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At least 19 recordsLinked to original sources
PubMed1995

[Damage to condoms caused by vaginally administered drug].

A 28-year-old woman who was treated for vaginal candidiasis with Gyno-Daktarin vaginal capsules (miconazole nitrate) became pregnant because a condom used during intercourse had ruptured. Incubation in vitro with 400 and 1200 mg miconazole nitrate vaginal capsules (Gyno-Daktarin 3 and Gyno-Daktarin I), but not miconazole nitrate vaginal cream (20 mg/g), was shown to damage rubber condoms. Patients using vaginal medicines should be aware of a possible adverse effect on rubber condoms or contraceptive diaphragms and a subsequent increased risk of pregnancy or contagious diseases such as AIDS. Fatty excipients such as glycerin, paraffin, petrolatum or Witepsol may be involved.

Administration, Intravaginal↗
PubMed1989

Guidelines and requirements for the evaluation of contraceptive steroids.

Since their introduction in the early 1960s, the oral contraceptive (OCs) steroids have been subjected to preclinical and clinical investigations unprecedented in medical history. As a result of such extensive studies, it is now possible to make a comprehensive review of preclinical and clinical data on oral contraceptives. The OCs were introduced at a time when the Food and Drug Administration (FDA) was undergoing drastic changes as a result of the thalidomide tragedy, the introduction of the Kefauver-Harris Amendment, and the desire for greater control over the pharmaceutical industry. The initial requirements for the safety evaluation of OCs were identical to those of other drugs. There were no explicit requirements for OCs although it was generally felt that the requirements should be more stringent because the OCs were being used in otherwise healthy women for long periods of time and with minimal medical supervision. In the 1960s when it became apparent from ongoing studies that there was an increased incidence of mammary tumors in dogs treated with some progestins, the FDA made the decision to terminate clinical studies and established the requirement for 7- and 10-yr studies in dogs and monkeys, respectively. The primary purpose of this paper is to present an historical perspective of the evolution of the preclinical requirements for the evaluation of the safety of OCs prior to their use in the various phases (I, II, III) of clinical trials. Some proposed changes in the requirements are discussed. This information will form the basis for other presentations dealing with the safety assessment of OCs in rats, dogs, and monkeys.

Animals↗
PubMed1991

Interchangeability of low-dose oral contraceptives. Are current bioequivalent testing measures adequate to ensure therapeutic equivalency?

Current Food and Drug Administration guidelines for assessing the differences in bioavailability between generic oral contraceptives and brand-name products are inadequate to ensure therapeutic equivalence. The guidelines do not take into account those women who may have blood levels of active ingredients well outside the range of acceptability. Due to the narrow therapeutic range of steroids, these women may become pregnant or experience an increased incidence of breakthrough bleeding. Furthermore, oral contraceptive packaging is unique to each manufacturer, and any change in brands (and therefore packaging) can easily negate the sequential administration of the appropriate tablet. These are among the reasons proposed for placing oral contraceptives in the critical drug category, in which generic substitution and interchangeability of products should not be allowed.

Biological Availability↗
PubMed1989

Latex condom deterioration accelerated by environmental factors: I. Ozone.

Commercial non-lubricated latex condoms were unpackaged and exposed in an environmental chamber to ozone levels (0.3 ppm) commonly present in urban smog conditions. Deterioration was observed by scanning electron microscopy after 18 hours exposure. Loss of mechanical strength was quantitated by measurement of the air pressures necessary to burst the condom and volumes at burst. After 24 hours exposure to ozone the latex surface was covered with craters and after 48 hours the pressure required to burst the condom was 44% that of control samples. Data suggest the need for study of the effectiveness of lubrication and packaging in protecting condoms from environmental factors which may accelerate deterioration.

Contraceptive Devices, Male↗
PubMed1993

Efficacy of thermoplastic elastomer and latex condoms as viral barriers.

The barrier efficacy of a thermoplastic elastomer (TPE) and three brands of latex condoms was compared in a passive-leak test and in a dynamic model of simulated intercourse. Fifteen replicates of each of the condoms were challenged with bacteriophage T7 (100 nm) and the polio virus Type 1 (PV-1, 27 nm). In the passive test, no condom leaked either virus. In the dynamic model, no TPE condoms leaked either virus and no latex condoms leaked T7. Two samples of one commercially available latex condom leaked T7 but not PV-1. These data support that intact latex condoms are effective in vivo viral barriers and extend the finding to TPE condoms as well. Given its substantial equivalence to latex as a viral barrier, TPE condoms are an alternative choice for individuals with latex allergies. The TPE material is also more resistant to common environmental conditions that affect latex adversely and should therefore be a superior choice if condoms must be stored for extended periods in suboptimal conditions.

Bacteriophage T7↗
PubMed1997

An actual use comparison of condoms meeting Australian and Swiss standards: results of a double-blind crossover trial.

The performance of condoms in actual use has been poorly researched in the past, especially in comparing condoms that met different quality control standards as indicated by laboratory testing. The present study used a double-blind crossover design to compare the performance of 2 types of condoms in actual use; one that met the Australian and International Organization for Standardization (ISO) standards for condom quality and one that met the more stringent Swiss Quality Seal requirements. Ninety-two men recruited from Metropolitan Melbourne completed a self-report diary sheet after each condom was used which assessed the performance of the condom and the conditions under which it was used. From a total of 1917 condom uses, there was an overall breakage risk of 2.7%. The breakage risk ratio (Australian/ISO:Swiss) for all types of use was 1.16 (95% confidence interval 0.68-1.99). When subanalyses by method of entry were performed, the condoms meeting the Swiss standard appeared to fare better than the Australian/ ISO standards for anal sex (RR = 4.84, 95% CI 1.07-21.8, P = 0.022), while the opposite was the case for vaginal sex (RR = 0.74, 95% CI 0.35-1.53, P = 0.41). The result for anal use was statistically significant at the 5% level, despite being based on fewer condom trials than that for vaginal use, but this result needs to be replicated. Although the participants appeared representative of the general male population in Melbourne in the age bracket 18-46 years, there was a significant history of condom usage reported. This may have influenced the risk of breakage.

Adult↗
PubMed1984

Nursing protocol for diaphragm contraception.

The diaphragm is becoming the more popular method of birth control in the United States. When used properly, it is a safe and effective alternative for those women who are unable to take birth control pills or prefer another method. The protocol presented here is a comprehensive approach to diaphragm fitting, client instruction and follow-up. The practitioner utilizing such an approach will insure a safe and highly effective method of birth control to those patients who choose the diaphragm as their method of contraception.

Contraceptive Devices, Female↗
PubMedDate not supplied

Effectiveness of latex condoms as a barrier to human immunodeficiency virus-sized particles under conditions of simulated use.

Condoms were tested in an in vitro system simulating key physical conditions that can influence viral particle leakage through condoms during actual coitus. The system quantitatively addresses pressure, pH, temperature, surfactant properties, and anatomical geometry. A suspension of fluorescence-labeled, 110-nm polystyrene microspheres models free human immunodeficiency virus (HIV) in semen, and condom leakage is detected spectrofluorometrically. Leakage of HIV-sized particles through latex condoms was detectable (P less than 0.03) for as many as 29 of the 89 condoms tested. Worst-case condom barrier effectiveness (fluid transfer prevention), however, is shown to be at least 10(4) times better than not using a condom at all, suggesting that condom use substantially reduces but does not eliminate the risk of HIV transmission.

Contraceptive Devices, Male↗