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At least 19 recordsLinked to original sources
PubMed1981

Vaginal spermicides and congenital disorders.

Among 763 liveborn infants of white women who had obtained a vaginal spermicide in the ten months before conception, the prevalence of certain major congenital anomalies was 2.2%. The prevalence of such anomalies in a comparison group of 3,902 infants was 1.0%. The difference between these groups was due to an excess of limb-reduction deformities, neoplasms, syndromes associated with chromosomal abnormalities, and hypospadias in the infants whose mothers are presumed to have used vaginal spermicides. Pregnancies in women who had used vaginal spermicides ended in spontaneous abortion requiring hospitalization 1.8 times more commonly than did pregnancies in those who had not. Since a well-defined syndrome among babies with congenital disorders whose mothers used spermicides was not present, these results should be considered tentative until confirmed by other data.

Abnormalities, Drug-Induced↗
PubMed1981

Postcoital, Vaginal, spermicidal potency of formulations: the Macaca arctoides (stumptailed macaque) as animal model.

The Macaca arctoides (stumptailed macaque) was found to be a good animal model for determining the postcoital spermicidal activity of vaginal preparations. The stumptailed macaque is easy to handle, so formulations can be inserted correctly into the vagina just before coitus. The male mates rapidly, and the entire test can be completed within 5 to 10 minutes, minimizing all extraneous factors other than those inherent to the reproductive tract and the coital act. Data from postcoital breeding experiments were found to be reliable and consistent when results of six primate mating tests for a single dose level of a test formulation were averaged. Dose-response curves can be prepared from these average results, and the relative in vivo effectiveness of the spermicides can be determined. The Sander-Cramer test proved to be a good assay with which to quantitate the in vitro spermicidal potency of formulations. The spermicidal preparations tested immobilized human and primate spermatozoa in vitro to the same extent with the exception of one formulation (possibly due to the vehicle in which the active ingredient was incorporated). The relative spermicidal effectiveness of preparations differs with in vitro and postcoital testing. Because the latter is a more realistic indicator of the contraceptive potency of a formulation, it is recommended that postcoital primate experiments be performed with newly developed vaginal spermicides before extensive animal breeding experiments clinical trials are initiated.

Animals↗
PubMed1990

Comparative vaginal spermicidal studies in the stumptailed macaque with alkyloxynol-741, nonoxynol-9 and chlorhexidine.

Alkyloxynol-741 ("agent 741") is used in the People's Republic of China as a substitute for nonoxynol-9 in vaginal contraceptive formulations. However, no studies are available that compare the effectiveness of these agents as vaginal spermicides. For this reason, dissolvable polyvinylalcohol (PVA) films were prepared containing various concentrations of alkyloxynol-741 and nonoxynol-9. Films were also prepared containing chlorhexidine, a potentially new vaginal contraceptive agent. Postcoital vaginal spermicidal studies were performed with the films in the stumptailed macaque (Macaca arctoides). The order of spermicidal potency was: alkyloxynol-741 greater than nonoxynol-9 greater than chlorhexidine. These observations suggest that alkyloxynol-741 can be used instead of nonoxynol-9 in those countries where alkyloxynol-741 is more readily available and can be obtained at a lower cost.

Animals↗
PubMed1982

Vaginal spermicides and gonorrhea.

All positive cultures for neisseria gonorrhoeae recorded from Dec 20, 1978, through Dec 31, 1980, for women born between 1940 and 1960 were identified among members of Group Health Cooperative of Puget Sound, Seattle, and rates of gonorrhea were calculated for recent oral contraceptive users, recent vaginal spermicide users, and women with surgical sterilization. The risk ratio (RR) estimate, based on the included population, for spermicide users compared with all others was 0.23 (90% confidence interval [Cl], 0.10, 0.50). When women with positive cultures for N gonorrhoeae were compared with women with negative cultures, the RR estimate comparing spermicide users with all others was 0.13 (90% Cl, 0.05, 0.34). The results are consistent with the protective effect of vaginal spermicides against gonorrhea.

Adult↗
PubMed1982

Vaginal spermicides and miscarriage seen primarily in the emergency room.

Among 813 women who had obtained a vaginal spermicide within 48 weeks of the estimated date of fertilization (EDF), 47 (5.8%) had an early miscarriage. Among women who had obtained oral contraceptives, 35/1,127 (3.1%) miscarried, and among women who obtained neither, 140/4,231 (3.3%) miscarried. The risk ratio estimate comparing spermicide users with nonusers was 1.8 (90% confidence interval 1.4, 2.3). The association was strongest among women who had obtained a spermicide within 12 weeks of the EDF. Examination of abortus material revealed that the association with spermicides was strongest among those where an abnormal fetus was present.

