The effects of frequent nonoxynol-9 use on the vaginal and cervical mucosa
Niruthisard, S.; Roddy, R.E.; Chutivongse, S.
Sexually Transmitted Diseases 18(3): 176-179
1991
ISSN/ISBN: 0148-5717 PMID: 1658953 DOI: 10.1097/00007435-199107000-00010Document Number: 316903
A Phase I type clinical trial was conducted to study the local toxic effects of nonoxynol-9 (N-9) on the vaginal and cervical mucosa of women, to see whether a Phase II trial is needed, since women may use the spermicide frequently to prevent sexually transmitted diseases. 14 women inserted suppositories containing 150 mg N-9 every hour for 4 doses for 14 days. They were checked before the trail and for 2 or 3 weeks, with pelvic exam, smears for trichomonas and monilia, and colposcopy. 5 women inserted placebos to blind the trial. 43$ of the subjects had physical findings including sloughing of the cervical epithelium in 4, cervical erythema in 4, cervical bleeding in 1, vaginal erythema in 3, vaginal sloughing and bleeding in 1, vaginal dryness in 3, dryness in 2 and itching in 2. The cervical sloughing did not cross the transformation zone. 1 woman had edema and bleeding of the cervix resembling severe strawberry cervix. All symptoms resolved in 1 week. No effects were seen on the vulva, perineum or anus. The dose and frequency of use of N-9 in this trail are larger than women would normally be expected to use, but the data do justify a Phase II study.