This 2-year study compared
Mesigyna(R) administered to 49 pre-menopausal women between 38 and 50 years, to 99 women fitted with an IUD (Nova-T). A complete
lipoprotein assessment was carried out before treatment and at 6, 12, and 24 months of treatment. A bone densitometry was performed on half of the women, and an endometrial biopsy was taken from half of the Meisgyna group before and at the end of the first and second year. No pregnancy occurred with
Mesigyna use while three pregnancies were observed with the IUD. The incidence of
bleeding anomalies was higher in the
Mesigyna group, with a discontinuation rate for these reasons of 20% versus 4% for IUD (p <0.05). The duration of
bleeding days as well as
dysmenorrhea were less with
Mesigyna. No differences were seen in the pattern of
intermenstrual bleeding and spinal bone density between both groups. No patient developed
endometrial hyperplasia after treatment, thus endometrial risk seemed not to be increased. Total and
LDL cholesterol, and
apolipoproteins did not show modifications. A slight decrease in total
triglycerides, HDL and
HDL(2) cholesterol, and
IDL lipoproteins was observed with
Mesigyna. The present study appears to be the first using a monthly
injectable hormonal
contraceptive and monitoring its influence on
lipid patterns in premenopausal women.
Mesigyna proved to be a highly effective and low risk agent for premenopausal users.