| Literature DB >> 1658953 |
S Niruthisard1, R E Roddy, S Chutivongse.
Abstract
The authors conducted a single-dose phase I local toxicity study of the effects of frequent insertion of nonoxynol-9 (N-9) on the lower genital tract to determine whether a phase II dose-ranging study is warranted. Fourteen women used 150 mg of N-9 cumulatively four times a day for 14 days. Epithelial disruption of the cervix and vagina, the main outcome of interest, occurred in 43% (95% CI, 18-71%) of women on this high-frequency use schedule. None of the women experienced symptoms that prompted them to discontinue the study. This preliminary study indicates that a phase II study to examine the local toxicity of different use schedules is needed to provide further safety information about the use of N-9.Entities:
Keywords: Asia; Biology; Bleeding; Cervical Effects; Cervix; Contraception; Contraceptive Agents; Contraceptive Methods; Dermatitis; Developing Countries; Diseases; Double-blind Studies; Edema; Family Planning; Genitalia; Genitalia, Female; Nonoxynol-9; Physiology; Pruritus; Research Methodology; Research Report; Signs And Symptoms; Southeastern Asia; Spermicidal Contraceptive Agents; Studies; Thailand; Urogenital System; Uterus; Vagina; Vaginal Abnormalities; Vaginal Desquamate Effects; Vaginal Spermicides; Vaginal Suppository; Vaginitis
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Year: 1991 PMID： 1658953 DOI： 10.1097/00007435-199107000-00010
Source DB: PubMed Journal: Sex Transm Dis ISSN： 0148-5717 Impact factor: 2.830