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PubMed2000

A randomized trial of intravaginal nonoxynol 9 versus oral metronidazole in the treatment of vaginal trichomoniasis.

OBJECTIVE: This study was undertaken to investigate the efficacy of nonoxynol 9 suppositories in the treatment of vaginal trichomoniasis. STUDY DESIGN: In this prospective comparison trial 46 women with documented motile trichomonads found on a wet preparation were randomly assigned to one of two treatment arms: (1) a single oral dose of 2 g metronidazole and (2) a single 150-mg nonoxynol 9 suppository placed intravaginally for 3 consecutive nights. Cure was determined by a repeated wet preparation examination. After its first year, the study was terminated because of the poor efficacy of the nonoxynol 9 suppositories. RESULTS: Results were available for 33 patients. Three of 17 patients treated with nonoxynol 9 had negative wet preparation results at retest (17.6% cure rate). All 16 patients treated with metronidazole had negative wet preparation results (100% cure rate). All women with nonoxynol 9 failures who were evaluated after treatment with 2 g metronidazole had negative wet preparation results. CONCLUSION: Intravaginal nonoxynol 9 at the tested dose and by the tested method of delivery was not an effective cure for vaginal trichomoniasis.

Administration, Intravaginal↗
PubMed1992

Effects of the spermicidal agent nonoxynol-9 on vaginal microbial flora.

The use of nonoxynol-9--containing vaginal contraceptive preparations increases vaginal (and urethral) colonization by Escherichia coli. Nonoxynol-9 is toxic to various microorganisms, including Lactobacillus acidophilus, but has little or no direct effect on E. coli. L. acidophilus, which is present in the vaginas of most normal women, generates H2O2 which, when combined with peroxidase and a halide, was toxic to E. coli. This toxicity was inhibited by nonoxynol-9 due to the selective destruction of the lactobacilli. In contrast, at higher concentrations, nonoxynol-9 was toxic to E. coli when combined with peroxidase and a halide. This toxicity was shared with certain other nonionic detergents and was due to the formation of peroxides in the preparations on prolonged exposure to oxygen. E. coli colonization may, in part, reflect the balance between these opposing effects of nonoxynol-9 on the vaginal antimicrobial system. Further, damage to normal tissues by peroxides in nonoxynol-9 preparations needs to be considered.

Chlorides↗
PubMed1999

Phase 1 trial of nonoxynol-9 film among sex workers in South Africa.

OBJECTIVES: To assess the acceptability and safety of a vaginal nonoxynol-9 film in a group of sex workers at a truck stop in South Africa. DESIGN: A randomized double-blinded crossover trial was conducted between April 1995 and July 1995. INTERVENTION: Seventy-two mg nonoxynol-9 film and an identical glycerine placebo film. METHODS: Following informed consent, each study participant was randomly assigned the designated pre-coded film for 1 month. The second month was a film-free washout period and the participants used the alternate film in the third month. Besides measuring behavioural and clinical outcomes, colposcopy examination for genital lesions, serology and microbiology investigations for sexually transmitted diseases and semi-quantitative PCR for vaginal HIV load estimates were performed. RESULTS: Twenty women participated in the study. The women reported, on average, 19 sexual encounters per week. Vaginal intercourse was protected 25% of the time by condoms. On average, 11 vaginal films, either nonoxynol-9 or placebos were inserted per week. There were no statistically significant differences between the two treatment groups for genital lesions (P = 0.29), reported side effects (P = 0.73), and viral load (P = 0.9). However, the proportions of clinically detected genital lesions (six out of eight versus two out of eight) and self-reported side-effects (five out of eight versus three out of eight) were higher in the nonoxynol-9 group when compared with the placebo group. Incident sexually transmitted diseases occurred more frequently in the placebo group. An increased viral load was associated with the development of a genital lesion (relative risk, 6.0; 95% confidence interval, 0.81-44.4). CONCLUSIONS: The 72 mg film formulation of nonoxynol-9 was an acceptable product for use in this population of sex workers. Although no statistically significant differences in adverse outcomes were detected, clinically there appeared to be an increase in minor lesions and self-reported side-effects with nonoxynol-9 and less protection against sexually transmitted diseases with the placebo. Furthermore, HIV shedding was correlated with the presence of incident vaginal or cervical lesions. This brings into question the potential narrow margin of safety for this product; additional Phase 2 studies are therefore required.

Administration, Intravaginal↗
PubMedDate not supplied

In vitro activity of nonoxynol-9 on McCoy cells infected with Chlamydia trachomatis.

