RecruitingPhase 3ACTRN12608000029392

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


Sponsor

University of Sydney

Enrollment

300 participants

Start Date

Oct 1, 2009

Study Type

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

Sex: FemalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether inserting a Mirena intrauterine system (IUS) — a small hormonal device placed inside the uterus — after keyhole (laparoscopic) surgery helps reduce long-term pelvic pain and painful periods. Pelvic pain and period pain are very common in women and can significantly impact quality of life. Researchers want to see if the Mirena IUS can reduce these symptoms by at least half over 12 months following surgery. You may be eligible if: - You are a woman between 18 and 45 years of age - You have pelvic pain and/or painful periods (dysmenorrhoea) - You are scheduled for laparoscopic (keyhole) surgery to investigate or treat your pain You may NOT be eligible if: - You have an active pelvic infection (pelvic inflammatory disease) or a positive swab for chlamydia or gonorrhoea - You are breastfeeding - You are pregnant or planning to become pregnant within 12 months - You have previously had a hysterectomy - You have had hormonal treatment in the last 3 months - You have a known cancer or abnormal ovarian cysts (other than endometriotic cysts) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

Australia

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ACTRN12608000029392