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  1. 1

    Design and conduct of clinical trials of contraceptive methods [letter]

    Farley TM


    Comments on the topic of selection of subjects for clinical trials of contraceptives, in response to a review on design of clinical trials, point out the inadvisability of restricting the study population to women of known high fertility. First, limiting the study group may make recruitment difficult. More important, however, most contraceptive trials look at other end point besides pregnancy: data are collected on use effectiveness, patient satisfaction and continuation rates. This information is best obtained from women representative of the whole community, such as those close to 45 years old. If a study group representative of the total population is used, results can be applied to field conditions with confidence.
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  2. 2

    Long acting steroid formulations.

    Rudel HW; Kincl FA

    In: Diczfalusy, E. and Borel, U., eds. Control of human fertility. Proceedings of the Fifteenth Nobel Symposium, Sodergarn, Lidingo, Sweden, May 27-29, 1970. New York, Wiley, 1971. 39-51.

    A drug delivery system providing for a controlled release of progestogen and affecting ovulation and steroidogenesis minimally would deal effectively with some of the problems associated with contraception. 2 systems being developed which fit these criteria are the primary topics of discourse in this article. In 1 system an implant consists of a polymer membrane of polydimethylsiloxane (PDS) and contains the progestogen in crystalline form. Major problems with the PDS implants include a lack of intraindividual constance of release and interindividual variation in the slope of the decay in release. In the second system the implant consists of a lipid-steroid membrane containing a steroid. In this implant the concentration of the steroid in the membrane and the nature of the lipid phase may be important in determining the pattern of release. In vivo metabolic studies with lipid-steroid pellets are limited, but the patterns of output may be similar to those seen with PDS implants. Because of rate problems, a shorter regime slow-release implant seems more feasible than a longer lasting system. Surgical difficulties associated with the implantation and removal of the PDS implant make the choice of a lipid-steroid micropellet preparation more feasible for a short-term regimen. The discussion, following the main body of the article, focuses primarily on problems associated with implants.
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