Document Detail

Efficacy, acceptability and side effects of the levonorgestrel intrauterine system for menorrhagia.
MedLine Citation:
PMID:  17382331     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To evaluate the efficacy, acceptability, and possible side effects of a levonorgestrel-releasing intrauterine system for menorrhagia. METHODS: Sixty-three women with menorrhagia but without uterine enlargement, endometrial hyperplasia with atypia, or endometrial carcinoma were enrolled in this prospective, open, nonrandomized clinical trial. An intrauterine system releasing 20 microg/day of levonorgestrel (LNG-IUS; Mirena, Shering, Finland) was inserted in the postmenstrual phase. Menstrual pattern, number of bleeding days, and subjective and objective estimation of menstrual blood loss using a pictorial blood loss assessment chart (PBAC) were recorded before insertion and at specific intervals for 4 years. Hemoglobin levels and endometrial thickness were evaluated at baseline and at 12 months. Treatment continuation and hysterectomy rates were noted as well as side effects. RESULTS: The device was expelled spontaneously in 6 patients (9.52%) and removed prematurely in 9 patients (14.3%); 3 patients (4.8%) were lost to follow-up; and 45 patients (71.4%) continued with the LNG-IUS. Menorrhagia was cured in 35 (77.7%) of these 45 patients at 3 months and in all patients at 36 months. There was a significant decrease in the mean number of bleeding days (P=0.01) and PBAC score (P=0.00) at 1 month, and the decrease continued with treatment duration. The subjective blood loss reduction was considerable as well, and at 12 months the mean+/-SD rise in hemoglobin concentration was 1.06+/-1.7 g/dL (P=0.000). Endometrial thickness was decreased by 3.4+/-3.53 mm (P=0.0001) at 12 months. The most common side effect was intermenstrual spotting during the first 6 months, and 18 patients (28.57%) developed amenorrhea. CONCLUSION: Using the LNG-IUS is an effective and well-accepted option overall for the medical management of menorrhagia.
A Kriplani; B M Singh; S Lal; N Agarwal
Publication Detail:
Type:  Clinical Trial; Journal Article     Date:  2007-03-26
Journal Detail:
Title:  International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics     Volume:  97     ISSN:  0020-7292     ISO Abbreviation:  Int J Gynaecol Obstet     Publication Date:  2007 Jun 
Date Detail:
Created Date:  2007-05-21     Completed Date:  2007-08-16     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0210174     Medline TA:  Int J Gynaecol Obstet     Country:  Ireland    
Other Details:
Languages:  eng     Pagination:  190-4     Citation Subset:  IM    
Department of Obstetrics and Gynecology, All-India Institute of Medical Sciences, New Delhi, India.
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MeSH Terms
Contraceptive Agents, Female / administration & dosage*,  adverse effects
Endometrium / drug effects*,  pathology
Follow-Up Studies
Intrauterine Devices, Medicated*
Levonorgestrel / administration & dosage*,  adverse effects
Menorrhagia / drug therapy*
Middle Aged
Patient Satisfaction
Prospective Studies
Treatment Outcome
Reg. No./Substance:
0/Contraceptive Agents, Female; 797-63-7/Levonorgestrel

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