Mirena Intra-Uterine System: Does it Improve Long Term Symptoms in Women with Chronic Pelvic Pain and/or Endometriosis after Laparoscopy?
Mirena Intra-Uterine System: Does it Improve Long Term Symptoms in Women with Chronic Pelvic Pain and/or Endometriosis after Laparoscopy? A multicentre randomized placebo-controlled trial
University of Sydney
300 participants
Oct 1, 2009
Interventional
Conditions
Summary
The null hypothesis is: Women with pelvic pain and or dysmenorrhoea who undergo laparoscopy and insertion of Mirena IUS will have a reduction in symptoms of at least 50% at 12 months follow-up (primary point).
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
Mirena is a levonorgestrel-releasing intrauterine system, which consists of a T-shaped polyethylene frame (T-body) with a steroid reservoir. The reservoir consists of a cylinder, made of a mixture of levonorgestrel and silicone containing a total of 52 mg levonorgestrel. Low doses of levonorgestrel can be administered into the uterine cavity with the MIRENA intrauterine delivery system. Initially, levonorgestrel is released at a rate of approximately 20 µg/day. This rate decreases progressively to half that value after 5 years.
Locations(1)
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ACTRN12608000029392