Male Latex Condoms Research Articles

Dextrin sulfate vaginal gel: interim data from a phase II study in sexually active healthy women at low risk of HIV infection and their male partners

This is a phase II double-blind placebo-controlled trial to determine the safety (both local and systemic) of a vaginal gel containing 0.125% dextrin sulphate (DS) in healthy sexually active female participants, and a subset of their male partners. The gel is self-administered over two 14 day exposure periods (part 1 and part 2), separated by a 7 day interval. Male latex condoms are used by the partners of all women in part I. In part 2, male partners who wish take part in the study do not use condoms, and are exposed to the gel through sexual intercourse. One application of gel is self-administered vaginally every night. Up to 2 supplementary applications of the gel per day are provided for use prior to sexual intercourse. For all participants, laboratory safety studies and a genital infection screen are performed at each visit. The genital epithelium is examined by colposcopy (females) and naked eye examination (males). To date, 64 women and 7 men have completed the study, which has not yet been unblinded. The study gel has been well tolerated. There has been no disruption of the genital epithelium attributable to gel use and no evidence of systemic absorption of the gel. Minor colposcopic findings, such as erythema and petechiae have been observed frequently.

How well do male latex condoms work? Pregnancy outcome during one menstrual cycle of use

To evaluate the contraceptive effectiveness of male latex condoms, we assembled a cohort of 300 women relying on male latex condoms for contraception and followed them prospectively for one menstrual cycle. None of the 234 women who completed the study and reported at least one act of intercourse conceived (one cycle pregnancy rate 0%; 95% CI 0%–2%). Given the pattern of intercourse during the cycle and 3 different sets of conception probabilities for different days of the cycle, we would have expected between 32 and 36 pregnancies if no condoms had been used. Thus, the prevented fraction due to condom use (effectiveness) is 100% and the lower bounds of the 95% CI are between 89% and 90%. For this cohort, male latex condoms were an effective method of contraception. This cost-efficient approach of evaluating contraceptive effectiveness shows promise for post-marketing studies.

Condom Users Find Baggy Design an Improvement over the Standard Version

This paper summarizes the findings of a randomized crossover study comparing a new loose-fitting male latex condom and a straight shaft condom in terms of rates of breakage and slippage. A total of 102 couples were randomly assigned to use one type of condom and then the other (5 condoms of each type) and were given a questionnaire obtaining detailed information about their experience with each use and a follow-up interview was conducted. Results showed that the baggy condom and the standard straight-shaft condom have similar rates of breakage and slippage. However participants said that the baggy condom which creates more friction for both partners makes sex more enjoyable feels more natural during intercourse is easier to keep on during sex and is not as disruptive during intercourse as the standard version. Since many couples are reluctant to use the standard straight-shaft condoms or do not use them consistently because they reduce pleasure during intercourse the development of a more acceptable version could be a key factor in increasing the use of the method.

Validation of a Corona Discharge Technique to Test Male Latex Condoms for Pinhole Defects

Abstract The Center for Devices and Radiological Health, Food and Drug Administration, evaluated a prototype device using novel technology to detect pinholes in male latex condoms. This device uses multiple electrodes, maintained at high positive voltage, which interrogate a latex condom placed on a conducting mandrel. An electric discharge occurs only when a small hole is present in the condom and is sensed by the device. The mandrel is rotated to map out the entire surface of the condom. Using latex condoms with laser-drilled holes ranging from approximately 1 to 30 µm in diameter, we examined the sensitivity of this device. The smallest holes were detected, and the overall false negative rate was 2%.

Measuring true contraceptive efficacy: A randomized approach—condom vs. spermicide vs. no method

No investigator has attempted to measure prospectively the true efficacy of a contraceptive method, compared with a control group using no method, because contraceptive trials focus on women trying to avoid pregnancy and ethical concerns do not permit the withholding of contraception. We tested the feasibility of an approach that recruited women who desired pregnancy but were willing to postpone conception by 1 month. In this protocol, we restricted frequency and timing of intercourse to one coital act on the most fertile day of the menstrual cycle, as measured by a luteinizing hormone (LH) detection kit. Participants were randomized to use either a male latex condom, spermicidal film, or no method. In this feasibility study we recruited 58 women at three sites, with one site recruiting 25 women in 5 months. Among 54 women who completed the study, we found a 12% pregnancy rate for the group using no method (2/17; 95% confidence interval [CI], 1–36%) and an 11% pregnancy rate for the group using spermicidal film (2/18; 95% CI, 1–35%). No pregnancies occurred among the 19 women using condoms (0/19; 95% CI, 0–18%). The wide confidence intervals illustrate the small sample size of this pilot study and no conclusions can be drawn about the relative efficacy of the methods. Having demonstrated the feasibility of this study design, we now urge the initiation of a large-scale study to evaluate the efficacy of barrier methods using our randomized approach, with a control arm using no method of contraception.