Colorimetric determination of ethinyl estradiol in oral contraceptive formulations.
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OBJECTIVE: To review the literature to determine the magnitude of the effect of 150 micrograms desogestrel-30 micrograms ethinyl E2, an oral contraceptive (OC) formulation, on plasma lipid concentrations in healthy women using meta-analysis techniques. DATA SOURCES: All English-language published reports (1981 to 1991) on lipid parameters in women taking 150 micrograms desogestrel and 30 micrograms ethinyl E2 for up to 6 months obtained via an Embase database search and via a subsequent review of the reference lists. METHODS OF STUDY SELECTION: Of 98 articles, 18 met eligibility criteria and were included in the meta-analysis. DATA EXTRACTION AND SYNTHESIS: Data on total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and triglycerides were extracted. The change in each parameter from baseline to cycle 6 was estimated as a weighted mean of changes reported in each study; a standard error of the estimate was calculated. This procedure was validated by goodness-of-fit tests. RESULTS: The following statistically significant changes from baseline to cycle 6 were estimated (mean +/- SE): HDL-C: 0.15 +/- 0.02 mmol/L (5.80 +/- 0.62 mg/dL); triglycerides: 0.28 +/- 0.03 mmol/L (24.49 +/- 2.59 mg/dL); and LDL: - 0.12 +/- 0.04 mmol/L (-4.53 +/- 1.55 mg/dL). There was a nonsignificant trend toward an increase in total cholesterol. CONCLUSION: When given in combination with 30 micrograms ethinyl E2, desogestrel increased HDL-C and triglycerides and decreased LDL-C. The positive impact on HDL-C and LDL-C suggests that a potential cardioprotective benefit (rather than an atherosclerosis risk) may occur with prolonged use of such an OC, but this hypothesis will be difficult to prove.
A comparative study of the effects of a monophasic and a triphasic oral contraceptive containing ethinylestradiol (EE) and levonorgestrel (LNG) on lipid and lipoprotein metabolism was conducted on 45 Singapore women under the WHO Special Programme of Research in Human Reproduction. The women were randomly allocated to one of the two pill groups--a triphasic preparation containing low doses of LNG and EE in various proportions and a monophasic preparation of 150 micrograms LNG and 30 micrograms EE, and an additional 18 women, choosing to use IUDs, were recruited as controls. Blood samples were taken at admission, 3 and 12 months thereafter. For both pill groups, total cholesterol decreased with duration of use, while HDL cholesterol decreased slightly at 3 months and thereafter increased. LDL cholesterol decreased slightly at 3 months, returning to baseline at 12 months for the monophasic group, while remaining unchanged at 12 months for the triphasic group. The monophasic preparation appeared to lower total, LDL and HDL cholesterols to a greater extent at 3 months than the triphasic preparation. Compared with IUD users, for the monophasic group, both total and HDL cholesterols were significantly lower at 3 months and HDL and LDL cholesterols were lower at 12 months. In addition, ratios of HDL cholesterol/LDL cholesterol and HDL cholesterol/total cholesterol were significantly lower at 12 months. Changes in triglycerides were minimal for both pill groups. However, at 3 months, triglycerides for the triphasic group were significantly higher than the IUD users, but this observation was not of any clinical importance since comparison of changes with their respective pretreatment values were not statistically significant. These results indicate that these changes are related to the dosage and estrogen-progestogen ratio of the preparation. Furthermore, the monophasic preparation may have a disadvantage over the triphasic preparation since it appears to cause more disturbance in lipid metabolism. However, it is noted that these changes in lipids and lipoproteins were minimal and did not appear to be of any clinical significance.
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