Original research article| Volume 56, ISSUE 2, P89-96, August 1997

A phase I comparative study of contraceptive vaginal films containing benzalkonium chloride and nonoxynol-9

Postcoital testing and colposcopy
      This paper is only available as a PDF. To read, Please Download here.


      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.


      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to Contraception
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Chantler E
        • Fisher H
        • Solanki S
        • Elstein M
        Quantification of the in vitro activity of some compounds with spermicidal activity.
        Contraception. 1992; 46: 527-536
        • Erny R
        • Siboni C
        The effect of benzalkonium chloride on ovulatory cervical mucus.
        Acta Eur Fertil. 1987; 18: 109-111
        • Mendez F
        • Castro A
        Prevention of sexual transmission of AIDS/STD by a spermicide containing benzalkonium chloride.
        Arch AIDS Res. 1990; 4: 115-136
        • Wainberg MA
        • Spira B
        • Bleau G
        • Thomas R
        Inactivation of human immunodeficiency virus type I in tissue culture fluid and in genital secretions by the spermicide benzalkonium chloride.
        J Clin Microbiol. 1990; 28 (Jan): 156-158
        • Bernstein G
        Final report, evaluation of a polyvinyl vaginal contraceptive sponge containing benzalkonium chloride.
        Contract No. N01-HD-5-2936. 12/31/1989;
        • Moghissi K
        Postcoital test: physiologic basis, technique, and interpretation.
        Fertil Steril. 1976; 27: 117-129
        • World Health Organization
        3rd edition. WHO Laboratory Manual for the Examination of Human Semen and Sperm-Cervical Mucus Interaction. Cambridge University Press, Cambridge1992
        • Goeman J
        • Ndoye I
        • Sakho LM
        • et al.
        Frequent use of menfegol spermicidal vaginal foaming tablets associated with a high incidence of genital lesions.
        J Infect Dis. 1995; 171: 1611-1614
        • Roddy RE
        • Cordero M
        • Cordero C
        • Fortney J
        A dosing study of nonoxynol-9 and genital irritation.
        Int J STD AIDS. 1993; 4: 165-170
        • Niruthisard S
        • Roddy RE
        • Chutivongse S
        The effects of frequent nonoxynol-9 use on the vaginal and cervical mucosa.
        Sex Transm Dis. 1991; 18: 176-179
        • Berkeley AS
        • Micha JP
        • Freedman KS
        • Hirsch JC
        The potential of digitally inserted tampons to induce vaginal lesions.
        Obstet Gynecol. 1985; 66: 31-35
        • Patton DL
        • Sweeney YC
        • Rabe LK
        • Hillier SL
        The vaginal microflora of pig-tailed macaques and the effects of chlorhexidine and benzalkonium on this ecosystem.
        Sex Transm Dis. 1996; 23: 489-493