Levonorgestrel releasing intrauterine system (Mirena) versus endometrial ablation (Novasure) in women with heavy menstrual bleeding: a multicentre randomised controlled trial.
BACKGROUND
Heavy menstrual bleeding is an important health problem. Two frequently used therapies are the levonorgestrel intra-uterine system (LNG-IUS) and endometrial ablation. The LNG-IUS can be applied easily by the general practitioner, which saves costs, but has considerable failure rates. As an alternative, endometrial ablation is also very effective, but this treatment has to be performed by a gynaecologist. Due to lack of direct comparison of LNG-IUS with endometrial ablation, there is no evidence based preferred advice for the use of one of these treatment possibilities.


METHODS
A multicenter randomised controlled trial, organised in a network infrastructure in the Netherlands in which general practitioners and gynaecologists collaborate.


CONCLUSIONS
This study, considering both effectiveness and cost effectiveness of LNG-IUS versus endometrial ablation may well improve care for women with heavy menstrual bleeding.


BACKGROUND
Dutch trial register, number NTR2984.
Malou C
MC
Herman
Marian J
MJ
van den Brink
Peggy M
PM
Geomini
Hannah S
HS
van Meurs
Judith A
JA
Huirne
Heleen P
HP
Eising
Anne
A
Timmermans
Johanna M A
JM
Pijnenborg
Ellen R
ER
Klinkert
Sjors F
SF
Coppus
Theodoor E
TE
Nieboer
Ruby
R
Catshoek
Lucet F
LF
van der Voet
Hugo W F
HW
van Eijndhoven
Giuseppe C M
GC
Graziosi
Sebastiaan
S
Veersema
Paul J
PJ
van Kesteren
Josje
J
Langenveld
Nicol A C
NA
Smeets
Huib A A M
HA
van Vliet
Jan Willem
JW
van der Steeg
Yvonne
Y
Lisman-van Leeuwen
Janny H
JH
Dekker
Ben W
BW
Mol
Marjolein Y
MY
Berger
Marlies Y
MY
Bongers
D000328:Adult; D003271:Contraceptive Agents, Female / Q000008:administration & dosage*; D055356:Endometrial Ablation Techniques / Q000379:methods*; D005260:Female; D006801:Humans; D007436:Intrauterine Devices, Medicated / Q000706:statistics & numerical data*; D016912:Levonorgestrel / Q000008:administration & dosage*; D009426:Netherlands; D016896:Treatment Outcome; D016387:Women's Health; D055815:Young Adult
D003271:Contraceptive Agents, Female; D016912:Levonorgestrel