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).

Recruiting

• Conditions: dysmenorrhoea; pelvic pain; 10013326

• Registration Number: NL-OMON54839
• Lead Sponsor: Maxima Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 718

Inclusion Criteria

Women suffering from heavy menstrual bleeding, who opt for treatment with EA,
irrespective of the existence of fibroids, polyps or adenomyosis.

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 with a (future) childwish
- Women with a suspicion on endometrial cancer.
- Women with contra-indications for levonorgestrel IUD.
- Women with an already performed Endometrial Ablation.
- Women over 60 years old.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary: hysterectomy rate after 2 years of follow-up. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Patient satisfaction, PBAC-score, quality of life, cyclisch and non-cyclic<br /><br>pelvic pain, side-effects, re-interventions, complications and<br /><br>cost-effectiveness.</p><br>