Therapeutic Equivalence Trial of Two Hormonal-IUDs in Patients With Heavy Menstrual Bleeding
Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study was to compare the efficacy of Test Product (Levosert)
vs. Reference Product (Mirena® Bayer-Schering) based on the mean variation of menstrual blood
loss volume in women with menorrhagia.
The secondary objectives includes physical and gynaecological examinations, vital signs,
clinical laboratory tests including hemoglobin and ferritin measurements, body weight and
spontaneously reported adverse events were analysed and compared between Levosert and Mirena®
treatment arms. Plasma levels of levonorgestrel (LNG) were also evaluated after various
periods of time. The residual amounts of LNG in the devices were finally measured after
withdrawal at completion of the study. Plasma levels of LNG and residual amounts of LNG were
compared between the two treatment groups. Contraceptive effect of Levosert was estimated by
Pearl Index.