Nonoxynol-9, a nonionic detergent and active ingredient in spermicidal contraceptives, has been reported to have anti-chlamydial properties. However, in this study exposure of elementary bodies of Chlamydia trachomatis serovar E to nonoxynol-9 (12.5-10,000 micrograms/ml) had no effect on chlamydial infectivity. In contrast, uninfected McCoy cells incubated with increasing concentrations of nonoxynol-9 over 72 h displayed dose-related cytotoxicity. When infected McCoy cells were exposed to nonoxynol-9, the developing chlamydial inclusions did not stain with iodine even though they were similar in number and appearance to the inclusions in unexposed, infected monolayers. Transmission electron microscopy of nonoxynol-treated, infected cells revealed apparent damage to the inclusion membrane and reticulate bodies within. The infectivity of the chlamydiae in the iodine-negative inclusions on subpassage was only 0.3%. We conclude that the primary action of nonoxynol-9 is on the McCoy cell and that there may be secondary effects on the intracellular parasite.

Cells, Cultured↗
PubMed1987

Bioelectric activity as a quantifiable index of acute spermicide (nonoxynol-9) actions on rat vaginal epithelial function during the oestrous cycle.

The acute effect of instillation of the spermicide 2% nonylphenoxypolyethoxyethanol (nonoxynol-9) on the bioelectric activity of the vaginal epithelium was assessed using as an index the time taken in seconds to reduce the transvaginal potential difference (p.d.), measured in anaesthetised rats, to half its initial value (t1/2). The surfactant caused rapid falls in the p.d. at dioestrus (t1/2 = 35 +/- 25 sec., n = 16, mean +/- S.D.) and metoestrus (t1/2 = 32 +/- 27 sec., n = 11) with a slower fall at oestrus (t1/2 = 130 +/- 104 sec., n = 14). At pro-oestrus however, nonoxynol-9 had no effect (n = 18). The dye Nigrosin (0.5%), when instilled alone, did not stain untreated vaginas of anaesthetized rats at any stage of the oestrous cycle, but in the presence of 2% nonoxynol-9 heavily stained those in metoestrus and dioestrus. Vaginas in pro-oestrus were unstained while those in oestrus were stained lightly. While nonoxynol-9 has a dramatic effect on the bioelectric activity of the vaginal epithelium, both the electrical and dye data show that the pro-oestrus vaginal epithelium presents a significant diffusion barrier to the passage of nonoxynol-9 and nigrosin. Thus, in assessing the actions of vaginally instilled nonoxynol-9 in rats the variation in the permeability of the vaginal epithelium during the oestrous cycle must be taken into account.

Aniline Compounds↗
PubMed1988

A modified transmembrane migration method for evaluating the spermicidal potency of some nonoxynol compounds.

The transmembrane migration technique, a simple method in-vitro for quantitatively assessing the effects of a drug on human sperm motility, has been evaluated. The original method has been modified to include a preincubation step, and the incubation time has been reduced to 90 min. In semen samples possessing sperm concentrations of less than 75 x 12(6) spermatozoa mL-1 the volume of the lower reservoir has been reduced to 1 mL. This modified method has been used to compare the spermicidal potency of the widely employed non-ionic surfactant nonoxynol-9, with nonoxynol-5 and nonoxynol-15 (containing, respectively, fewer and more ethylene oxide units per molecule). The rank order of spermicidal potency of the compounds evaluated was nonoxynol-9 = nonoxynol-5 greater than nonoxynol-15.

Humans↗
PubMed1990

Evaluation of the amount of nonoxynol available in condoms for the inhibition of HIV using a method based on HPLC.

A method is described for detection of nonoxynol in condoms, based on methanol-water extraction followed by reverse-phase high-performance liquid chromatography. Using this method, we found that approximately 50% of the nonionic surfactant lubricant nonoxynol migrated into elastomers (rubber latex), resulting in a concentration of nonoxynol insufficient to inhibit human immunodeficiency virus (HIV) (less than 0.05%). In order to minimize the risk of sexual transmission of HIV, and to ensure spermicidal effect and optimal rubber properties, the concentration of nonoxynol in condoms, therefore, should either be increased, or nonoxynol should be packed separately. Further studies are needed to clarify and determine the solubility and migration of nonoxynols into elastomers.

Biological Availability↗
PubMed1994

The use of nonoxynol-9 for protection against cervical gonorrhea.

