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New condoms for men and women, diaphragms, cervical caps, and spermicides: overcoming barriers to barriers and spermicides.

Barriers and spermicides are being developed for the prevention of unwanted pregnancy and sexually transmitted infection. The inconvenience of current methods limits their acceptability and leads to higher user failure rates. New methods, such as female condoms, nonlatex male condoms, and new cervical caps are being developed: the Reality (Wisconsin Pharmacal, Jackson, WI) polyurethane vaginal pouch has already received conditional Food and Drug Administration approval for use in the United States. The material used in a Food and Drug Administration-approved nonallergenic glove is being tested for its effectiveness as a condom. In addition, the Fem Cap, a cervical cap that had a life table probability of failure within 1 year of 4.8%, is expected to be available within the next 2 years. It is important for clinicians to be informed of new options becoming available for those patients who may be good candidates for these barrier methods.

Contraceptive Devices↗

Vaginal colonization of Escherichia coli and its relation to contraceptive methods.

The prevalence rate of vaginal colonization with E. coli was studied prospectively among 495 healthy premenopausal women, and factors associated with vaginal carriage of E. coli were examined. Vaginal colonization with E. coli was found in 12% of women, and was significantly correlated with phase of the menstrual cycle (p less than 0.05), prior use of antibiotics (p less than 0.05), current genital complaints (p less than 0.05), history of previous urinary tract infection (p less than 0.001), and use of diaphragm or cervical cap for contraception (p less than 0.005). The high prevalence rate among diaphragm or cervical cap users remained significant when other confounding factors were kept constant (p less than 0.05). This observation may explain the association of diaphragm use and urinary tract infection demonstrated in previous epidemiologic studies and confirmed in the present study (p less than 0.05).

Adult↗

Development of the polyurethane sponge as a delivery system for aryl 4-guanidinobenzoates.

The Today Contraceptive Sponge was evaluated as a vehicle for the delivery of aryl 4-guanidinobenzoates (AGs) which are highly active sperm acrosin inhibitors. Studies in animals have shown that several AGs are more potent vaginal contraceptives and less irritating to the vagina than nonoxynol-9 (N-9), the most frequently used active ingredient in commercial vaginal contraceptive formulations. Neither nonoxynol-9 nor the material that could be solubilized from the sponge matrix altered the enzyme-inhibitory activity of 4'-acetamidophenyl 4-guanidinobenzoate HCl (AGB), 4'-carboxyphenyl 4-guanidinobenzoate HCl (EGB) or 4'-carbomethoxyphenyl 4-guanidinobenzoate HCl (MSGB). Besides being acrosin inhibitors, all three AGs exhibited antimotility activity towards human spermatozoa, EGB being as potent as N-9. The antimotility effects of the AGs and N-9 were additive. For subsequent studies, AGB was used as the model compound. Manufacture of the AGB-containing sponges did not affect the chemical structure of AGB. Good release rates of AGB were obtained from the sponges over a 7-day period. The release rates were 20-50% higher when the sponges also contained N-9. These results indicate that certain AGs exert a dual contraceptive action on spermatozoa by inhibiting both the sperm enzyme acrosin and sperm motility. Furthermore, the polyurethane sponge appears to be a convenient and satisfactory long-term delivery system for the AGs. A mixture of N-9 and AG can be used clinically because these compounds have no adverse effects on each other.

Benzoates↗

Diaphragm insertion increases human vaginal oxygen tension.

The normal insertion of a contraceptive diaphragm into the vagina of five young women induced a dramatic increase in the vaginal oxygen tension (131 +/- 13 mm Hg, mean +/- SD, n = 5), which slowly fell at an initial rate of 0.9 +/- 0.2 mm Hg/min. Withdrawal of the diaphragm immediately restored vaginal oxygen tension to the normal hypoxic state (11 +/- 12 mm Hg). The change in gaseous equilibrium created by the trapped air of the diaphragm could have significant actions on the microbial activity and balance of the vagina.

Adult↗

A phase I study of Femcap used with and without spermicide. Postcoital testing.

