Evaluating the clinical safety of three vaginal applicators: a pilot study conducted in the Dominican Republic.
BACKGROUND
Targeted research on applicator safety has not been conducted as part of microbicide clinical trials and was considered necessary for ensuring safe and effective product use. Colposcopy, regarded as a standard method for assessing the safety of vaginal products, including microbicides, was used in this study to assess the external genitalia, vaginal epithelium and cervical epithelium after a single applicator use.


OBJECTIVE
The objectives of this study were to assess and compare the effects of three vaginal applicators on symptoms and signs of irritation of the external genitalia, vagina and cervix as seen by colposcopy after applicator use.


METHODS
Twenty women used three different vaginal applicators over three separate clinic visits 7-14 days apart and underwent a colposcopic examination before and after each applicator use. In total, the safety of each applicator was assessed over 20 product uses.


RESULTS
No severe colposcopic finding was reported. Four minor colposcopic findings (petechiae) were considered possibly related to product use. No difference was found between applicators.


CONCLUSIONS
This study provides reassuring data on the safety of the three applicator products from the perspective of causing vaginal trauma or irritation. Epithelial changes that could be more important for risk of disease transmission were not observed.
Brache
Vivian
V
Biomedical Research Department, PROFAMILIA, Santo Domingo, Dominican Republic. biomedica@verizon.net.do
Cohen
Jessica A
JA
Cochon
Leila
L
Alvarez
Francisco
F
D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D002584:Cervix Uteri / Q000293:injuries; D003127:Colposcopy; D004293:Dominican Republic; D004867:Equipment Design / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008875:Middle Aged; D014621:Vagina / Q000293:injuries
D000890:Anti-Infective Agents