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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41545

Enrollment

266

Registered

2012-03-08

Start date

2012-04-27

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Heavy menstrual bleeding Menorrhagia

Interventions

We will assess cost-effectiveness of two methods that are frequently used in daily practice: a strategy starting with a levonorgestrel releasing intrauterine system versus a strategy starting with e

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Primary outcome is the mean blood loss at 24 months of follow-up, measured with a PBAC-score.	—

Secondary

Measure	Time frame
Secondary outcomes are patient satisfaction, complications, number of re-interventions, menstrual bleeding pattern, including rates of amenorrhea, proportion of women with a PBAC-score	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)