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PubMed1981

Preliminary results, serum chemistry values before and after the intravaginal administration of 5% nonoxynol-9 cream.

Thirty-two healthy premenopausal women between the ages of 18 and 39 were randomly assigned to three study groups as follows: Group I received daily intravaginal administration of 2.5 gm of 5% nonoxynol-9 vaginal cream (Conceptrol [Ortho Pharmaceutical Corporation, Raritan, N. J.] cream) for 14 days. Group II received daily intravaginal administration of 2.5 gm of the cream base alone, and group III received no treatment. The numbers of subjects completing the study were 12, 11, and 7 groups I, II and III, respectively. Fasting blood samples were obtained from each subject prior to treatment and on days 8 and 15 after treatment. Blood samples were analyzed for 20 constituents, including proteins, lipids, triglycerides, and serum enzymes. There were no differences in any of the measured parameters between the pre- and post-treatment periods in any of the groups. On the basis of these findings it may be concluded that there are no apparent systemic effects following daily intravaginal administration of a 125-mg dose of nonoxynol-9 in a cream base for 2 weeks.

Adolescent↗

PubMed1986

Comparison of the action of nonoxynol-9 and chlorhexidine on sperm.

The effect on sperm motility of nonoxynol-9 chlorhexidine diacetate was compared in semen and cervical mucus. Both compounds had similar spermicidal potency in semen, abolishing sperm motility within 3 minutes at 0.5 mg/ml. When these compounds were allowed to diffuse into mucus, the subsequent survival of sperm in the mucus was different. Restricted penetration and loss of motility occurred rapidly after treatment with 0.1 mg/ml chlorhexidine, whereas sperm survived normally in mucus after prolonged contact with 200 mg/ml chlorhexidine. When the compounds were mixed directly with the mucus before sperm penetration was attempted, chlorhexidine still immobilized sperm, but concentrations of nonoxynol-9 that would be spermicidal in semen had no effect in mucus.

Animals↗

PubMed1998

Assessment of a tablet drug delivery system incorporating nonoxynol-9 coprecipitated with polyvinylpyrrolidone in preventing the onset of pregnancy in rabbits.

OBJECTIVE: To assess the in vivo efficacy of the tablet drug delivery system containing nonoxynol-9 coprecipitated with polyvinylpyrrolidone by delivering the spermicidal agents vaginally and evaluating their ability to prevent the onset of pregnancy in rabbits. DESIGN: Controlled clinical study. SETTING: Division of Laboratory and Animal Resources, College of Pharmacy, University of Kentucky. ANIMAL(S): Forty-two New Zealand White female rabbits. INTERVENTION(S): The rabbits were artificially inseminated at various intervals after vaginal insertion of the tablet drug delivery system containing either polyvinylpyrrolidone only (0 minutes) or nonoxynol-9 coprecipitated with polyvinylpyrrolidone (polyvinylpyrrolidone/nonoxynol-9; 0, 3, 30, 180, and 360 minutes). The rabbits were induced to ovulate 6 hours before insemination by i.m. injection of hCG (200 IU). MAIN OUTCOME MEASURE(S): The onset of pregnancy in the rabbits was evaluated after insertion of the tablet drug delivery system containing polyvinylpyrrolidone only or polyvinylpyrrolidone/nonoxynol-9 at various intervals, followed by artificial insemination. RESULT(S): The onset of pregnancy was not reduced significantly when the tablet drug delivery system containing polyvinylpyrrolidone or polyvinylpyrrolidone/nonoxynol-9 was used and insemination was performed immediately after tablet insertion (time 0). However, pregnancy rates (PRs) were reduced significantly in the rabbits that received the tablet drug delivery system containing polyvinylpyrrolidone/nonoxynol-9 and were inseminated at 3, 30, 180, and 360 minutes after tablet insertion. The highest PR reduction occurred between 30 and 180 minutes after insertion of the tablet drug delivery system containing polyvinylpyrrolidone/nonoxynol-9. CONCLUSION(S): The tablet drug delivery system is an efficient method of delivering the tested spermicidal agents vaginally. The design and dosage used in preparing the tablet drug delivery system provide short- and long-term release of the spermicidal agents, which results in almost immediate and extended enhancement of their contraceptive properties.

Administration, Intravaginal↗

PubMed1991

High-performance liquid chromatographic (HPLC) analysis of oligomeric components of the spermicide nonoxynol-9.