OBJECTIVES: Although condoms are the best defense against sexually transmitted disease, little is known about the effectiveness of female-controlled methods containing nonoxynol-9 as backup protection when condoms are not being used. METHODS: To assess the extent to which nonoxynol-9 protects women against gonorrhea, a cohort of 303 female sex workers (prostitutes) in Yaounde, Cameroon, were asked to use condoms and suppositories containing nonoxynol-9 at every sexual encounter and to record daily sexual activity and use of condoms and suppositories on coital logs that were reviewed monthly. Evidence of gonorrheal infection was based on a positive gonorrhea culture. Stratified analysis and proportional hazards regression were used to estimate rate ratios. RESULTS: Forty-one women enrolled in the study were excluded from the current analysis. The estimated incidence of gonorrhea was 6.2 infections per 100 person-months of observation. Incidence rate ratios estimated from proportional hazards regression models controlling for condom use showed that using nonoxynol-9 during acts not protected by condoms reduced the risk of infection. CONCLUSIONS: Although the protective effect of condoms against sexually transmitted disease is greater than that afforded by nonoxynol-9, using nonoxynol-9 when condoms are not used is a far better strategy in gonorrhea prevention than using no method at all.

Administration, Intravaginal↗
PubMed2003

Phase I safety & preliminary acceptability of nonoxynol-9 vaginal pessary as a vaginal microbicide in low risk women in Pune, India.

BACKGROUND & OBJECTIVES: Though nonoxynol-9 (N-9) is available in India as a spermicidal pessary, data on its safety as a potential microbicide among Indian women are not available. Nonoxynol-9 containing compounds have shown anti-HIV activity in in vitro studies and protection against cervical infections. Nonoxynol-9 is being extensively evaluated as a vaginal microbicide world-wide. We assessed the safety and preliminary acceptability of nonoxynol-9 pessary as a vaginal microbicide in women at low risk for human immunodeficiency virus (HIV) infection and sexually transmitted diseases (STDs). METHODS: Twenty three HIV seronegative women enrolled in the study were given Today pessarys containing 5 per cent of nonoxynol-9 for vaginal use at bedtime for 14 days. Colposcopy was done at enrollment and on day 14 and speculum examination on day 7 to assess the local toxicity. RESULTS: Most of the women (16/23, 69.6%) did not experience any symptoms of genital irritation. The remaining 7 (30.4%, 95% CI 11.6-49.2) women reported 11 episodes of mild irritative symptoms of short duration. On clinical examination, three adverse events were reported of which one could have been product related. Eight (34.8%) women showed willingness to use the product for protection against HIV transmission if it was approved. INTERPRETATION & CONCLUSION: Nonoxynol-9 vaginal pessary was found to be safe and acceptable in once daily dose in low risk women after consecutive use for 14 days. Willingness for future use, if found safe and effective for HIV prevention was shown by 8 (34.8%) women.

Administration, Intravaginal↗
PubMed1998

Diffusion of nonoxynol-9 into human semen in vitro.

The diffusion of [125I]-nonoxynol-9 into human semen was investigated in vitro before and after liquefaction. No significant difference was found in the distribution of [125I]-nonoxynol-9 within columns of preliquefied semen, liquefied semen, seminal plasma, or water after < or = 120 minutes of diffusion; however, significantly more nonoxynol-9 entered preliquefied semen. The concentration of nonoxynol-9 that entered semen in vitro was greater than its ED100 and the bioavailability was confirmed by demonstration of the retention of spermicidal action. These results indicate that the gel state of preliquefied semen does not inhibit the entry or action of nonoxynol-9 and, consequently, sperm would be exposed to it immediately when it is used in vivo as a vaginal spermicide.

Adult↗
PubMed1998

Do spermicides containing nonoxynol-9 prevent sexually transmitted infections? A meta-analysis.

