ClinicalTrialsFinder
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

Chronic Pelvic Pain in women in reproductive age

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

Inclusion Criteria1

  • All women with pelvic pain and or dysmenorrhoea

Exclusion Criteria12

  • Acute pelvic inflammatory disease (PID) and or positive swab for Chlamydia +/- Gonorrhea
  • Chronic PID as defined by the presence of tubal damage (hydrosalpinx, hydrosalpinges) noted at surgery
  • Breast feeding women
  • Positive pregnancy urinary test or plan for a pregnancy within 12 months after enrollment
  • Previous hysterectomy
  • Contraindications to laparoscopy and/or anesthesia
  • Contraindication to the use of IUS according to WHO criteria
  • Hormonal treatment within the last three months
  • Malignancies
  • Known ovarian cysts other than endometriotic
  • Intention to use other medical treatment that may affect pelvic pain scores within 12 month
  • Use of hormonal treatments in the last three months prior to trial recruitment

Interested in this trial?

Get notified about updates and connect with the research team.

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

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12608000029392