The commercially available Nonoxynol-9 spermicide is a multicomponent mixture of oligomers. When Nonoxynol-9 was separated by normal phase gradient HPLC, 17 components were shown to exist in the commercial mixture. These oligomeric components follow a Poisson distribution around the most abundant oligomer, EO 8 (11.7%). Select oligomers were isolated by preparative HPLC (Rt = 19.6, 34.0, 45.6, 51.2, 61.6, and 79.2 min) and purified by HPLC. These were identified by FAB-MS and NMR to be the oligomers EO 3, EO 6, EO 8, EO 9, EO 11, and EO 16, respectively.

Chromatography, High Pressure Liquid↗

PubMed1990

Randomized, double-blind, placebo-controlled, patient-initiated study of topical high- and low-dose interferon-alpha with nonoxynol-9 in the treatment of recurrent genital herpes.

To explore further topical antiviral therapy for recurrent genital herpes, 188 culture-proven patients were randomized to receive treatment with topical interferon-alpha in high-dose (10(6) IU/g with 1% nonoxynol-9 in 3.5% methylcellulose) or low-dose (10(3) IU/g with 0.1% nonoxynol-9 in 3.5% methylcellulose) treatments or placebo (3.5% methylcellulose, alone), applied three times daily for 5 days. Of these, 105 experienced prodromal symptoms within the study period and applied the medication, of whom 99 could be evaluated for efficacy. Patients were followed with daily clinical assessments and cultures until reepithelialization. The median time to negative virus culture in high-dose recipients was 2.5 days compared with 3.9 days for placebo recipients (P = .023), and a significant dose response was observed (P = .016). Antiviral effects were more prominent in men than women. High-dose recipients also had reduced median duration of symptoms to 2.7 days from 3.7 days for placebo recipients (P = .03), with a significant dose-response relationship (P = .047). Effects on duration of symptoms were more prominent in women. Times to complete reepithelialization in those who applied the drug during the prodromal phase were 5.8 days for high-dose recipients compared with 6.5 days for placebo recipients (P = .053). A multivariate ranked linear model analysis of four efficacy variables (crusting, healing, virus shedding, symptom duration) also favored the high-dose gel (P = .015). High-dose topical interferon-alpha preparation is effective for patients with recurrent genital herpes. Applied early in the course of a recurrent episode, this treatment is safe and may provide a topical alternative to other types of therapy in the future.

Administration, Topical↗

PubMed1993

The cat/feline immunodeficiency virus model for transmucosal transmission of AIDS: nonoxynol-9 contraceptive jelly blocks transmission by an infected cell inoculum.

OBJECTIVES: To develop an animal model to study transmucosal lentivirus transmission, and to determine whether topical application of contraceptive jelly can block transmission by an infected cell incoulum. DESIGN: Feline immunodeficiency virus (FIV), a lentivirus similar to HIV, causes an AIDS-like disease in domestic cats. HIV is transmitted primarily across mucosal surfaces, and infected cells may be important in this transmission. We tested the ability of FIV-infected cells to transmit infection across the vaginal, rectal and oral mucosa of the cat, and whether a vaginal contraceptive jelly could prevent such transmission. METHODS: An inoculum consisting of 2 million FIV-infected primary cat T cells was administered vaginally, rectally or orally to female cats that had received either no pretreatment or pretreatment with a contraceptive jelly containing the detergent nonoxynol-9 as spermicide. Transmission was detected by monitoring recipient animals for viral antibodies and by viral cultures of blood leukocytes. RESULTS: A single dose of the infected cell inoculum efficiently transmitted FIV infection when delivered into the vagina or rectum (10 out of 11 animals became infected). Pretreatment of the vagina (five animals) or rectum (four animals) with contraceptive jelly protected all animals from transmission by the highly infectious inoculum. CONCLUSIONS: The cat/FIV model provides an efficient means to study transmucosal transmission of lentivirus infections, and for assessing vaginal barrier methods that could block transmission. One such method, nonoxynol-9 contraceptive jelly, effectively prevents transmucosal transmission by an FIV-infected cell inoculum.

Animals↗

PubMed1992

Correlation between hydrophobicity and resistance to nonoxynol-9 and vancomycin for urogenital isolates of lactobacilli.