BACKGROUND AND OBJECTIVES: There are conflicting opinions on whether to recommend spermicides containing nonoxynol-9 for prevention of sexually transmitted diseases, including human immunodeficiency virus (HIV). GOAL: To systematically review and summarize the medical literature on the effect of spermicides containing nonoxynol-9 on prevention of gonorrhea, chlamydial infection, and HIV. STUDY DESIGN: Meta-analysis. Potential articles were identified through computerized literature searches. Articles were included if the design was clinical trial, cohort, case-control, or cross-sectional; original outcome data were presented for gonorrhea, chlamydial infection, or HIV; and spermicides containing nonoxynol-9 were used separately from other barrier methods. Study characteristics including design, population, spermicide dose, and delivery method were abstracted. Relative risks (RR) and 95% confidence intervals (CI) were determined from information published in the study or from study authors. Summary risk estimates were computed for clinical trials. RESULTS: Twelve eligible articles were identified, including six clinical trials and six observational studies. Eleven articles evaluated gonorrhea; each found a reduced risk of infection with spermicide use. Among six clinical trials, the summary RR was 0.62 (95% CI, 0.49-0.78). The five articles evaluating chlamydial infection also found significant reduction among spermicide users, with the four clinical trials having a summary RR of 0.75 (95% CI, 0.62-0.91). The degree of spermicidal protection against gonorrhea and chlamydial infection did not differ materially among studies with different study designs or spermicidal preparations (i.e., sponge, gel, suppository, or film). Three studies evaluated degree of protection according to consistency of use and found stronger protection with more consistent use. The two studies on spermicidal prevention of HIV had contrasting results: An observational study found a significant protective effect (RR = 0.1), whereas a clinical trial found a nonsignificantly increased risk (RR = 1.7). CONCLUSIONS: Nonoxynol-9-containing spermicides have an appreciable protective effect against both gonorrhea and chlamydial infection, and wider use of spermicides might substantially reduce the incidence of these diseases. However, insufficient data exist to judge their effect on HIV transmission, and more research on the effect of nonoxynol-9 on HIV transmission is urgently needed to make evidence-based clinical decisions and public health recommendations in the future.

Chlamydia Infections↗
PubMed1999

Duration of vaginal retention and potential duration of antiviral activity for five nonoxynol-9 containing intravaginal contraceptives.

OBJECTIVE: The purpose of this study was to determine the vaginal retention of five nonoxynol-9 intravaginal contraceptives. METHOD: An open-label crossover study in 10 premenopausal volunteers was performed at an outpatient clinical research center. The outcomes are described utilizing the median and range. RESULT: At 8 h post-instillation, the median amounts of nonoxynol-9 present in the vagina were: Delfon 7.68 mg, Conceptrol 5.18 mg, Advantage 24 1.95 mg, VCF 1.74 mg, and Semicid 1.51 mg respectively. Our calculated theoretical minimal amount needed to protect against HIV infection is 2.00 mg. CONCLUSION: The best vehicle for retaining nonoxynol-9 in the vagina appears to be foam. Further research in the effectiveness of nonoxynol-9 in prevention of the spread of HIV infection should be directed toward the use of foam vehicles to deliver nonoxynol-9 to the vagina.

Administration, Intravaginal↗
PubMed2003

In vitro release of nonoxynol-9 from silicone matrix intravaginal rings.

The controlled-release characteristics of matrix silicone intravaginal rings loaded with between 100 and 971 mg of nonoxynol-9 have been investigated with a view to developing a ring that may offer a new female-controlled method for the prevention of transmission of sexually transmitted diseases, particularly HIV. Intravaginal rings containing 253, 487 and 971 mg of nonoxynol-9 provided a daily release of 2 mg or more over the 8-day release period, the minimal amount of nonoxynol-9 considered to provide an effective vaginal concentration for the prevention of HIV. Furthermore, the maximum daily release of N9 was about 6 mg, an amount significantly smaller than that observed for other nonoxynol-9 products whose large daily doses may in fact increase the occurrence of HIV by causing epithelial damage to the vaginal tissue. The release mechanism of the liquid nonoxynol-9 from the intravaginal rings has also been investigated and compared to models describing the release of solid drugs from the rings. It has been demonstrated through release studies and surface microscopy that a drug depletion zone is not established in such liquid-loaded intravaginal ring systems, with implications for the release kinetics.

Contraceptive Devices, Female↗
PubMed2002

WHO/CONRAD technical consultation on nonoxynol-9, World Health Organization, Geneva, 9-10 October 2001: summary report.

This report summarises the evidence presented to a technical consultation on the safety of N-9 and its effectiveness for protection against pregnancy, sexually transmitted infections and HIV, organized by the World Health Organization Department of Reproductive Health and Research with CONRAD in October 2001. Key conclusions from the meeting include: 1. Although Nonoxynol-9 has been shown to increase the risk of HIV infection when used frequently by women at high risk of infection, it remains a contraceptive option for women at low risk. 2. Nonoxynol-9 offers no protection against sexually transmitted infections such as gonorrhoea or chlamydia. 3. There is no evidence that condoms lubricated with nonoxynol-9 are any more effective in preventing pregnancy or infection than condoms lubricated with silicone, and such condoms should no longer be promoted. However, it is better to use a nonoxynol-9 lubricated condom than no condom at all. 4. Nonoxynol-9 should not be used rectally.

