, et al. Effectiveness of COL-1492, a nonoyxnol-9 vaginal gel, on HIV-1 transmission in female sex workers: A randomized trial. Lancet 2002; 360:971-977.
14. Stafford M, 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.
15. Mayer KH, Peipert J, Fleming T, et al. Safety and tolerability of BufferGel, a novel vaginal microbicide, in women in the United States. Clin Infect Dis 2001; 32:476-482.
16. Spencer S, Valentin-Bon I, Whaley K, et al. Inhibition of neisseria gonorrhoeae genital tract infection by leading candidate topical microbicides in mouse model. J Infect Dis 2004; 189:410-419.
17. Zeitlin L, Hoen TE, Achilles SL, et al. Tests of BufferGel for contraception and prevention of sexually transmitted diseases in animal models. Sex Transm Dis 2001; 28:417-423.
18. Garg S, Anderson R, Chany C, et al. Properties of a new acid-buffering bioadhesive vaginal formulation (Acidform). Contraception 2001; 64:67-75.
19. Van de Wijgert J, Fullem A, Kelly C, et al. Phase 1 trial of the topical microbicide BufferGel: Safety results from four international sites. J Acquir Immun Defic Syndr 2001; 26:21-27.
20. Mahmoud EA, Svensson LO, Olsson SE, et al. Antichlamydial activity of vaginal secretion. Am J Obstet Gynecol 1995; 172:1268-1272.
21. Hanna NF, Taylor-Robinson D, Kalodiki-Karamanoli M, et al. The relation between vaginal pH and the microbiological status in vaginitis. Br J Obstet Gynaecol 1985; 92:1267-1271.
22. Mosher WD, Martinez GM, Chandra A, et al. Use of contraception and use of family planning services in the United States: 1982-2002. Advance Data. Hyattsville, MD: National Center for Health Statistics Division of Vital Statistics, December 10, 2004; 350:1-36.
23. Austin D, Louv WC, Alexander WJ. A case control study of spermicides and gonorrhea. JAMA 1984; 251:2822-2824.
24. Kelaghan J, Rubin GL, Ovy HW, et al. Barrier method contraceptives and pelvic inflammatory disease. JAMA 1982; 248:184-187.
25. Magder LS, Harrison HR, Ehret JM, et al. Factors related to genital chlamydia trachomatis and its diagnosis by culture in a sexually transmitted disease clinic. Am J Epidemiol 1988; 128:298-308.
26. Van der Straten A, Kang M, Posner S, et al. Predictors of diaphragm use as a potential sexually transmitted disease/HIV prevention method in Zimbabwe. Sex Transm Dis 2005; 32:64-71.
27. Amaral E, Faundes A, Zaneveld L, et al. Study of vaginal tolerance to Acidform gel, an acid-buffering, bioadhesive gel. Contraception 1999; 60:361-366.
28. Sullivan A, Edlund C, Nord PC. Effect of antimicrobial agents on the ecological balance of human microflora. Lancet Infect Dis 2001; 1:101-114.
29. Anderson D, Barnhart K, Creinin M, et al. Safety analysis of the diaphragm in combination with vaginal microbicide gels: Effect on cervicovaginal cytokine levels. Microbicides 2006; Abstract PB2.
30. Nugent RP, Krohn MA, Hillier S. Reliability of diagnosing bacterial vaginosis is improved by a standardized method of gram stain interpretation. J Clin Microbiol 1991; 29:297-301.
31. Guidelines for Good Clinical Practice (E6). In the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. FDA, 1996.
32. Roddy RE, Cordero M, Cordero C, et al. A dosing study of N9 and genital irritation. Int J Sex Transm Dis AIDS 1993; 4:165-170.
33. Harwell J, Moench T, Mayer K, et al. A pilot study of treatment of bacterial vaginosis with a buffering vaginal microbicide. J Womens Health (Larchmt) 2003; 12:255-259.
34. Mauck CK, Baker JM, Birnkrant DB, et al. The Use of Colposcopy in Assessing Irritation in Research. AIDS 2000; 14:2221-2227.
35. Behets FM, Braithwaite AR, Hylton-Kong T, et al. Genital ulcers: Etiology, clinical diagnosis, and associated immunodeficiency virus infection in Kingston Jamaica. Clin Inf Dis 1999; 28:1086-1090.
36. Ballagh S. Factors affecting the reproducibility and validity of colposcopy for product development: Review of current literature. J Acquir Immun Defic Syndr 2004; 37(S3):S152-S154.
37. Fraser IS, Lahteenmaki P, Elomaa K, et al. Variations in vaginal epithelial surface appearance determines by colposcopic inspection in healthy, sexually active women. Hum Reprod 1999; 14:1974-1978.
38. World Health Organization and CONRAD. Manual for the Standardization of Colposcopy for the Evaluation of Vaginal Products. Geneva and Arlington: WHO and CONRAD, 2004 (WHO/RHR/04.02 and CONRAD/2004.1).
39. Amaral E, Perdigao A, Souza MH, et al. Vaginal safety after use of a bioadhesive, acid-buffering, microbicide contraceptive gel (Acidform) and a 2% N-9 product. Contraception 2006; 73:542-547.
40. Rosenstein IJ, Stafford MK, Kitchen VS, et al. Effect on normal vaginal flora of three intravaginal microbicide agents potentially active against human immunodeficiency type-1. J Infect Dis 1998; 177:1386-1390.
41. Simoes JA, Bahamondes LG, Camargo RP, et al. A pilot clinical trial comparing an acid-buffering formulation (ACIDFORM) with metronidazole gel for the treatment of symptomatic bacterial vaginosis. Br J Clin Pharmacol 2006; 61:211-217.
42. Behets F, Turner AN, Van Damme K, et al. Acceptability and feasibility of continuous diaphragm use among sex workers in Madagascar. Sex Transm Dis 2005; 81:472-476.