Study in Women With Idiopathic Menorrhagia to Determine the Reduction in Menstrual Blood Loss (MBL) After Treatment With the Levonorgestrel-releasing Intrauterine System (IUS)

Summary

The purpose of this study is to determine whether the levonorgestrel-releasing intrauterine system is effective in decreasing menstrual blood loss.

Timeline

Start

2006-07

Primary completion

2008-06

Completion

2008-06

Outcome

Met primary endpoint

registry analysis (superiority or other test); Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours vs Medroxyprogesterone Acetate (MPA); p <0.001; Wilcoxon (Mann-Whitney) NCT00360490 ↗

paper the proportion of women with successful treatment was significantly higher for the levonorgestrel-releasing intrauterine system (84.8%) than for medroxyprogesterone acetate (22.2%, P < .001). PMID 20733445 ↗

Publications

• Results Endrikat J, Vilos G, Muysers C, Fortier M, Solomayer E, Lukkari-Lax E. The levonorgestrel-releasing intrauterine system provides a reliable, long-term treatment option for women with idiopathic menorrhagia. Arch Gynecol Obstet. 2012 Jan;285(1):117-21. doi: 10.1007/s00404-011-1902-1. Epub 2011 Apr 8.
• Results Kaunitz AM, Bissonnette F, Monteiro I, Lukkari-Lax E, DeSanctis Y, Jensen J. Levonorgestrel-releasing intrauterine system for heavy menstrual bleeding improves hemoglobin and ferritin levels. Contraception. 2012 Nov;86(5):452-7. doi: 10.1016/j.contraception.2012.07.018. Epub 2012 Sep 7.
• Results Kaunitz AM, Bissonnette F, Monteiro I, Lukkari-Lax E, Muysers C, Jensen JT. Levonorgestrel-releasing intrauterine system or medroxyprogesterone for heavy menstrual bleeding: a randomized controlled trial. Obstet Gynecol. 2010 Sep;116(3):625-632. doi: 10.1097/AOG.0b013e3181ec622b.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Levonorgestrel	Small molecule	20 ug	Other
Comparator	medroxyprogesterone acetate	Other / unclassified	10 mg	Oral

Indications