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PubMed1988

A clinical trial of nonoxynol-9 for preventing gonococcal and chlamydial infections.

A randomized, double-blind, placebo-controlled trial was conducted to evaluate the spermicidal agent nonoxynol-9 as prophylaxis for cervical infections caused by Chlamydia trachomatis and Neisseria gonorrhoeae. Eight hundred eighteen women were recruited from a sexually transmitted disease clinic. Only subjects who were using reliable birth control methods (oral contraceptives, intrauterine device, or sterilization) were eligible. Subjects were randomly assigned to use either a commercially available spermicidal agent containing nonoxynol-9 or a placebo preparation. Subjects were followed up for six months; specimens were collected monthly for culture of the two pathogens. Women assigned to the nonoxynol-9 group were less likely to become infected with N. gonorrhoeae (relative rate, 0.75; 90% confidence limits, 0.58 and 0.96) and C. trachomatis (relative rate, 0.79; 90% confidence limits, 0.64 and 0.97). Among women who used their assigned gel for the majority of coital episodes, a stronger protective effect was observed.

Adult↗
PubMed1980

Studies on nonoxynol-9. III. Effect on fibroblasts and spermatozoa.

Seven nonionic detergents of the Igepal CO series differing in molecular size and including nonoxynol-9 and a representative anionic (SDS) and cationic (Cepacol) detergent were tested as to their relative cytotoxicity. The biologic effects of these detergents on human W1--38 fibroblasts (DNA and glycosaminoglycans synthesis) and on the motility of human spermatozoa were studied. The relative order of cytotoxicities for both fibroblasts and spermatozoa was cationic greater than nonionic greater than anionic. The concentration of nonoxynol-9-inhibiting fibroblast activity was approximately 30 times less than the amount needed to immobilize spermatozoa. It is concluded that CO-630, used as a source of nonoxynol-9, is the most effective polymer to inhibit spermatozoa and also fibroblasts.

Anions↗
PubMed1982

Transvaginal absorption and disposition of nonoxynol-9 in gravid rats.

The placental transfer, maternal tissue distribution and elimination of [14C]-nonoxynol-9 (25 mg/kg) were studied during the first 6 h in 15-day pregnant rats treated intravaginally. Blood concentrations of 14C reached a maximum of 2.0 +/- 0.06 micrograms/ml in 1 h, declining slowly in 3 h, and remaining steady thereafter. At 6 h, the highest levels of 14C were recorded in the maternal urinary bladder, followed by those in the liver, kidney, adrenal and thyroid. The maternal brain showed lowest uptake of 14C among all tissues examined. After 6 h, the 14C concentrations in the uterus or placenta were similar to that of maternal plasma, whereas the mean concentrations of 14C both in the amniotic fluid and fetus were approx. one-third of that of the maternal plasma. About 44% of the administered dose was absorbed from the vagina, and nearly 17% of the per vaginum applied radioactivity was recovered in the urine and feces over 6 h. The results show that nonoxynol-9 (N-9) is rapidly absorbed into the blood stream from the vagina of gravid rat and that the fetal uptake of 14C is much lower than that of the placenta.

Absorption↗
PubMed1994

Comparative in vitro study of contraceptive agents with anti-HIV activity: gramicidin, nonoxynol-9, and gossypol.

Gramicidin, a polypeptide antibiotic derived from Bacillus brevis, was compared in vitro with the established contraceptive virucidal agents nonoxynol-9 and gossypol for activity against human immunodeficiency virus (HIV) infection. The effective antiviral 10 ng/ml concentration of gramicidin required for complete HIV inactivation was a thousand-fold lower than the dose observed for nonoxynol-9 or gossypol. Gramicidin, routinely used as a contraceptive agent in the former Soviet Union, should be considered for in vivo trials as a spermicide with potent antiviral activity.

Antiviral Agents↗
PubMed1995

Complementary effects of propranolol and nonoxynol-9 upon human sperm motility.

The inhibitory effects of nonoxynol-9, DL- and D-propranolol upon human sperm motility were determined in vitro. All three compounds were capable of causing complete cessation of sperm movement. However, greater efficacy was achieved using combinations of nonoxynol-9 and propranolol, suggesting a complementary interaction between these compounds. Investigations of the mechanism of action of propranolol revealed that an influx of calcium accompanied the loss of motility. However, since incubation in the absence of calcium enhanced the spermicidal effects of this compound, it was concluded that this calcium influx did not constitute the primary means by which motility was disrupted. Low doses of propranolol, which did not affect motility, were found to inhibit the capacity of human spermatozoa for sperm-oocyte fusion.

