The comparative trial of the effects on various parameters of two 30 µg
EE monophasic oral contraceptives containing 0.3 mg norgestrel and 0.075 mg
E.Z. Tuzcular Vural, I. Gönen, G. Köse, N. Aka, P. Kumru
Department of Obstetrics and Gynecology, Haydarpasa Numune Training and
Research Hospital, Istanbul, Turkey
Aim: In this prospective study we aimed to compare and investigate the
safety, effects on various metabolic parameters and the acceptability by the
Turkish women of two monophasic 30 µg EE oral contraceptive (OC) pills, one
with 0,3 mg norgestrel, and the other with 0,075 mg gestodene.
Materials and Methods: The material of our study consisted of 72
healthy women who were randomly divided into two equal groups, among women who
applied to the Family Planning Unit of Haydarpasa Numune Training and Research
Hospital in Istanbul, Turkey, with a request of oral contraceptives. At the
initial, 3rd and 6th month visits blood pressure, fasting blood sugar, serum
total cholesterol, triglyceride, HDL, LDL, VLDL, hepatic enzyme levels were
measured and the two groups’ values were compared with student t and Mann
Whitney U tests.
Results: During the study period, none of the participants developed
pregnancies. The side effects (headache, nausea, spotting, breast tenderness)
were statistically similar in both groups, and did not cause discontinuation of
OC use. In the norgestrel group there was a statistically significant rise of
total serum cholesterol, triglyceride, LDL, VLDL, total cholesterol/HDL and LDL/
HDL levels. A statistically significant drop was observed in HDL levels. A
sudden increase was found in blood pressure and hepatic enzyme levels at the 6th
month visit. Although there was a rise in fasting blood sugar levels, it was not
statistically significant. In the gestodene group there was a statistically
significant increase in systolic blood pressure, fasting blood sugar, total
cholesterol, triglyceride, HDL, VLDL, AST, LDL/HDL, total cholesterol/HDL levels.
No statistically significant change occurred in the diastolic blood pressure,
LDL and ALT levels. While there was no statistically significant difference with
regard to blood pressure, total cholesterol, LDL, total cholesterol/HDL levels
between the two groups, we found a statistically significant difference in
fasting blood sugar and AST levels at the 3rd and 6th month evaluations and ALT,
HDL, LDL/HDL and triglyceride level differences only at the 6th month evaluation
for the gestodene group.
Conclusion: We conclude that the OCs containing gestodene have a more
favorable effect on the lipid profiles owing to its less androgenic properties.