The objectives of the study were to assess the ability of the Femcap, a new vaginal contraceptive device made of silicone and designed to fit snugly around the cervix to prevent the penetration of sperm into midcycle cervical mucus when used with and without spermicide; and to compare it with the standard contraceptive diaphragm used with spermicide. Eight women underwent two baseline cycles of postcoital testing in which no device was used, followed by three test cycles in which Femcap with spermicide, Femcap with nonspermicidal lubricant (K'Y gel) or the Ortho All-Flex diaphragm with spermicide was used. The sequence of testing cycles was randomized. In each cycle, condoms were used prior to midcycle, then a midcycle cervical mucus specimen was examined to ensure midcycle characteristics and the absence of sperm. Each woman then had intercourse using either no device (baseline cycles) or the prescribed device (test cycles) and returned 2-3 h afterwards. Cervical mucus was again assessed for adequacy and the presence of spermatozoa. The average number of progressively motile sperm seen per high power field was as follows: first baseline cycle, 18.0; second baseline cycle, 17.8; test cycle with Femcap used with nonspermicidal lubricant, 0.1; test cycle with Femcap used with spermicide, 0.2; and test cycle with the diaphragm used with spermicide, 0.0. There was no significant difference between baseline cycles or among test cycles in the average number of progressively motile sperm seen (p > 0.05). The average number of progressively motile sperm seen in each test cycle did, however, differ significantly from the average number seen in either baseline cycle (p < 0.05). Femcap, used with either a spermicidal lubricant or a nonspermicidal lubricant, appears to be comparable with the diaphragm used with spermicide in preventing sperm from entering midcycle cervical mucus.

Cervix Mucus↗

Contraceptive and reproductive risks for cervical dysplasia in southwestern Hispanic and non-Hispanic white women.

BACKGROUND: Various contraceptive practices and reproductive factors have been associated with cervical neoplasia in case-control studies worldwide. METHODS: To investigate contraceptive and reproductive risk factors associated with high-grade cervical dysplasia in southwestern Hispanic and non-Hispanic white women, we carried out a clinic-based case-control study among university-affiliated clinic attendees. RESULTS: Oral contraceptive use ever (odds ratio [OR] = 0.4, 95% confidence interval [CI]: 0.2-0.9) and past diaphragm use (OR = 0.3, 95% CI: 0.1-0.8) were protective for dysplasia in analyses adjusted for age, ethnicity, sexual behaviour, and for cervical papillomavirus (HPV) infection. After further adjustment for Pap smear screening interval, oral contraceptive use ever remained protective for dysplasia. Vaginal deliveries were strongly associated with dysplasia with > 2 vaginal deliveries associated with a 3.9-fold increase in risk after adjustment for age, ethnicity, sexual behaviour, and HPV infection. Using logistic regression models to simultaneously control for effects of multiple factors as potentially related to cervical dysplasia, we found low educational attainment, cervical HPV infection, cigarette smoking, history of any sexually transmitted disease, and having one or more vaginal deliveries to be associated with dysplasia; oral contraceptive use and past diaphragm use also remained protective for high-grade cervical dysplasia in these regression analyses. CONCLUSIONS: The data suggest that use of oral contraceptives (ever) and past diaphragm use are protective for high-grade cervical dysplasia among Hispanic and non-Hispanic white women in New Mexico. The clinic-based perspective of this research (versus population-based studies) may help explain some of these findings.

Case-Control Studies↗

Cervical dilatation by Lamicel--studies on the mechanism of action.

Lamicel is a synthetic hydrophilic polymer tent which produces cervical softening and dilatation when inserted into the endocervical canal. To investigate the mechanism of action of Lamicel, the intrauterine pressure and levels of 6-keto-prostaglandin F1 alpha, 13-14-dihydro-15-keto-prostaglandin F2 alpha, oestradiol and progesterone in plasma and amniotic fluid were measured in patients undergoing second trimester abortion. There was no significant change in any of the measured hormones during a 2-h treatment with Lamicel, but uterine activity increased significantly for 10 min after insertion, then settled spontaneously to below pre-treatment levels. Peripheral plasma levels of magnesium sulphate measured in patients undergoing first trimester abortion were not significantly raised after insertion of Lamicel. Light microscopic examination of cervical specimens, obtained at hysterectomy from patients pre-treated with Lamicel for 24 h, revealed minimum increase in vascularity, mast cell population and ground substance mucopolysaccharides.

6-Ketoprostaglandin F1 alpha↗

Choosing condoms.

Condoms for men are currently the most effective of the nonprescription contraceptive methods. They are readily available, simple to use, and relatively inexpensive, and they are not associated with major adverse effects. If used both properly and consistently, condoms can significantly reduce the risk of transmission of HIV and other STDs. The protection offered by the latex condom may be increased by the concurrent use of a vaginal foam or cream containing nonoxynol 9. The practicing pharmacist should know about the variety of condoms available, be able to explain their correct use to maximize effectiveness, and compare condom use with other types of contraceptives. The practitioner should be available to answer patrons' questions and provide counseling on contraceptives and "safe sex" practices.

Choice Behavior↗