Seven clinical isolates of lactobacilli were found to be relatively hydrophobic with a mean water-contact angle of 66 +/- 15 degrees, and to be susceptible to 1% nonoxynol-9 and vancomycin. However, seven other strains were relatively hydrophilic with a mean water-contact angle of 32 +/- 13 degrees, and found to be resistant to 25% nonoxynol-9 and vancomycin. Thus, the surface properties of lactobacilli that influence susceptibility to antimicrobial agents may involve surface hydrophobicity. Possibly the penetration barrier posed by the cell surface towards these two nonionic antimicrobials is lower for hydrophobic cells than for hydrophilic cells.

Adult↗

PubMed1992

The effect of contraceptives containing nonoxynol-9 on the genital transmission of simian immunodeficiency virus in rhesus macaques.

The ability of two nonoxynol-9 spermicide preparations to prevent the genital transmission of SIV in rhesus macaques was compared. Administration of one mL of contraceptive foam before the intravaginal inoculation of cell-free SIV prevented the genital transmission of SIV to three of six animals, and using one mL of contraceptive gel prevented the genital transmission of SIV to two of six animals. Thus, both contraceptive foams and gels containing nonoxynol-9 provided protection against the genital transmission of SIV.

Animals↗

PubMed2004

[Experimental research on tea saponin ameliorating nonoxynol spermicidal action in vitro].

OBJECTIVE: To study the effect of tea saponin in ameliorating nonoxynol(N-9) spermicidal action in vitro. METHODS: According to the improved spermicidal test method in vitro recommended by International Planned Parenthood Foundation (IPPF), we evaluated the minimum spermicidal concentration of N-9, tea saponin and their mixed solution in 20 s and 3 min. RESULTS: The minimum spermicidal concentration of N-9 in the mixed solution was (0.13 +/- 0.05) g/L in 20 s and (0.05 +/- 0.004) g/L in 3 min, and that of the tea saponin in the mixed solution was (2.40 +/- 1.07) g/L in 20 s and (1.27 +/- 0.38) g/L in 3 min, compared with the single ingredient N-9 [(0.48 +/- 0.15) g/L in 20 s, (0.34 +/- 0.079 g/L in 3 min], and tea saponin [(5.78 +/- 1.40) g/L in 20 s, (1.71 +/- 0.176) g/L in 3 min], P < 0.01. CONCLUSION: Tea saponin can improve N-9 spermicidal action in vitro, and tea saponin and nonoxynol have proved of synergic effect.

Animals↗

PubMed2005

Nonoxynol 9 as an additive therapy in metronidazole-resistant cases of vaginal trichomoniasis.

The present study was conducted on 30 female patients with metronidazole resistant vaginal trichomoniasis to investigate the efficacy of nonoxynol 9 (N-9), a non hormonal contraceptive with spermicidal effect, as an additive therapy to metronidazole (MNZ). Study population were randomly divided into 3 groups according to treatment regimen: G.I: patients received high dose MNZ (2 g daily for 7 days) n = 10; G. II: patients received (100 mg N-9 vaginal suppository daily for 7 days) n = 10; G. III: patients receiving conventional MNZ dose (1 g daily for 7 days) plus (a 100 mg N-9 suppository for 7 days) n = 10. Clinical and parasitological evaluation of cure was performed at return visits 1, 2, 4 and 6 weeks post treatment. Negative T. vaginalis vaginal smears were ensured by direct microscopic visualization and In Pouch TV culture technique. Most of the patients were in the 30-39 years age group (60%) and burning was the most frequent symptom (96.67%). The cure rates were 70%, 40% and 90% for Gs I, II & III respectively, while adverse effects of treatment were recorded most frequently by patients of G.I. So, MNZ resistant trichomoniasis incidence seems to be on the rise. Topical therapy alone has a low cure rate while combined oral conventional doses of MNZ and intravaginal nonoxynol 9 treatment appears to be a good clinical trial with fairly good cure rate thus, avoiding the adverse side effects of high doses MNZ therapy and T. vaginalis health hazards potentiality.

Adult↗

PubMed1991

[Observations in vivo on spermicidal effect of nonoxynol-9 contraceptive in forms of effervescent suppository and film].

Spermicidal effect of nonoxynol-9 contraceptive in forms of efferscent suppository and film trade in China were studied in vivo. There were noticeable differences on the spermicidal effect in vivo between the two types and different doses. This study indicated that nonoxynol-9 efferscent suppository was more effective than the np-9 film in spermicidal efficacy. (1) No live sperm was found in the samples of vaginal and cervical mucus in the 20 cases of the suppository group. (2) There were live sperms in the samples of vaginal mucus of 6 cases and cervical mucus of 3 cases among the 20 cases of the film group.

