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Abstract
The objectives of this study were 1) to assess the ability of a new contraceptive
vaginal film containing two doses of nonoxynol-9 (N-9) to prevent the penetration
of sperm into midcycle cervical mucus, and 2) to determine the effect of the film
on the vaginal epithelium. The novel formulation was compared with VCF® (a currently marketed film also containing 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-N9 film, a new film containing
either 100 or 130 mg N-9, or VCF containing 70 mg N-9 was used. The sequence of testing
cycles was randomized.
In each cycle, condoms were used prior to midcyle, 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 were as
follows: average of the two baseline cycles, 19.3; test cycle with Allendale-N9 film
containing 100 mg N-9, 0.6; test cycle with Allendale-N9 film containing 130 mg N-9,
0.9; and test cycle with VCF 0.6. There was no significant difference between baseline
cycles or between test cycles in the number of progressively motile sperm per high
power field (HPF) seen (p = 0.31 and p ≥ 0.50, respectively). The average number of
motile sperm seen in each test cycle did, however, differ significantly from the number
in either baseline cycle (p < 0.02). The majority of colposcopic examinations were
normal. In one baseline cycle and eight test cycles, colposcopy showed superficial
de-epithelialization without underlying inflammation. There was no apparent dose response
and in all cases the volunteers were asymptomatic.
A vaginal contraceptive containing either 100 or 130 mg N-9 in a new film base appears
to be safe and comparable to VCF in preventing sperm from entering midcycle cervical
mucus.
Keywords
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References
- The cervix in infertility.Clin Obstet Gynecol. 1979; 22: 27-42
- 3rd edition. Manual for the Standardization of Colposcopy for the Evaluation of Vaginally Administered Products. World Health Organization, Geneva1995
- 3rd edition. WHO Laboratory Manual for the Examination of Human Semen and Sperm-Cervical Mucus Interaction. Cambridge University Press, Cambridge1992
- Frequent use of menfegol spermicidal vaginal foaming tablets associated with a high incidence of genital lesions.J Infect Dis. 1995; 171: 1611-1614
- A dosing study of nonoxynol-9 and genital irritation.Int J STD AIDS. 1993; 4: 165-170
- The effects of frequent nonoxynol-9 use on the vaginal and cervical mucosa.Sex Transm Dis. 1991; 18: 176-179
- The potential of digitally inserted tampons to induce vaginal lesions.Obstet Gynecol. 1985; 66: 31-35
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.