Abnormalities, Drug-Induced↗
PubMed2001

Contraceptive efficacy and safety studies of a novel microemulsion-based lipophilic vaginal spermicide.

OBJECTIVE: To investigate the in vivo contraceptive potency and safety of a novel microemulsion-based lipophilic vaginal spermicide. DESIGN: In vitro and in vivo spermicidal activity and safety of a submicron-particle-size, lipophilic gel-microemulsion (GM-4). SETTING: Center for Advanced Preclinical Sciences at the Parker Hughes Institute. PATIENT(S): Nine male volunteer sperm donors. INTERVENTION(S): Motile human sperm in semen and medium were exposed to eight GM-4 components or GM-4 formulation. Forty-eight ovulated NZW rabbits in subgroups of 16 with or without intravaginal administration of GM-4 or nonoxynol-9 gel (N-9; Gynol II) were artificially inseminated and allowed to complete pregnancy. Eleven rabbits were exposed to daily intravaginal application of GM-4 with and without N-9 for 10 consecutive days. Ten of 20 B(6)C(3)F(1) mice were given repetitive intravaginal application of GM-4 for 5 days/week over 13 consecutive weeks. MAIN OUTCOME MEASURE(S): The motility of human sperm treated with GM-4 components and GM-4. Term pregnancy in rabbits and histopathological grading of rabbit vaginal tissue for irritation. Evaluation of mice for survival, growth, hematologic parameters, blood-chemistry profiles, absolute and relative organ weights, and histopathology. RESULT(S): The individual components of GM-4 lacked spermicidal activity in human semen, whereas the GM-4 formulation containing all the eight pharmacological excipients exhibited potent spermicidal activity with rapid kinetics. GM-4 showed remarkable contraceptive activity in the rigorous rabbit model. None of the 16 (0%) rabbits given GM-4 intravaginally before artificial insemination became pregnant. By contrast, 15 of 16 (93.7%) control rabbits and 5 of 16 (31.2%) Gynol II-treated rabbits became pregnant and delivered newborns. Thus, GM-4 was a significantly more effective contraceptive than a commercially available N-9 gel [100% vs. 68.7% protection; P< 0.05, Fisher's exact test]. Unlike the rabbits treated with N-9, none of the rabbits that were given GM-4 intravaginally for 10 consecutive days developed epithelial ulceration, edema, leukocyte influx, or vascular congestion characteristic of inflammation. Furthermore, repeated intravaginal application of GM-4 for up to 13 weeks in mice had no adverse effects on survival, growth, metabolism, or organ function. CONCLUSION: We conclude that the novel spermicidal GM-4 formulation is safe and significantly more effective than N-9 in preventing conception.

Animals↗
PubMedDate not supplied

Vaginal spermicides, chromosomal abnormalities and limb reduction defects.

Each year, 300,000-600,000 U.S. women become pregnant while using vaginal spermicides. Two recent reports hypothesized that offspring from these pregnancies are at increased risk of certain birth defects, particularly limb reduction defects and such chromosomal abnormalities as Down syndrome. In a case-control analysis of data from the Metropolitan Atlanta Congenital Defects Program (MACDP), we studied the teratogenicity of spermicides by comparing their use around the time of conception by mothers of infants with chromosomal abnormalities and limb reduction defects to their use by mothers of infants with birth defects that have not been linked to spermicides. The results do not support the hypothesis that spermicides are teratogenic. For infants whose mothers used spermicides at the time of conception, the relative risk of having Down syndrome was 1.2 and that for other chromosomal abnormalities was also 1.2. The relative risk of limb reduction defects among infants exposed to spermicides in the first trimester was 1.0. None of these risks is statistically significant.

Chromosome Aberrations↗
PubMed2001

Gel-microemulsions as vaginal spermicides and intravaginal drug delivery vehicles.