Animals↗
PubMed2002

Synthesis of novel iodinated derivatives of nonoxynol-9 and their bioavailability in rats.

The absorption and distribution of iodinated derivatives of nonoxynol-9, after vaginal administration in rats, were compared with results reported for [14C] nonoxynol-9. Mono-iodinated nonoxynol-9 was synthesized in addition to the radiolabeled derivative incorporating iodide-125 ([125I]). Six hours after dosing, test rats were euthanized and selected tissues were excised and assessed for radioactivity. Levels of radioactive markers in the reproductive system were substantial for both [14C] and [125I]. It was concluded that [125I] mono-iodinated nonoxynol-9 and [14C] nonoxynol-9 possessed similar bioavailability.

Administration, Intravaginal↗
PubMed1991

Nonoxynol-9: differential antibacterial activity and enhancement of bacterial adherence to vaginal epithelial cells.

The antibacterial activity and adherence-enhancing effects of nonoxynol-9 were evaluated against vaginal and uropathogenic bacteria. Nonoxynol-9 was markedly less active against the 43 uropathogenic bacterial and yeast strains tested (MIC90, greater than 32%) than against the 26 Gardnerella vaginalis strains (MIC90, less than or equal to 0.015%) and the 53 Lactobacillus strains (MIC90, 8%) tested. Hydrogen peroxide-producing strains of Lactobacillus were more susceptible to nonoxynol-9 (MIC90, 4%) than nonproducers (MIC90, 16%). Two Escherichia coli strains that expressed type 1 fimbriae and three vaginal strains of lactobacilli adhered in significantly higher numbers to vaginal epithelial cells preincubated with 5% nonoxynol-9 than to control cells preincubated with PBS. Spermicides may provide a selective advantage in colonizing the vagina with nonoxynol-9-resistant uropathogens such as E. coli, perhaps via a reduction in vaginal lactobacilli (especially hydrogen peroxide-producing strains) and through enhancement of adherence of E. coli to epithelial cells.

Bacteria↗
PubMedDate not supplied

The spermicide nonoxynol-9 does not inhibit Chlamydia trachomatis in vitro.

The antimicrobial effects of the active ingredient, nonoxynol-9, and the base component of a commercially available spermicide were tested in vitro against Chlamydia trachomatis. The infectivity of cell-free elementary bodies was not affected by nonoxynol-9 or the base after incubation for 30, 60, or 180 min in direct contact with serial twofold dilutions of each agent. The spermicide's effect on the in-vitro growth of C. trachomatis was evaluated after exposure of C. trachomatis-infected McCoy cells to serial dilutions of each agent for 2 hr and for 72 hr. A significant cytopathic effect of nonoxynol-9 on the host cell membrane was observed at concentrations of spermicide between 100% and 0.0014%. However, neither agent was effective in inhibiting the intracellular growth of C. trachomatis at concentrations (0.0014-0.0004%) of nonoxynol-9 that produced no evident cytopathic effect on McCoy cells. Thus, nonoxynol-9 was found to be ineffective in inhibiting infectivity or subsequent growth of C. trachomatis.

Cell Membrane↗
PubMed2005

Why nonoxynol-9 may have failed to prevent acquisition of Neisseria gonorrhoeae in clinical trials.

OBJECTIVES: To understand why clinical trials failed to demonstrate efficacy of nonoxynol-9 in preventing gonorrhea. GOAL: To test the hypothesis that nonoyxnol-9 failed to prevent acquisition of Neisseria gonorrhoeae because most isolates are resistant to killing by nonoyxnol-9 at the level attainable with intravaginal use. STUDY: The lowest concentrations of nonoxynol-9 required to kill or inhibit growth of clinical isolates of N gonorrhoeae and Lactobacillus were determined. RESULTS: Most strains (17 of 25) of N gonorrhoeae (68%) were resistant to the highest concentration of nonoxynol-9 tested (20%). L crispatus (100%), L jensenii (90%), and L iners (79%) were also resistant to nonoxynol-9. CONCLUSIONS: N gonorrhoeae and H2O2-producing strains of vaginal lactobacilli were not killed by nonoxynol-9 at concentrations greater than those achievable in vivo. Earlier studies that formed the basis for subsequent trials most likely did not detect resistance because too few isolates were evaluated. Large numbers of clinical isolates should be examined before the initiation of clinical trial using microbicidal products.

Clinical Trials as Topic↗