Second Report on the Oral Contraceptives

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Page 8 - An annual conference of scientific writers on contraceptive knowledge and accomplishment be held under auspices of the Food and Drug Administration or the Department of Health, Education and Welfare. Years ago the American Cancer Society sought by means of annual conferences of science writers to make available data on research, treatment and etiology of malignant disease. These conferences made for a vastly better informed press. In view of the public interest in population and its control similar...
Page 15 - Ovarian follicle development appears, nevertheless, to proceed so that endogenous estrogen production may not be completely obliterated. The endometrial pattern, however, reveals that the established estrogenprogestin balance is far from normal. As a result, uterine bleeding is totally unpredictable for women on this regimen. There is considerable patient variation but by the end of a year the majority of women have atrophic endometria and are amenorrheic. An extremely low pregnancy rate has been...
Page 16 - ... of the zygote, or the preparation of the endometrium for nidation. Histologic evidence from biopsy material suggests that endometrial changes are not responsible for the antifertility effect.
Page 15 - The investigation is aimed at calibrating the oral dose of the combination that will result in a month-long release of steroid from the adipose tissue at a level that will suppress ovulation while maintaining an acceptable endometrial bleeding pattern.
Page 15 - This, and others that are likely to emerge, will have to be evaluated independently to establish their performance statistics. Hormonal suppression of ovulation Oral preparations Pharmaceutical firms continue to investigate different combinations or doses of synthetic progestins and synthetic estrogens in an effort to reduce side effects of antiovulant therapy, while maintaining a high degree of effectiveness. The progestogenic dose has gradually been reduced from over 9 mg in the original preparations...
Page 15 - ... tiveness. The dose of progestin has gradually been reduced from over 9 mg. in the original preparations to 0.5 mg. The dose of estrogen, ethinyl estradiol or its three-methyl-ether, has been reduced from 0.15 mg. in the first marketed product to 0.05 mg. It is not yet possible to draw conclusions concerning the various newer dosage combinations with respect to either efficacy or side effects. The combination product introduced most recently contains 0.5 mg. of a synthetic progestin, norgestrel,...
Page 31 - Sixty-seven cases and 23 controls had used these products until within one month before they were hospitalized ; 11 cases and controls had discontinued use earlier. Duration of use did not affect the risk. There were 57 case-control pairs in which only the case had used an oral contraceptive within one month compared to 13 in which only the control had done so. The relative risk of thromboembolism for the users is estimated to be 4.4 times that of nonusers. The risk was higher for users of sequential...
Page 69 - The Metabolic Effects of Gonadal Steroids and Contraceptive Agents" (147). This comparatively brief Task Force report does not attempt to include all of the extensive literature on the biological effects of oral contraceptives but identifies certain topics that the Task Force believes to be of particular importance. The effects of these agents on blood coagulation and thromboembolism are covered in another portion of the report. It is clear, however, that oral contraceptives have many varied effects...
Page 63 - ... conceive and bear. Laboratory studies of carbohydrate metabolism, hepatic and thyroid function, and other body functions have, in some instances, revealed deviations from normal values. The evaluation of the significance of these changes for the health of the individual requires further study. In 1969 a survey of women attending the clinics of Planned Parenthood of New York City revealed a higher prevalence of epithelial abnormalities, diagnosed as carcinoma in situ, among women using OCs compared...
Page 2 - The risk of thromboembolism associated with the oral contraceptives has been compared with that from pregnancy, cigarette smoking, and automobile accidents. Such comparisons are probably irrelevant, contributing little to evaluation of the relative risk. The task of balancing the risk against the benefit to the individual and to society must eventually be met. As contraceptive practices spread to all segments of our society, it becomes virtually essential that the requirements of effectiveness and...

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