There is a need for novel formulations to improve the bioavailability through the vaginal/rectal mucosa of microbicidal drug substances against sexually transmitted diseases. In addition, there is a need for more effective and less toxic vaginal spermicides. Here we review our recent discovery of novel gel-microemulsions (GM) as nontoxic, dual-function intravaginal spermicides, which can be used as delivery vehicles for lipophilic drug substances targeting sexually transmitted pathogens. We describe the formulation and biologic properties of 2 novel, submicron-particle-size GMs, GM-4 and GM-144, which were prepared from commonly available pharmaceutical excipients. These GMs comprising oil-in-water microemulsion and polymeric hydrogels were designed to solubilize lipophilic antiviral/antimicrobial agents and exhibited rapid spermicidal activity in human semen. Preclinical studies comparing the in vivo contraceptive efficacy of GM-4 and GM-144 versus nonoxynol-9-based detergent spermicide (Gynol II) in the rigorous rabbit model confirmed the potent contraceptive activity of these GMs. Unlike nonoxynol-9, repeated intravaginal applications of GM-4 and GM-144 in the rabbit vaginal irritation test were not associated with local inflammation or damage of the vaginal mucosa or epithelium. Furthermore, in short-term toxicity studies performed in mice, repetitive intravaginal application of spermicidal GM-4 and GM-144 for up to 13 weeks was not associated with any local, systemic, or reproductive toxicity. Spermicidal GMs have unprecedented potential as dual function microbicidal contraceptives to improve vaginal bioavailability of poorly soluble antimicrobial agents without causing significant vaginal damage.

Administration, Intravaginal↗
PubMed1982

Vaginal spermicides and outcome of pregnancy: findings in a large cohort study.

By the end of 1980, 5729 singleton planned pregnancies, 1552 singleton unplanned pregnancies, and 81 multiple pregnancies had been observed among the 17032 participants in the Oxford-Family Planning Association contraceptive study. The outcome of these pregnancies was investigated in relation to the use of vaginal spermicides. There was some suggestion that spermicide use might have a small adverse effect on the risk of congenital malformations, especially among infants conceived as a result of contraceptive failure. There was not, however, any evidence of any other adverse effect of spermicide use. In particular, the results provide strong evidence against the hypothesis that spermicide use has any appreciable effect on the risk of spontaneous abortion.

Abnormalities, Drug-Induced↗
PubMed1983

An user acceptability study of vaginal spermicides in combination with barrier methods or an IUCD.

Ninety-eight women were entered into an open study of Staycept jelly (octoxynol 1% w/w) and Staycept pessaries (vaginal suppositories) (nonoxynol-9 6% w/w) in combination with other vaginal methods of contraception. Medical problems during use of either pessary or jelly were few and were restricted to genital irritation or increased vaginal discharge. This seemed more common with the pessaries than with the jelly, but this could have been related to the types of women entered. There were no unplanned pregnancies.

Contraceptive Devices, Female↗
PubMed1995

Frequent use of menfegol spermicidal vaginal foaming tablets associated with a high incidence of genital lesions.

Menfegol is a spermicide with in vitro activity against human immunodeficiency virus (HIV). A randomized placebo-controlled safety study covered the use of menfegol foaming tablets for 14 days at increasing frequencies of insertion by 125 prostitutes in Dakar, Senegal. The frequencies of colposcopically diagnosed genital lesions were 5.0%, 11.8%, 27.8%, 49.7%, and 29.4% among menfegol recipients when tablets were used once every other day or 1, 2, 4, or 8 times a day, respectively (P < .05). Among placebo recipients, frequencies were 11.1% and 23.5% when tablets were used < 8 times daily and 8 times daily, respectively. There was no association between subjective genital symptoms and the incidence of colposcopically detected lesions. The high incidence of genital lesions when menfegol foaming tablets were used more than once daily suggests that their frequent use should not be recommended to prevent HIV transmission. In use at low frequency, the tablets' toxicity might be balanced by anti-HIV properties. Safety studies on vaginal microbicides should use objective methods, such as colposcopy, to assess the incidence of lesions.

Adult↗
PubMed1986

Vaginal spermicides and spontaneous abortion of known karyotype.

The relationship between spermicide use and spontaneous abortion was examined in a New York City case-control study carried out during 1974-1982. In a series of matched sample analyses, case groups categorized by karyotype of the abortus were compared to a control group of prenatal patients with respect to spermicide use. Spermicide use was defined in terms of proximity to the date of conception of the study pregnancy and duration of the episode of use most recent to the study pregnancy. There was no association between spermicide use defined either in terms of recency or duration of use and chromosomally normal abortions, which comprise about 60% of all spontaneous abortions. Similarly, there was no association between spermicide use and the various types of chromosomally abnormal abortions, with the exception of trisomic abortion. Spermicide use for more than one year at any time prior to conception was more common in the cases aborting trisomic conceptions than in the control group (odds ratio = 1.9, confidence limits = 1.2, 3.0). There was evidence to suggest that the association varied with maternal age and phase of entrance into the study.

Abortion, Spontaneous↗