Calcium↗
PubMed1998

Dose-response effects of gramicidin-D, EDTA, and nonoxynol-9 on sperm motion parameters and acrosome status.

Previous reports showed that gramicidin-D (G-D), a polypeptide with antiviral and antimicrobial properties, nonoxynol-9 (N9), a common spermicidal detergent, and EDTA, a Ca-Mg chelating agent, inhibited sperm motility and cervical mucus penetration. The purpose of this study was to determine the dose-response effects of G-D, N9, EDTA and G-D + EDTA on sperm motion parameters and acrosome status. Semen specimens from known fertile donors were subjected to computer-assisted semen analysis of motility, path velocity, progressive velocity, and hyperactivation prior to and after incubation with varying concentrations of gramicidin-D, EDTA and nonoxynol-9. Each specimen was also prepared for acrosome status using rhodamine isothiocyanate conjugated pisum sativum agglutinin (RITC-PSA). There was a significant decrease in motility by G-D, EDTA, G-D + EDTA, and N9 at all doses as compared to the fresh specimen. N9 completely immobilized all sperm at each dose. Progressive velocity and path velocity also decreased in a dose-response manner. Sperm hyperactive motility also significantly decreased in all groups. The majority of sperm remained acrosome intact following exposure to all doses tested, whereas N9 resulted in complete breakdown/release of the acrosomal contents. This study confirms previous reports that G-D, EDTA, and N9 significantly impair sperm motility and motion parameters. The effective 100% inhibitory concentration was seen only with N9, whereas G-D, EDTA, and G-D + EDTA resulted in incomplete impairment of sperm motion parameters. At the concentrations used, N9 demonstrated potent spermostatic activity. Gramicidin-D and EDTA should be further studied for their potential contraceptive spermostatic activity.

Acrosome↗
PubMedDate not supplied

The spermicide nonoxynol-9 does not inactivate papillomavirus.

Vaginal spermicides are effective contraceptive, and are also capable of inactivating many sexually transmitted pathogens by their detergent effect on bacterial cell membranes and viral envelopes. A 5% concentration of nonoxynol-9, the most frequently used active ingredient of spermicides, was tested for its ability to reduce the transforming activity of bovine papillomavirus type 1 (BPV-1), and the infectivity of BK virus (BKV) and cytomegalovirus (CMV). Nonoxynol-9 markedly reduced the infectivity of CMV, an enveloped virus, but did not significantly affect the activity of the nonenveloped viruses BPV-1 and BKV. Papillomavirus infections are strongly implicated in the etiology of cervical cancer. The reported protective effect of vaginal spermicides against cervical cancer is very likely not mediated by direct inactivation of papillomaviruses by the spermicide.

Animals↗
PubMed1990

Comparative effects of (+)-propranolol and nonoxynol-9 on human sperm motility in-vitro.

Using the modified transmembrane migration method to measure sperm motility, it was shown that the surfactant nonoxynol-9 alone, was twice as potent as (+)-propranolol alone as a spermicidal agent. Addition of (+)-propranolol to nonoxynol-9 shifted the dose-response curve to the left of the curves for either component alone, and a surprising synergistic action was evident. These observations may form the basis for the development of a new advantageous topical contraceptive combination product.

Dose-Response Relationship, Drug↗
PubMed2002

Nonoxynol-9 for preventing vaginal acquisition of HIV infection by women from men.

BACKGROUND: There is a need for female-controlled methods of HIV prevention. Vaginal microbicides, substances inserted into the vagina to prevent women acquiring HIV and sexually transmitted infections (STIs) from men, could be useful in this regard. One potential vaginal microbicide is the widely used spermicide, nonoxynol-9 (N-9). OBJECTIVES: To determine the safety and effectiveness of N-9 in preventing vaginal acquisition of HIV infection by women from men. SEARCH STRATEGY: Extensive searches of electronic databases, conference abstracts, reference lists of relevant studies and contact with experts and funders. SELECTION CRITERIA: Randomised controlled trials meeting pre-determined quality criteria with HIV infection as the outcome. DATA COLLECTION AND ANALYSIS: Data were extracted by one reviewer and checked by the another. Any discrepancies were adjudicated by a third reviewer. MAIN RESULTS: Five trials were included in the review and four contributed to a meta-analysis. Overall, the risk of HIV infection was not statistically significantly different among women receiving N-9 (relative risk [RR] 1.12, 95% CI 0.88-1.42; p=0.4). The risk of genital lesions was statistically significantly greater among women receiving N-9 (RR 1.18, 95%CI 1.02-1.36; p=0.02). REVIEWER'S CONCLUSIONS: There is no evidence that nonoxynol-9 protects against vaginal acquisition of HIV infection by women from men. There is evidence that it may do harm by increasing the frequency of genital lesions.

