Documenting intermenstrual bleeding in a vaginal microbicide study: Case reports and lessons learned [1]

AIDS Research and Human Retroviruses

Volumn 22, Issue 3, 2006, Pages 294-296

  Joshi, Smita ^a,i   Dutta, Soma ^a   Bell, Beverly ^b   Profy, Albert ^c   Kuruc, JoAnn ^b   Fang, Gai ^d   Cianciola, Missy ^d   Maslankowski, Lisa ^e   Soto Torres, Lydia ^f   Panchanadikar, Anjali ^a   Mehendale, Sanjay ^a   Reynolds, Steven J ^f,g,h  

^a NATIONAL AIDS RESEARCH INSTITUTE   (India)

^b FAMILY HEALTH INTERNATIONAL   (United States)

^c Indevus Pharmaceuticals Inc   (United States)

^d Fred Hutchinson Cancer Research Center   (United States)

^e UNIVERSITY OF PENNSYLVANIA   (United States)

^f NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^g JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^h HIV Prevention Trial Network (HPTN) 047 Protocol Team

ⁱ Maharashtra Industrial Development Corporation India   (India)

Author keywords

[No Author keywords available]

Indexed keywords

MICROBICIDE; ORAL CONTRACEPTIVE AGENT; PRO 2000;

BREAKTHROUGH BLEEDING; CLINICAL ARTICLE; CLINICAL TRIAL; COLPOSCOPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; FOLLOW UP; HUMAN; LETTER; MICROBIAL SENSITIVITY TEST; PARTIAL THROMBOPLASTIN TIME; PHASE 1 CLINICAL TRIAL; PRACTICE GUIDELINE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; UTERUS BLEEDING; VAGINITIS;

ADMINISTRATION, INTRAVAGINAL; ANTI-INFECTIVE AGENTS, LOCAL; COLPOSCOPY; DRUG ADMINISTRATION SCHEDULE; FEMALE; GELS; HUMANS; METRORRHAGIA; NAPHTHALENESULFONATES; POLYMERS; VAGINOSIS, BACTERIAL;

EID: 33645366738     PISSN: 08892229     EISSN: None     Source Type: Journal    
DOI: 10.1089/aid.2006.22.294     Document Type: Letter

References (6)

1. Van Damme L, Wright A, Depraetere K, et al.: A phase I study of a novel potential intravaginal microbicide, PRO 2000, in healthy sexually inactive women. Sex Transm Inf 2000;76:126-130.
2. Mayer KH, Karim SA, 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.
3. Low-Beer N, Gabe R, McCormack S, et al.: Dextrin sulfate as a vaginal microbicide: randomized, double-blind, placebo-controlled trial including healthy female volunteers and their male partners. J Acquir Immune Defic Syndr 2002;31:391-398.
4. Bukenya M, Pickering J, Mukwaya S, et al.: A safety study of dextrin sulphate vaginal microbicide [Abstract 02002]. Microbicides 2004, London, UK, March 28-31, 2004, pp. 28-31.
5. Christianson K, Peterson A, Cosgrove Sweeney Y, et al: PRO 2000 Gel safety studies conducted in the Macaca nemestrina model [Abstract A-183]. Microbicides 2002, Antwerp, Belgium, May 12-15, 2002.
6. Greenhead P, Hayes P, Watts P, et al.: Parameters of human immunodeficiency virus infection of human cervical tissue and inhibition by vaginal virucides. J Virol 2000;74:5577-5586.