Adult↗

PubMed1991

Resolution of resistant vaginal trichomoniasis associated with the use of intravaginal nonoxynol-9.

An otherwise healthy, sexually inactive woman was determined by in vitro susceptibility testing to have vaginal infection by a strain of Trichomonas vaginalis with high-grade metronidazole resistance. Prolonged high-dose oral and intravaginal metronidazole therapy did not resolve the infection, but caused temporary peripheral neuropathy. Tinidazole was ineffective as well. Serendipitous use of topical intravaginal nonoxynol-9 for contraception appeared to resolve the infection. We reviewed reinfection, noncompliance with therapy, and concomitant use of other drugs that degrade the efficacy of metronidazole as possible causes of falsely "resistant" trichomoniasis. The literature suggests that mebendazole, furazolidone, and anisomycin may be effective for treatment of metronidazole-resistant trichomoniasis. This case and previously published laboratory data suggest that intravaginal nonoxynol-9 deserves further study as a treatment for resistant trichomoniasis, though trichomonal coinfection of the patient's urethra, Skene glands, and sexual partner would not likely be resolved by such therapy.

Adult↗

PubMed1985

In vitro and in vivo evaluation of latex condoms using a two-phase nonoxynol 9 system.

In vitro studies were carried out that indicated that a lubricant system consisting of 0.45 +/- 0.1 ml of silicon fluid containing 6.6% +/- 0.5% by volume of nonoxynol 9 and a spermicidal cream consisting of 0.45 +/- 0.1 ml made up of 63.4% polyethylene glycol 400 and 30.0% polyethylene glycol 3350 containing 6.6% +/- 0.5% nonoxynol 9 was effective in reducing sperm motility and viability. This system was tested in vivo with the use of simulated rupture techniques and was found to be equally as effective. Double-blind preference studies were carried out in vivo which showed that the condom system is convenient and comfortable to use, nonirritating to the vagina or urethral mucosa, and esthetically pleasing to the young, reproductive-age population.

Adult↗

PubMed1996

Comparative spermicidal performance of iodinated and non-iodinated contraceptive formulations of nonoxynol-9 co-precipitated with polyvinylpyrrolidone.

The objective of this study was to evaluate the spermicidal qualities of various combinations of nonoxynol-9 (N-9; whole molecule = oligomers 1-18) and its isolated fractions (oligomers 8-10, 4-6 and 1-3), co-precipitated with non-iodinated and/or iodinated (Io) polyvinylpyrrolidone (PVP) as possible vaginal contraceptives. Spermicidal qualities of known equimolar concentrations of various combinations of PVP/N-9 and PVP-Io/N-9 were tested via a modified Sander-Cramer test (SCT) using human spermatozoa. Spermicidal agents and semen samples were mixed 1:1 (v/v) and evaluated for sperm viability. Spermicidal activity was reported as the minimal concentration (microgram/mL) of spermicide capable of killing all spermatozoa within 20 sec after exposure to the spermicide. The spermicidal activity of PVP/N-9 and PVP-Io/N-9 preparations containing N-9 oligomers 1-18 and/or 8-10 was similar, and these preparations were more efficient in killing the spermatozoa than the ones containing N-9 oligomers 4-6 and 1-3. Polyvinyl-pyrrolidone proved to be an effective vehicle for PVP/N-9 and PVP-Io/N-9 preparations, especially those containing N-9 oligomers 4-6 and 1-3. Incorporation of Io into the spermicidal preparations brought about additional efficacy. The current findings could be of clinical significance in future studies when preparing and delivering those selected co-precipitates vaginally.

Cell Survival↗

PubMed1992

Use of nonoxynol-9 and reduction in rate of gonococcal and chlamydial cervical infections.

