Levonorgestrel‐impregnated intrauterine device as treatment for endometrial hyperplasia: a national multicentre randomised trial

Objective The purpose of this study was to investigate if the levonorgestrel‐impregnated intrauterine device (LNG‐IUS, Mirena®) is safe and effective as therapy for low‐risk and medium‐risk endometrial hyperplasia compared with oral medroxyprogesterone (MPA). Design A multicentre randomised trial. S...

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Bibliographic Details
Published in:BJOG : an international journal of obstetrics and gynaecology 2014-03, Vol.121 (4), p.477-486
Main Authors: Ørbo, A, Vereide, AB, Arnes, M, Pettersen, I, Straume, B
Format: Article
Language:English
Subjects:
Administration, Oral
Adult
Aged
Clinical outcomes
Clinical trials
Contraceptives, Oral, Synthetic - therapeutic use
Drug Administration Schedule
Drug therapy
Endometrial hyperplasia
Endometrial Hyperplasia - drug therapy
Female
Follow-Up Studies
Gynaecological Oncology
Gynecology
Humans
Intrauterine Devices, Medicated
Levonorgestrel - therapeutic use
levonorgestrel‐impregnated intrauterine device versus oral progestin
Medroxyprogesterone - therapeutic use
Middle Aged
Norway
Progestins - therapeutic use
Reproductive health
Risk
Single-Blind Method
therapy
Treatment Outcome
VDP
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Summary:Objective The purpose of this study was to investigate if the levonorgestrel‐impregnated intrauterine device (LNG‐IUS, Mirena®) is safe and effective as therapy for low‐risk and medium‐risk endometrial hyperplasia compared with oral medroxyprogesterone (MPA). Design A multicentre randomised trial. Setting Norway. Population In all, 170 women aged 30–70 years with low‐ or medium‐risk endometrial hyperplasia who met inclusion criteria. Methods Patients were randomly assigned to one of three treatment arms: LNG‐IUS; oral MPA 10 mg administered for 10 days per cycle, or continuous oral MPA 10 mg daily, for 6 months. Main outcome measures The primary outcome measure was normalisation or persisting hyperplasia. Results After 6 months all three treatment regimens showed significant effect when the outcome was evaluated as therapy response or not (P 
ISSN:1470-0328
1471-0528
DOI:10.1111/1471-0528.12499