Levonorgestrel-releasing intrauterine system compared to low dose combined oral contraceptive pills for idiopathic menorrhagia: a randomized clinical trial.
BACKGROUND
This study compared the efficacy of the levonorgestrel-releasing intrauterine system (LNG-IUS) to low dose combined oral contraceptive pills (COC) in the management of idiopathic menorrhagia.


METHODS
A single-center, open, randomized clinical trial. One hundred twelve women complaining of excessive menstruation who desired contraception were randomized to receive LNG-IUS or COC. Treatment failure was defined as the need for medical or surgical treatment during the follow-up. Other outcomes included: menstrual blood loss (MBL) by alkaline hematin and by pictorial blood assessment chart (PBLAC), hemoglobin levels and assessment of lost days in which physical or mental health prevented participating women from performing usual activities.


RESULTS
At baseline, LNG-IUS (n=56) and COC (n=56) groups were comparable in age (mean ± S.D.) (39.3 ± 6.7 vs. 38.7 ± 5.2 years, p=.637), parity (median and range) [3(1-6.4) vs.3(2-6), p=.802] and BMI (mean ± S.D.) (29.6 ± 5.9 vs. 31.1 ± 5.7 kg/m(2), p=.175). Time to treatment failure was longer in LNG compared to COC group with a total of 6 (11%) patients who had treatment failure in the LNG-IUS compared to 18 (32%) in COC group with a hazard ratio of 0.30 (95% CI, 0.15-0.73, p=.007). Using alkaline hematin, the reduction in MBL (mean ± S.D.) was significantly more in the LNG-IUS group (87.4 ± 11.3%) compared to the COC group (34.9 ± 76.9%) (p=.013). Utilizing PBLAC scores, the reduction in the LNG-IUS (86.6 ± 17.0%) group was significantly more compared to the COC group (2.5 ± 93.2%) (p<.001). In the LNG-IUS group, increase in the hemoglobin and ferritin levels (mean ± S.D.) were noted (from 10.2 ± 1.3 to 11.4 ± 1.0 g/dL; p<.001; with reduction of the number of lost days (from 6.8 ± 2.6 to 1.6 ± 2.4 days, p=.003).


CONCLUSIONS
The LNG-IUS is a more effective therapy for idiopathic menorrhagia compared to COC.
Faculty of Medicine, Department of Obstetrics and Gynecology, Assiut University, Assiut 71526, Egypt.
Mamdouh M
MM
Shaaban
Mamdouh M
MM
Shabaan
Mahmoud S
MS
Zakherah
Sherif A
SA
El-Nashar
Gamal H
GH
Sayed
D000328:Adult; D003276:Contraceptives, Oral / Q000008:administration & dosage*; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage*; D005260:Female; D005293:Ferritins / Q000097:blood; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007436:Intrauterine Devices, Medicated; D053208:Kaplan-Meier Estimate; D016912:Levonorgestrel / Q000008:administration & dosage*; D008595:Menorrhagia / Q000097:blood / Q000188:drug therapy*; D008875:Middle Aged; D011788:Quality of Life; D055815:Young Adult
D003276:Contraceptives, Oral; D003277:Contraceptives, Oral, Combined; D006454:Hemoglobins; D016912:Levonorgestrel; D005293:Ferritins