AID grant no. AID/CM/PHA-C-73-32 to the Southwest Foundation for Research and Education for a research and development program directed toward the safety of oral contraceptives in developing countries

The Southwest Foundation for Research and Education, San Antonio, TX, will conduct the research, which will consist of clinical trials in one or two developing countries. A total of 800-1,000 women will participate in the trials; care will be taken that participants represent the poorly nourished and chronically ill women who make up a high proportion of potential pill users in developing countries. Subjects will be randomly assigned to receive either IUD"s or one of at least two standard oral contraceptive preparations provided by A.I.D. for use in developing countries. The study will investigate the effects of the orals on fluid and electrolyte levels, carbohydrate and lipid metabolism, hepatic function, nutritional status, the pituitary gonadal axis, and changes in blood clotting, as well as their side effects. The Foundation will also develop a radioimmunoassay for measuring plasma levels of ethynyl estradiol.