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Evaluation of a new triphasic oral contraceptive in private practice

Contraception 34(5): 435-442

Evaluation of a new triphasic oral contraceptive in private practice

We evaluated the clinical and metabolic effects of a new triphasic regimen developed in the continuing attempt to reduce the dose of estrogen and progesteron in oral contraceptives. A combination of ethinyl estradiol (EE) and levonorgestrel (LNg) was used (six tablets with 30 .mu.g EE + 50 .mu.g LNg, five tablets with 40 .mu.g EE + 75 .mu.g LNg, and 10 tablets with 30 .mu.g EE + 125 .mu.g LNg), also known as Triphasil (Wyeth). In a private practice, 409 subjects participated in 7,286 treatment cycles. Three pregnancies occurred, all due to subject failure. Menstrual regulation was excellent and the incidence of side effects extremely low. Withdrawals from the study for possibly drug-related medical reasons totaled 9.0% through 56 cycles of treatment. Metabolic changes also were evaluated in 14 of these women over a 6-month period. The only statistically significant increased in carbohydrate values occurred at 6 months. The mean glucose level at 30 minutes of the oral glucose tolerance test was above the baseline mean value, but serum insulin levels showed no statistically significant deviation. Lipid values presented are total lipids, total cholesterol, triglycerides, .alpha.-, .beta.-, and pre-.beta.-lipoproteins, and high density and low density lipoprotein cholesterol. There was no statistically significant difference between the mean values at the baseline and those during treatment for any lipid variable. These results indicate that this triphasic oral contraceptives has a high degree of efficacy, a low incidence of side effects, excellent cycle control, and high subject compliance, and would seem to indicate a minimal influence on the metabolism of lipids and carbohydrates in the small number of subjects studied.

Accession: 005395451

PMID: 3102161

DOI: 10.1016/0010-7824(86)90053-3

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