RCT comparing the levonorgestrel releasing intrauterine system (Mirena) versus endometrial ablation in women suffering from menorrhagia

Completed

• Conditions: Menorrhagia; 10013326; Heavy menstrual bleeding; 10064477

• Registration Number: NL-OMON41545
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 266

Inclusion Criteria

Women suffering from menorrhagia, with a Pictorial Blood Assessment Chart (PBAC) exceeding 150 points

Exclusion Criteria

*the desire to have (more) children
*Women with an abnormal uterine cavity (myomas, polyps) determined by a transVaginalUltrasound (TVU)
* Women with large intramural myoma determined by a TVU
* Women younger than 34 years
* Sound length more than 10 cm measured at TVU
* Uterine size exceeding 10 weeks of gestation by bimanual manipulation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is the mean blood loss at 24 months of follow-up, measured with<br /><br>a PBAC-score. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are patient satisfaction, complications, number of<br /><br>re-interventions, menstrual bleeding pattern,<br /><br>including rates of amenorrhea, proportion of women with a PBAC-score <75,<br /><br>quality of life, sexual function, presence of lower levels of coagulation<br /><br>levels, sick leave and costs.</p><br>