Abstract
Objective
ACIDFORM is a candidate microbicide with spermicidal properties. A large Phase 3 trial
is underway, and it is anticipated that this product will be approved for contraceptive
use and marketed soon in the United States. The goal of this article is to critically
review the evidence supporting the properties, safety profile and different uses of
ACIDFORM gel.
Study design
We searched PubMed and Medline for any published literature on ACIDFORM.
Results
ACIDFORM is an acidifying agent that works by lowering the vaginal pH to enhance the
normal vaginal defenses. In addition to strong acid-buffering properties, ACIDFORM
has high bioadhesive and viscosity-retaining properties. Several Phase 1 clinical
trials have demonstrated the vaginal safety of ACIDFORM used alone or in combination
with a diaphragm, although dose-dependent side effects appear to be present. Studies
investigating the efficacy of ACIDFORM against sexually transmitted infections (STIs)
are promising, but further trials are needed.
Conclusions
The properties of ACIDFORM offer many advantages for use, either alone or in combination
with another active ingredient, such as Tenofovir. Potential applications for ACIDFORM
include use as a personal lubricant, a vaginal contraceptive (alone or with a barrier
method) and a microbicidal product or as a formulation vehicle for an active ingredient.
Implications
ACIDFORM is a candidate female-controlled vaginal preparation with microbicidal and
spermicidal properties. A dual protection method could prevent unwanted pregnancies
and reduce the risk of STI acquisition.
Keywords
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Article info
Publication history
Published online: January 31, 2014
Accepted:
January 20,
2014
Received in revised form:
January 19,
2014
Received:
October 4,
2013
Footnotes
☆Funding: No funding was provided for this manuscript.
☆☆Conflicts of interest: Lisa L. Bayer has no conflicts of interest to disclose. Jeffrey T. Jensen has received research funds and payments for consulting from Evofem. This potential conflict of interest has been reviewed and managed by Oregon Health & Science University.
Identification
Copyright
© 2014 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
