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  • Title: Alternate delivery systems for contraceptive progestogens.
    Author: Ginsburg KA, Moghissi KS.
    Journal: Fertil Steril; 1988 May; 49(5 Suppl 2):16S-30S. PubMed ID: 3282932.
    Abstract:
    Research continues toward developing an universally acceptable, safe, and effective contraceptive to inhibit the female reproductive process. Progestational systems, either alone or in combination with small amounts of estrogen, approach such an ideal. The pregnane and 19-nortestosterone progestins were examined in this review with regard to contraceptive mechanisms of action and major side effects, such as menstrual abnormalities, metabolic changes, neoplasia, and teratogenicity. These steroids provide highly effective and long-acting contraception, and bypass the oral route of administration, resulting in fewer gastrointestinal and systemic side effects. Data regarding the lack of a deleterious effect of contraceptive progestogens on fetal malformation or cancer of the breast and genital tract reinforce their safety. Further study and refinement are needed, however, to lower the incidence of menstrual abnormalities, hypertension, and detrimental lipid alterations prior to approval for general use. Concern about side effects related to the estrogen component of oral contraceptives (OCs) has prompted investigation of progestogen-only contraceptives and of ways of delivering such progestational agents that will: 1) bypass the oral route and produce fewer gastrointestinal effects while allowing a lower dose of the steroid to be used since the 1st pass effect of hepatic degradation would not be a concern, 2) have a longer duration of action, and 3) produce less alterations in hormonal levels and fewer menstrual disturbances. This review examines the current status of long-acting progestogen-only agents (particularly pregnane and 19-nortestosterone) in terms of their mechanisms of action, metabolic changes, and other clinical effects. Irregular breakthrough bleeding, short or prolonged menstrual intervals, or prolonged menstrual bleeding are the side effects most commonly associated with the use of oral microdose progestogens. Also of concern is an association between some progestogens and the occurrence of arterial disease. A reduction in high-density lipoprotein cholesterol has been noted, which parallels the increasing rate of arterial disease and progestogen dose. On the other hand, data regarding the lack of a deleterious effect of progestogens on fetal malformation or cancer of the breast and genital tract reinforce their safety. Alternate delivery systems for contraceptive progestogens include injectables, subdermal implants, biodegradable systems, hormonal IUDs, and vaginal rings. Before progestogen-only contraceptives are made available for general use, however, there needs to be further study and refinement to lower the incidence of menstrual abnormalities, hypertension, and detrimental lipid alterations.
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