The spermicide nonoxynol-9 (N-9) has been used as a contraceptive for over 30 years, but the use of a vaginal spermicide and condoms for the prevention of sexually transmitted infections has not been examined in randomised studies. We report a single-blind randomised field trial to assess the effect of N-9 film on the rate of gonococcal and chlamydial cervical infection in women at high risk of these diseases. 343 women were randomly assigned to use either condoms and N-9 (186 women) or condoms and a placebo (157). Compliance with condom use was much the same in the two groups. Overall, N-9 reduced the rate of cervical infection by 25% (rate ratio [RR] 0.75, 95% confidence interval [Cl] 0.5-1.1); in women who used N-9 for more than 75% of their coital acts the infection rate was reduced by 40% (RR 95% Cl 0.3-1.0). The rate of yeast vulvovaginitis or genital ulcers was not higher in N-9 users than in placebo users, but the rate of symptomatic irritation was increased by 70% (RR 95% Cl 1.1-2.6) among N-9 users. Condom use was more protective against cervical infection than N-9 use. The rate of infection was 50% (RR 95% Cl 0.3-0.7) lower with 75% than with 0-50% condom compliance. The use of a vaginal N-9 spermicide with condoms whenever possible seems to be a better strategy than the use of condoms only for prevention of gonococcal and chlamydial cervical infection.

Administration, Intravaginal↗

PubMed1980

Studies on Nonoxynol-9. II. Intravaginal absorption, distribution, metabolism and excretion in rats and rabbits.

Some pharmacological aspects of Igepal CO-630, used by some pharmaceutical companies as the source of nonylphenoxypoly (ethyleneoxy) ethanol (Nonoxynol-9, N-9) in various spermicidal formulations, were studied. It was found that Igepal CO-630 contains at least 13 components, 70% having molecular weights near that of N-9. After intravaginal administration, the detergent is rapidly and quantitatively absorbed through the vaginal wall into the systemic circulation. The rate of vaginal absorption of N-9 depends on the vehicle in which the detergent is carried. Once in the blood, N-9 is excreted by liver-bile-feces and the kidney-urine routes, the first being more effective in rats, the latter in rabbits. Following intravaginal or intraperitoneal injection of radioactive N-9, the highest content of radioactivity was found in the liver and kidney. The detergent was detected in the milk of lactating rats and the serum of their pups within two hours after the intravaginal dose.

Absorption↗

PubMed1997

Measurement and modulation of nonoxynol-9 diffusion and bioactivity against spermatozoa in human cervical mucus.

Assays of sperm penetration into cervical mucus, in the configuration of double-ended tests (DETs), are an accepted format for evaluating the efficacy of sperm-directed contraceptives in mucus. In order to distinguish relative contributions of compound permeation into, and compound bioactivity within, cervical mucus with respect to vanguard sperm penetration measured in DETs, direct measurements were made of concentration profiles of the spermicide nonoxynol-9 (N9) after diffusion into mucus-filled capillary tubes. N9 was dissolved in two different delivery solutions, deionized water and saline, in an attempt to exploit a Donnan-mediated swelling of mucus for enhanced delivery of the spermicide. Average diffusion coefficients, 7 and 5 x 10(-7) cm2/sec for N9-water and N9-saline, respectively, indicate that the diffusion of N9, a surfactant material, is governed by the size of the N9 micelle rather than the molecular size, in the concentration range typically found in commercial preparations Permeation of N9 into mucus was significantly greater for water versus saline as delivery solution, although the difference was slight. A more pronounced difference between the two treatments was found in DET results, due to an osmotic and/or pH activity of the delivery solution itself against sperm in mucus.

Antispermatogenic Agents↗

PubMed1997

Alteration of human sperm kinematics in cervical mucus due to nonoxynol-9.

Traditional endpoints of the double-ended test (DET), a contraceptive screening assay used to evaluate the ability of a compound to permeate cervical mucus and inhibit sperm progression, ignore important information about sublethal effects upon sperm cells. Improved contraceptive agents may capitalize on such sublethal aspects. This study utilized a DET testing protocol that included measurement of human sperm motion characteristics as an indicator of cell function within spermicide-exposed human mucus. The currently available spermicide nonoxynol-9 (N9) was used as the test compound and was dissolved in two different delivery solutions, deionized (DI) water and saline, to evaluate the effects of the osmolarity and pH of the delivery vehicle on test results. The N9-water treatment demonstrated significantly greater activity than the N9-saline treatment in terms of all measured variables, exhibiting an apparent "biopermeation" distance approximately 3 mm further into the mucus. The DI water control treatment displayed less activity than N9-saline in terms of the vanguard penetration distance, but comparable or greater activity in terms of inhibiting kinematic variables. The saline control treatment had no effect in terms of any measured variable. Dose responses to N9 of sperm in mucus were inferred from DET results combined with direct measures of N9 diffusion. These were compared to dose responses to N9 of seminal sperm, indicating that N9 inhibits sperm motion at lower concentrations in mucus than in semen.

Cervix Mucus↗