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NIH-FUNDED DISPOSABLE DIAPHRAGM WITH CONTROLLED-RELEASE SPERMICIDE

Executive Summary

NIH-FUNDED DISPOSABLE DIAPHRAGM WITH CONTROLLED-RELEASE SPERMICIDE currently is awaiting investigational new drug (IND) approval for a Phase I clinical trial from FDA's Division of Metabolic & Endocrine Products, an NIH spokesman said. The Natl. Institute of Child Health & Human Development's Center for Population Research Contraceptive Development Branch is fully funding the research and development of the device, conducted at the Southern Research Institute in Birmingham, Alabama, the spokesman said. Begun in October 1980, NIH thus far has provided $762,872 for the project. Southern Research Institute, a nonprofit center, is "actively pursuing" commercial sponsorship for the device, the NIH spokesman said. The disposable diaphragm is made of synthetic elastomer with a non-metal reinforcement, the spokesman said, noting that its stability upon placement "comes from the elastomer itself." In addition to having a cross-section diameter proportionally "a little larger" than comparable-sized diaphragms made of latex or silicone, the elastomer diaphragm is stronger than diaphragms made of those materials, he said. The nonoxynol-9 spermicide, premixed in the elastomer material by the mfr. during production, diffuses out of the diaphragm "in a controlled fashion" after insertion, the spokesman said. The diaphragm can be worn and is effective for up to 24 hours, researchers currently estimate. The time-release feature eliminates the need for additional applications of spermicide if intercourse is repeated, the NIH official said. The Southern Research Institute team, headed by Richard Dunn, PhD, conducted toxicology studies with the device in rabbits, and efficacy and local irritation studies with baboons. No adverse effects have been observed thus far, the NIH spokesman said. A clinical study of 10 to 12 women, scheduled for later this spring, will test for local irritation and levels of acceptability over progressively longer intervals up to 24 hours. Postcoital efficacy studies also will be performed "at a couple of timed intervals," the spokesman said. As currently designed, the diaphragm would be fitted by a physician and then purchased via a refillable prescription, he explained. The possibility of developing a "one-size-fits-all" over the counter diaphragm will be explored in the Phase II study, he said. The NIH Center for Population Research also has awarded a contract to Biotek, a Woburn, Massachusetts company, to develop a controlled-release contraceptive suppository. Biotek has developed a capsule which, after an initial "burst" of spermicide, will release the spermicide continuously over a 16-hour period, the NIH spokesman said. Animal tests with the suppository have been completed, and the company currently is preparing an IND for Phase I clinical trials, he added. NIH has awarded Biotek $440,898 since October 1981, for its contraceptive suppository research.

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