Coitus↗
PubMed2002

Nonoxynol-9 for preventing vaginal acquisition of sexually transmitted infections by women from men.

BACKGROUND: The incidence and prevalence of sexually transmitted infections (STI) and other reproductive tract infections (RTI) is high in much of the developing and parts of the developed worlds. STIs and RTIs are associated with the vaginal transmission of HIV. Additional strategies to improve STI control are needed, and vaginal microbicides are a possible strategy. One potential vaginal microbicide is the widely used spermicide, nonoxynol-9 (N-9). OBJECTIVES: To determine the safety and effectiveness of N-9 in preventing vaginal acquisition of sexual transmitted infections (exclusive of HIV) by women from men. SEARCH STRATEGY: Systematic search of electronic databases, conference abstracts, reference lists of relevant studies and contact with experts and funders. SELECTION CRITERIA: Randomised controlled trials meeting pre-determined quality criteria with STI as the outcome. DATA COLLECTION AND ANALYSIS: Data were extracted by one reviewer and checked by another. MAIN RESULTS: Ten of 12 identified randomised controlled trials were included and findings among them were broadly consistent. In meta-analysis, the risks of gonorrhoea (relative risk [RR] 0.91, 95%CI 0.67-1.24), cervical infection (RR 1.01, 0.84-1.22), trichomoniasis (RR 0.84, 0.69-1.02), bacterial vaginosis (0.88, 0.74-1.04), chlamydia (RR 0.88, 0.77-1.01) and candidiasis (RR 0.97, 0.84-1.12) were not statistically significantly different in women receiving N-9 compared with placebo. Genital lesions were more common in the N-9 users (RR 1.17, 95%CI 1.02-1.35). REVIEWER'S CONCLUSIONS: There is good evidence that nonoxynol-9 does not protect against sexually transmitted infections, and there is some evidence that it may be harmful by increasing the rate of genital ulceration. As such, this product cannot be recommended for STI prevention.

Female↗
PubMed1988

In vitro BALB/3T3 cell transformation assay of nonoxynol-9 and 1,4-dioxane.

The spermicidal surfactant nonoxynol-9 (Igepal CO-630, GAF Corp.) and a potential impurity, 1,4-dioxane, were tested in the in vitro cell transformation assay using BALB/3T3 cells. Two treatment periods, 48 hr and 13 days, were used. Nonoxynol-9, tested at levels up to 10 micrograms/ml, did not induce transformation, whereas dioxane was very active in the induction of type III foci in the cultured BALB/3T3 cells.

Animals↗
PubMed1985

A comparison of the effects of nonoxynol-9 and chlorhexidine on sperm motility.

The effects of Nonoxynol-9 and chlorhexidine on sperm motility were compared using the objective Transmembrane Migration Ratio method. These agents were found to be of similar potency in inhibiting sperm motility. The concentrations which reduced sperm motility by 50% (EC50) were 0.205 mg/ml for Nonoxynol-9 and 0.215 mg/ml for chlorhexidine. The implications of these findings in relation to the comparison of the effects of drugs on sperm motility and the development of new contraceptive agents are discussed.

Chlorhexidine↗
PubMed1986

Comparison of the spermicidal activity and acute toxicity of nonoxynol-9 and agent 741 [alkylphenoxy polyethoxy ethanol(10)].

A spermicidal agent called "741" is used in the People's Republic of China as a substitute for nonoxynol-9 in vaginal contraceptive preparations. The relative spermicidal activity of these two agents was evaluated using dog, rabbit, monkey and human semen. Acute LD50 determinations in mice were also performed. The spermicidal activity and acute toxicity of both agents were either identical or very similar in all species. Since agent 741 is less expensive than nonoxynol-9 to manufacture and equally as potent in vitro, it is an alternative spermicide for vaginal contraceptive formulations.

Animals↗
PubMed1988

Inhibition of sperm migration, fertilization and implantation in rats by precoital intrauterine administration of gossypol or nonoxynol-9.

