Mirena and Fibroids

• Research type

  Research Study

• Full title

  A comparison of Mirena use in women with and without fibroids

• IRAS ID

  74414

• Contact name

  Stephen Killick

• Eudract number

  2011-001461-40

• ISRCTN Number

  N/A

• Research summary

  We plan to follow women who have been fitted with a Mirena intrauterine system as a means of controlling their heavy periods. In particular we wish to establish whether the response to treatment is flunced by the presence of fibroids.We therefore plan to perform an ultrasound scan on women who have had a Mirena inserted and record and measure any fibroids. The response to therapy will be assessed using quality of life questionnaires, a pictorial bloodloss assessment chart (PBAC) changes in haemoglobin values any change in fibroid size and first year continuation rates. Responses will be compared between women with and without fibroids.The study will last for 1 year for each participant and requires two vaginal ultrasound scans, two blood tests and the completion of questionnaires on 3 occasions.Results should enable us to predict who will respond best to the insertion of a Mirena and who might be better to opt for other ways of controlling their heavy periods such as hormone therapy, endometrial ablation, myomectomy or hysterectomy.

• REC name

  North East - York Research Ethics Committee

• REC reference

  11/NE/0311

• Date of REC Opinion

  28 Oct 2011

• REC opinion

  Favourable Opinion