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A comparison of Mirena use in women with and without fibroids - Mirena and Fibroids

A comparison of Mirena use in women with and without fibroids - Mirena and Fibroids

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-001461-40-GB
Enrollment
Unknown
Registered
2011-05-19
Start date
2011-10-28
Completion date
Unknown
Last updated
2012-06-26

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

Conditions

Menorrhagia

Interventions

Trade Name: Mirena IUS Product Name: Mirena IUS Pharmaceutical Form: Intrauterine delivery system

Sponsors

Hull and East Yorkshire Acute Hospitals NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All women who have chosen and who have been fitted with a Mirena IUS as a way of controlling their heavy periods and who have asked to be included in the study. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: Any woman unwilling to attend for blood samples and vaginal ultrasound scans.

Design outcomes

Primary

MeasureTime frame
Main Objective: We wish to establish whether women who require treatment for their heavy periods respond as favourably to the use of a Mirena IUS whether they have fibroids or not.;Secondary Objective: We wish to establish whether a Mirena IUS causes a reduction in the size of uterine fibroids;Primary end point(s): Bloodloss as determined by pictorial bloodloss assessment charts (PBAC)

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026