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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000029392

Enrollment

300

Registered

2008-01-18

Start date

2009-10-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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).

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

All women with pelvic pain and or dysmenorrhoea

Exclusion criteria

1. Acute pelvic inflammatory disease (PID) and or positive swab for Chlamydia +/- Gonorrhea 2. Chronic PID as defined by the presence of tubal damage (hydrosalpinx, hydrosalpinges) noted at surgery 3. Breast feeding women 4. Positive pregnancy urinary test or plan for a pregnancy within 12 months after enrollment 5. Previous hysterectomy 6. Contraindications to laparoscopy and/or anesthesia 7. Contraindication to the use of IUS according to WHO criteria 8. Hormonal treatment within the last three months 9. Malignancies 10. Known ovarian cysts other than endometriotic 10. Intention to use other medical treatment that may affect pelvic pain scores within 12 month 11. Use of hormonal treatments in the last three months prior to trial recruitment

Outcome results