The same company that manufactures Depo-Provera manufactures Lunelle. It was approved for distribution in the United States by the FDA on 10-10-00.
Results of small, early studies showed no significant changes in serum levels of total cholesterol, triglycerides, or high-density lipoprotein cholesterol associated with monthly injections (3 to 12 months) when compared with pretreatment values. A later WHO study (World Health Organization) found no clinically significant changes in blood lipid levels. The same study reported minimal, and clinically insignificant, effects on the glucose or insulin response to the glucose challenge during the treatment and post-treatment periods. Minimal changes in liver function were reported, including a decrease in serum alkaline phosphatase levels and an increase in bilirubin levels without clinical significance. Among participants in the U.S. trial, users of MPA/E2C experienced a decrease in total cholesterol (C), total triglycerides, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and apolipoprotein (apo) A-I. Despite the decreases in HDL-C and apo A-I, the total C/HDL-C ratio was unchanged, suggesting minimal impact of these parameters on the overall trend toward improved cardiovascular (CVD) risk. Study results showed that the combined injectable did not induce pro-coagulant changes and did not have a significant effect on the fibrinolytic system. All changes observed were within the normal range and most had reversed within 3 months after discontinuation. The reported rate of serious adverse events in the U.S. trial was 1.9%. Three MPA/E2C users experienced serious adverse events related to the gall bladder (cholecystitis, cholelithiasis), two of which were judged to be drug-related. Three reported serious events related to depression and/or situational stress were judged to be unrelated to MPA/E2C. None of these serious adverse events resulted in discontinuation of the monthly injectable contraceptive. Risk of Neoplasia is also another concern.
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