The effects of precoital intrauterine administration of Gossypol, Nonoxynol-9 or p-Aminobenzamidine on reproductive function were investigated in rats. The drugs were instilled in one uterine horn in the evening of proestrus prior to caging with a fertile male. The opposite side was similarly treated with the vehicle and served as control. Animals were killed in the morning following mating to assess the number of spermatozoa at the site of fertilization or on days 2-3 of pregnancy to determine the proportion of penetrated oocytes or on day 12 to count implanted embryos. Gossypol 0.05 to 5 mg or Nonoxynol-9 0.1 - 10 microliter reduced the number of spermatozoa reaching the ampullae and the number of penetrated oocytes in a dose-dependent fashion. At the highest dose both compounds prevented pregnancy exclusively in the treated side. p-Aminobenzamidine at a dose of 10 mg failed to affect the proportion of penetrated eggs found on days 2 or 3 of pregnancy. The results indicate that the rat bioassay is suitable to screen agents that can affect sperm function or viability since it can discriminate between drugs and doses and disclose differential effects upon sperm migration and fertilizing capacity.

Animals↗
PubMed1992

Comparative in vitro study of nonoxynol-9: effects on human, bull and boar spermatozoa.

Spermicidal activity of different dilutions of nonoxynol-9 (nonyl-phenoxy-polyethoxy-ethanol) on human, bull and boar spermatozoa was studied using the modified Sander-Cramer method. The results obtained showed that differences in spermatozoal resistance among the mentioned species to nonoxynol-9 were statistically very significant (P much less than 0.0005): bull greater than man greater than boar. The results obtained were compared to available literature results.

Analysis of Variance↗
PubMed1988

Disposition of [14C]nonoxynol-9 after intravenous or vaginal administration to female Sprague-Dawley rats.

The disposition of nonoxynol-9 labeled with carbon-14 at the ethylene oxide units was studied following an iv or vaginal administration to female Sprague-Dawley rats. The results from the vaginal administration studies indicate 12.8% absorption of 14C radioactivity in 6.0 hr and 37.7% in 24.0 hr. Tissue distribution studies showed that the small and large intestines, including their contents, had the highest 14C activity by either route of administration. Radiomonitored HPLC of bile collected at 6.0 hr and urine at 6.0, 24.0, and 48.0 hr following an iv injection of [14C]nonoxynol-9 showed that the compound was completely metabolized in the body of the rat. The metabolites were primarily excreted in the feces and secondarily in the urine. Analysis of urinary metabolites containing the carbon-14 label, 6.0 hr following an iv dose, indicated the presence of highly polar neutral (53.27%) and acidic (39.23%) species.

Administration, Intravaginal↗
PubMed1985

Comparison of the sensitivity of the vaginal mucous membranes of the albino rabbit and laboratory rat to nonoxynol-9.

Studies were conducted to compare the sensitivities of the vaginal mucous membranes of the albino rabbit and albino rat to irritation by the surfactant nonoxynol-9. The purpose of this comparison was to evaluate the rat as a model for screening vaginal products for their potential irritancy. Nonoxynol-9 at various concentrations in distilled water was administered intravaginally by lavage once a day for four consecutive days. On day 5, the animals were killed and the vaginal tissues were processed and examined histopathologically. Using a predetermined semiquantitative scoring system, it was found that the intensity of irritation was concentration dependent in both species. In the rabbit, the irritation was significantly greater than that in the rat, being mild with concentrations of 2.5 and 5% and moderate to severe at 12.5 and 25%. In the rat, irritation was negligible up to 12.5%, becoming mild at 25% and more moderate at 75%. Thus the vaginal mucosa of the rabbit is more sensitive than that of the rat and may be expected to give a more exaggerated representation of the irritation potential of a compound to the human vagina than would the rat mucosa.

Animals↗
PubMed1990

Preparative liquid chromatographic separation of the oligomers of nonoxynol-9 and their characterization by 1H-NMR and mass spectroscopy.

Conditions are described for the preparative LC separation of a bulk nonoxynol-9 material into 16 components. 1H-NMR analyses of these fractions provided evidence for all but the first of the components to be oligomers of nonylphenoxypolyethoxyethanol (nonoxynol) with n-values for (OCH2CH2)n ranging consecutively from 3 to 17, corresponding to the LC fractions 2-16. Mass spectral analysis of the separated LC fractions confirmed the oligomeric sizes deduced from 1H-NMR spectral data, and provided EI fragmentation information for these oligomeric substances.

Chromatography, Liquid↗