SAFETY AND EFFICACY OF A COMBINED ORAL-CONTRACEPTIVE - GESTODENE 75 MU-G PLUS ETHINYL ESTRADIOL 30 MU-G IN MEXICAN WOMEN

An open prospective clinical trial designed to evaluate the efficacy a nd safety of the combined hormonal oral contraceptive (OC) containing 75 mu g gestodene plus 30 mu g ethinyl estradiol was undertaken in a M exican population. Sixty-nine healthy women of reproductive age took p art in the study for a total of 627 woman-months of observation. The c ombination of gestodene and ethinyl estradiol proved its effectiveness in preventing pregnancy during the study. Side-effects were minimal a nd regular endometrial bleeding patterns were observed during one year of continuous use of this OC preparation. The discontinuation rate fo r medical reasons was 11.6% at one year. Among a sample of 10 women, t he gestodene/ethinyl estradiol combination did not induce significant changes in the serum concentration of total cholesterol and LDL choles terol after 12 months of continuous administration. An increase in ser um triglycerides and HDL cholesterol was observed; this effect could b e attributed to a lack of androgenic and/or the intrinsic estrogenic b ehavior of gestodene. It can be concluded that this preparation is hig hly effective as a combined oral contraceptive; it is well tolerated a nd might offer some advantages with respect to other oral contraceptiv e combinations in its short- and medium-term impact on lipid metabolis m.