[Contraceptive efficacy of bioadhesive nonoxynol-9 Gel: comparison with nonoxynol-9 suppository]. 2003

Jin-xun Xu, and Lin-te Shi, and Xiao-bo Zhou, and Zhi-qin Xiao
Science and Technology Division, Shanghai Municipal Commission of Population and Family Planning, Shanghai 200002, China.

OBJECTIVE To compare the contraceptive efficacy of a new spermicide, bioadhesive nonoxynol (N-9) gel, with a traditional N-9 suppository. METHODS A total of 240 child-bearing aged woman volunteers were randomly divided into two groups: 120 cases using the gel for contraception, and another 120 using the suppository. Using lifetable method and log rank test, we compared the pregnancy rates and other discontinuation rates after follow-up for 6 months in two groups. RESULTS No abnormal findings of cervical smears were detected before and after this clinical trial in all 240 women. The follow-up rates at 6 months were 100.0% and 97.5% in the gel group and the suppository group, respectively. The 6-month gross cumulative pregnancy rates of typical use were 6.39 and 2.95 per 100 women (P > 0.05), respectively. If we eliminated the 5 pregnancy women (3 in the gel group, and 2 in the suppository one), who did not consistently use the spermisides for every intercourse, the cumulative pregnancy rates at 6 month in perfect use would be 3.71 and 2.03 (P > 0.05). And the discontinuation rates due to allergy or other side effects at 6 months in typical use were 3.45 and 4.57 (P > 0.05), respectively. All of the results observed between two groups in this study were not statistically significant. CONCLUSIONS The contraceptive efficacy of bioadhesive N-9 gel is as same as that of the N-9 suppository, and its clinical use is quite safe.

UI MeSH Term Description Entries
D003271 Contraceptive Agents, Female Chemical substances or agents with contraceptive activity in females. Use for female contraceptive agents in general or for which there is no specific heading. Contraceptives, Female,Agents, Female Contraceptive,Female Contraceptive Agents,Female Contraceptives
D005260 Female Females
D005782 Gels Colloids with a solid continuous phase and liquid as the dispersed phase; gels may be unstable when, due to temperature or other cause, the solid phase liquefies; the resulting colloid is called a sol.
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D013089 Spermatocidal Agents Chemical substances that are destructive to spermatozoa used as topically administered vaginal contraceptives. Spermicidal Agents,Contraceptive Agents, Spermatocidal,Spermatocidal Drugs,Spermatocides,Spermicidal Contraceptive Agents,Vaginal Spermicides,Agents, Spermatocidal,Agents, Spermatocidal Contraceptive,Agents, Spermicidal,Agents, Spermicidal Contraceptive,Contraceptive Agents, Spermicidal,Drugs, Spermatocidal,Spermatocidal Contraceptive Agents,Spermicides, Vaginal
D013488 Suppositories Medicated dosage forms that are designed to be inserted into the rectal, vaginal, or urethral orifice of the body for absorption. Generally, the active ingredients are packaged in dosage forms containing fatty bases such as cocoa butter, hydrogenated oil, or glycerogelatin that are solid at room temperature but melt or dissolve at body temperature. Rectal Suppositories,Vaginal Suppositories,Vaginal Suppository,Suppositories, Rectal,Suppositories, Vaginal,Suppository, Vaginal
D017060 Patient Satisfaction The degree to which the individual regards the health care service or product or the manner in which it is delivered by the provider as useful, effective, or beneficial. Satisfaction, Patient
D017137 Nonoxynol Nonionic surfactant mixtures varying in the number of repeating ethoxy (oxy-1,2-ethanediyl) groups. They are used as detergents, emulsifiers, wetting agents, defoaming agents, etc. Nonoxynol-9, the compound with 9 repeating ethoxy groups, is a spermatocide, formulated primarily as a component of vaginal foams and creams. Nonylphenoxypolyethoxyethanols,Advantage-S,Delfen Cream,Emulgen 911,Emulgin 913,Nonoxinol,Nonoxinols,Nonoxynol, 1(4)-Sulfate, Sodium Salt,Nonoxynol, 4-Sulfate, Ammonium Salt,Nonoxynol-9,Nonoxynols,Nonylphenoxypolyethoxyethanol,Patentex Oval,Advantage S,Delfen Creams,Nonoxynol 9,Oval, Patentex

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