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A randomised controlled trial comparing endometrial ablation plus levonorgestrel releasing intrauterine system versus endometrial ablation alone in women with heavy menstrual bleeding.

A randomised controlled trial comparing endometrial ablation plus levonorgestrel releasing intrauterine system versus endometrial ablation alone in women with heavy menstrual bleeding (MIRA 2 trial).

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25628
Enrollment
718
Registered
2019-06-20
Start date
2019-10-01
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

Heavy menstrual bleeding Dysmenorroea

Interventions

Endometrial ablation and LNG-IUS combined.

Sponsors

Máxima Medical Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Women suffering from heavy menstrual bleeding, who do not wish or benefit from another treatment for heavy menstrual bleeding (medication or LNG-IUS) and opt for treatment with EA, irrespective of the existence of fibroids, polyps or adenomyosis. Earlier use of LNG-IUS is no exclusion.

Exclusion criteria

Exclusion criteria: • Women who don’t speak Dutch or English to a standard that they can fully understand the study and complete the trial questionnaires. • Women who might want to get pregnant in the future will not be included since an endometrium ablation interferes with future pregnancies. • Suspicion on endometrial cancer. • Contra-indications for levonorgestrel IUD. • Already performed Eandometrial Ablation.

Design outcomes

Primary

MeasureTime frame
Hysterectomy rate after 2 years of follow-up.

Secondary

MeasureTime frame
Patient satisfaction, PBAC-score, quality of life, cyclic and non-cyclic pelvic pain, re-interventions, complications, side-effects and cost-effectiveness.

Contacts

Public ContactTamara Oderkerk

Maxima Medisch Centrum

tamara.oderkerk@mmc.nl0408888384

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)