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

• Conditions: Menorrhagia; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2011-001461-40-GB
• Lead Sponsor: Hull and East Yorkshire Acute Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-19
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)