Phase I safety trial of two vaginal microbicide gels (Acidform or BufferGel) used with a diaphragm compared to KY jelly used with a diaphragm.
OBJECTIVE
To assess the safety and acceptability of 2 vaginal microbicide gels (Acidform and BufferGel) used with a diaphragm compared to KY Jelly used with a diaphragm among low-risk, sexually abstinent women.


METHODS
Eighty-one women enrolled in a randomized, masked, phase I safety study using a diaphragm with Acidform, BufferGel, or KY Jelly for 6 to 10 hours nightly for 14 nights. Physical examination, colposcopy, and lab studies were performed after 1 and 2 weeks of use. Diaries and questionnaires were used to assess user acceptability.


RESULTS
Sixty-nine participants (85%) completed the study. Safety and acceptability appeared similar among the 3 study groups and no serious adverse events related to the study products were reported. Adverse events were mild and anticipated.


CONCLUSIONS
Acidform and BufferGel compared to KY Jelly, when used with diaphragm daily for 14 days, appeared to be safe and acceptable in a small study of low-risk abstinent women.
Williams
D'Nyce L
DL
CONRAD, Arlington, VA, USA. dlw6@cdc.gov
Newman
Daniel R
DR
Ballagh
Susan A
SA
Creinin
Mitchell D
MD
Barnhart
Kurt
K
Weiner
Debra H
DH
Bell
April J
AJ
Jamieson
Denise J
DJ
D000180:Acrylic Resins / Q000008:administration & dosage / Q000009:adverse effects; D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage / Q000009:adverse effects; D002482:Cellulose / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D003127:Colposcopy; D003274:Contraceptive Devices, Female / Q000706:statistics & numerical data*; D005260:Female; D005990:Glycerol / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D010710:Phosphates / Q000008:administration & dosage / Q000009:adverse effects; D011409:Propylene Glycols / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D014621:Vagina / Q000187:drug effects; D014622:Vaginal Creams, Foams, and Jellies / Q000008:administration & dosage / Q000009:adverse effects; D016585:Vaginosis, Bacterial / Q000517:prevention & control
D000180:Acrylic Resins; D000891:Anti-Infective Agents, Local; C420918:BufferGel; C042973:K-Y jelly; D010710:Phosphates; D011409:Propylene Glycols; D014622:Vaginal Creams, Foams, and Jellies; D002482:Cellulose; D005990:Glycerol