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Abstract
Benzalkonium chloride (BZK) has been shown in in vitro and in vivo studies to immobilize
sperm, to be active against STD-causing organisms, and to penetrate and thicken cervical
mucus. A US clinical study of a sponge containing 60 mg BZK showed life table pregnancy
rates at 6 and 12 months of 11.7 and 18.9 per 100 women, respectively. BZK is not
currently marketed in the US as a contraceptive.
The present study aimed to assess 1) the ability of a new contraceptive vaginal film
containing either of two doses of BZK to prevent the penetration of sperm into midcycle
cervical mucus; 2) the effect of the film on the vaginal epithelium; and 3) the acceptability
of the film. All results were compared with VCF®, a currently marketed film containing nonoxynol-9 (N-9).
Ten women underwent two baseline cycles of postcoital testing in which no film was
used, followed by three test cycles in which Allendale-BZK film, a new film containing
either 19 or 25 mg BZK, or VCF, containing 70 mg N-9, was used. The sequence of testing
cycles was randomized.
In each cycle, condoms were used prior to midcycle, then a midcycle cervical mucus
specimen was examined to ensure midcycle characteristics and the absence of sperm.
Each woman then had intercourse using either no film (baseline cycles) or a test film
(test cycles) and returned 2–3 h afterwards. Cervical mucus was again assessed for
adequacy and the presence of sperm. Each woman also underwent colposcopy, using a
protocol developed by the World Health Organization.
The average number of progressively motile sperm seen per high power field was as
follows: first baseline cycle, 22.2; second baseline cycle, 22.1; test cycle with
film containing 19 mg BZK, 0.2; test cycle with film containing 25 mg BZK, 0.0; and
test cycle with VCF containing 70 mg N-9, 0.0. There was no significant difference
between baseline cycles or among test cycles in the average number of progressively
motile sperm seen (p = 0.78 and p ≥ 0.75, respectively). The average number of progressively
motile sperm seen in each test cycle did, however, differ significantly from the average
number seen in either baseline cycle (p < 0.01). Colposcopy showed superficial de-epithelialization
without underlying inflammation in 15–20% of baseline cycles, regardless of whether
colposcopy was done before or after coitus; in 50% of cycles in which either dose
of BZK was used; and in 69% of cycles in which VCF was used. In all cases women were
asymptomatic. Erythema and petechiae were also seen on colposcopy although at a lower
frequency than de-epithelialization. There was no difference in the acceptability
of the films.
A vaginal contraceptive containing either 19 or 25 mg BZK in a new film base appears
to be comparable with VCF in preventing sperm from entering midcycle cervical mucus
and may be somewhat less disruptive to the vaginal epithelium.
Keywords
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Article info
Publication history
Accepted:
June 2,
1997
Received in revised form:
May 23,
1997
Received:
April 22,
1997
Identification
Copyright
© 1997 Published by Elsevier Inc.
