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Trial registered on ANZCTR


Registration number
ACTRN12618000677202
Ethics application status
Approved
Date submitted
15/01/2018
Date registered
26/04/2018
Date last updated
26/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mirena for treatment of polyps
Scientific title
The role of the Mirena Intrauterine Device(LNG-IUD) in the management of endometrial polyps – a case control study.
Secondary ID [1] 293771 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial polyps 306169 0
Condition category
Condition code
Reproductive Health and Childbirth 305281 305281 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To test the hypothesis that the LNG-IUD over a two month period by an endosurgical consultant(OB/GYN) can have a role in the treatment of endometrial polyps confirmed at outpatient hysteroscopy in premenopausal women.
It is an intrauterine device that is inserted into the uterus
It lasts 5years and released 20mcg of levonorgestrel daily
In the study the mirena was kept in for two months until they went on to have an inpatient hysteroscopy.
Intervention code [1] 300027 0
Not applicable
Comparator / control treatment
A contemporaneous control was taken sequentially from the outpatient hysteroscopy database to match the case.
Control group
Active

Outcomes
Primary outcome [1] 304438 0
Presence of polyp at second procedure at the time of hysteroscopy. Two months after insertion of the mirena at the time of general anaesthetic
Timepoint [1] 304438 0
2 months post outpatient hysteroscopy
Secondary outcome [1] 341934 0
no secondary outcome
Timepoint [1] 341934 0
No outcome timepoint as no secondary outcome

Eligibility
Key inclusion criteria
Patients attending the MHW outpatient hysteroscopy clinic who were premenopausal, English speaking, over 18, with abnormal uterine bleeding and ultrasound findings suggestive of an endometrial polyp and no contraindications to the LNG IUD were approached for participation into the study. Patients who consented to participation and subsequently were proven to have an endometrial polyp on outpatient hysteroscopy were eligible for inclusion.
Control group also had to meet the same eligibility criteria as above.
Minimum age
18 Years
Maximum age
50 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with an inadequate grasp of English, were less than 18 years old or had a medical contraindication to the LNG-IUD were not eligible for the study.
Patients unable to give informed consent or declining participation into the study were excluded, underwent standard treatment and were not disadvantaged or delayed in any way.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9752 0
Mercy Hospital for Women - Heidelberg
Recruitment postcode(s) [1] 18530 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 298388 0
Hospital
Name [1] 298388 0
Mercy Hospital for Women
Address [1] 298388 0
163 Studley Rd, Heidelberg VIC 3084, Australia
Country [1] 298388 0
Australia
Primary sponsor type
Hospital
Name
Mercy hospital for Women
Address
163 Studley Rd, Heidelberg VIC 3084, Australia
Country
Australia
Secondary sponsor category [1] 297516 0
None
Name [1] 297516 0
None
Address [1] 297516 0
No address provided as no secondary sponsor
Country [1] 297516 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299381 0
Mercy health HREC
Ethics committee address [1] 299381 0
163 Studley Rd, Heidelberg VIC 3084, Australia
Ethics committee country [1] 299381 0
Australia
Date submitted for ethics approval [1] 299381 0
03/12/2014
Approval date [1] 299381 0
21/01/2015
Ethics approval number [1] 299381 0
Mercy health HREC R14/17

Summary
Brief summary
Objective – To test the hypothesis that the LNG-IUD can have a role in the treatment of endometrial polyps confirmed at outpatient hysteroscopy in premenopausal women.

Design - We designed a case control study, in which premenopausal women who had a polyp diagnosed at outpatient hysteroscopy and had a LNG-IUD inserted were booked for GA hysteroscopy and polypectomy through the standard booking process. A contemporaneous control was taken sequentially from the outpatient hysteroscopy database to match the case.

Results - A total of 39 patients were included in the study, with 19 in the exposed group and 20 in the control group. The mean age was 43.6 (SD = 5.6) and 43.2 (SD = 8.1) in the two groups, respectively. No difference was found in time interval between the two procedures in the intervention and control groups (mean 92 vs 84 days, p=0.73). However, the proportion of polyps present at second procedure was significantly higher in the control group (80% vs 37%; relative risk (RR) 2.17; 95% CI [1.16, 4.07]; p=0.0062).

Conclusion – Our case control study found that the LNG-IUD can have a role in the treatment of polyps for women who have heavy menstrual bleeding. This is the first study to show regression of endometrial polyps post treatment with LNG-IUD by direct visualisation at hysteroscopy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80234 0
Dr Prathima Chowdary
Address 80234 0
Mercy Health for Women
163 Studley Rd, Heidelberg VIC 3084, Australia
Country 80234 0
Australia
Phone 80234 0
+61474033777
Fax 80234 0
Email 80234 0
prath1mak@yahoo.co.in
Contact person for public queries
Name 80235 0
Dr Prathima Chowdary
Address 80235 0
Mercy Health for Women
163 Studley Rd, Heidelberg VIC 3084, Australia
Country 80235 0
Australia
Phone 80235 0
+61474033777
Fax 80235 0
Email 80235 0
prath1mak@yahoo.co.in
Contact person for scientific queries
Name 80236 0
Dr Prathima Chowdary
Address 80236 0
Mercy Health for Women
163 Studley Rd, Heidelberg VIC 3084, Australia
Country 80236 0
Australia
Phone 80236 0
+61474033777
Fax 80236 0
Email 80236 0
prath1mak@yahoo.co.in

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary