A Canadian, multicentre study comparing the efficacy of a levonorgestrel-releasing intrauterine system to an oral contraceptive in women with idiopathic menorrhagia.
OBJECTIVE
To evaluate the efficacy of a levonorgestrel-releasing intrauterine system (LNG-IUS) compared with a combined oral contraceptive containing 1 mg norethindrone acetate and 20 mg ethinyl estradiol (OC1/20) in reducing menstrual blood loss (MBL) in women with idiopathic menorrhagia.


METHODS
A prospective, randomized, open-label study was conducted in nine centres in Canada. Healthy women over 30 years of age suffering from idiopathic menorrhagia were treated either with LNG-IUS (n = 20) or with OC1/20 (n = 19) over 12 months. The primary endpoint was the change in MBL from baseline to 12 months. Secondary endpoints included treatment success (defined as a MBL score < 100 after 12 months), hemoglobin levels, and the menorrhagia severity score.


RESULTS
In both treatment groups, MBL decreased significantly from baseline to 12 months (P < 0.001). For the primary endpoint, the MBL score decreased significantly more in the LNG-IUS group (median from 228 to 13, mean percent change-83%) compared to the OC1/20 group (median from 290 to 72; mean percent change-68%) (P = 0.002) after 12 months. In the LNG-IUS group, 80% of subjects had treatment success compared with 36.8 % in the OC1/20 group (P < 0.009). Both treatments increased hemoglobin concentrations significantly between baseline and 12 months. The menorrhagia severity score was consistently lower in the LNG-IUS group at all study time points and was significantly lower (P = 0.045) at six months. Both treatments were well tolerated.


CONCLUSIONS
Both the LNG-IUS and the combined oral contraceptive effectively decreased menstrual blood loss in women with idiopathic menorrhagia. The overall clinical benefit was more pronounced with LNG-IUS than with OC1/20.
Endrikat
Jan
J
Bayer Inc., Toronto ON; Universitätskliniken des Saarlandes, Frauenklinik, Germany.
Shapiro
Heather
H
University of Toronto, Mount Sinai Hospital, Toronto ON.
Lukkari-Lax
Eeva
E
Bayer Schering Pharma Oy, Espoo, Finland.
Kunz
Michael
M
Bayer Schering Pharma AG, Berlin, Germany.
Schmidt
Werner
W
Universitätskliniken des Saarlandes, Frauenklinik, Germany.
Fortier
Michel
M
Clinique de Recherche en Santé des Femmes, Obstetrics and Gynecology, Quebec City QC.
D000328:Adult; D002170:Canada; D003271:Contraceptive Agents, Female / Q000008:administration & dosage*; D003280:Contraceptives, Oral, Synthetic / Q000627:therapeutic use; D004967:Estrogens / Q000627:therapeutic use; D004997:Ethinyl Estradiol / Q000627:therapeutic use; D005260:Female; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D007436:Intrauterine Devices, Medicated; D016912:Levonorgestrel / Q000008:administration & dosage*; D008595:Menorrhagia / Q000188:drug therapy*; D009640:Norethindrone / Q000031:analogs & derivatives / Q000627:therapeutic use; D000077563:Norethindrone Acetate; D011446:Prospective Studies; D012720:Severity of Illness Index
D003271:Contraceptive Agents, Female; D003280:Contraceptives, Oral, Synthetic; D004967:Estrogens; D006454:Hemoglobins; D004997:Ethinyl Estradiol; D016912:Levonorgestrel; D000077563:Norethindrone Acetate; D009640:Norethindrone