Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
01/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr B Bentick

ORCID ID

Contact details

Shrewsbury & Telford Hospital NHS Trust
Royal Shrewsbury Hospital
Mytton Oak Road
Shrewsbury
SY3 8XQ
United Kingdom
+44 (0)1743 261142
Bernie.Bentick@rsh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0375157911

Study information

Scientific title

Acronym

Study hypothesis

To compare the effects of GnRH antagonist Cetrorelix (Cetrocide) and GnRH agonist Leuprorelin (Prostap SR) injections for preoperative endometrial preparation, prior to Transcervical Endometrial Resection (TCRE)

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Surgery: Transcervical Endometrial Resection (TCRE)

Intervention

Comparison between GnRH agonist leuporelin and GnRH antagonist Cetrorelix.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

1. Endometrial thickness as measured on trans-vaginal ultrasound (sagittal plane) on the day of operation
2. Histological assessment of "endometrial chippings"
3. Comparison of side effect profile
4. Operative difficulties
5. Overall patient satisfaction

Secondary outcome measures

Not provided at time of registration

Overall trial start date

31/10/2003

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

100 eligible women will be identified from those already on the waiting list for Transcervical Endometrial Resection (TCRE).
They will be suitable candidates for the procedure and those with submucous fibroid will not be excluded.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

1. Women on hormonal medications within last 3 months
2. Uterine size more than 12 weeks
3. Previous TCRE

Recruitment start date

31/10/2003

Recruitment end date

31/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Shrewsbury & Telford Hospital NHS Trust
Shrewsbury
SY3 8XQ
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Shrewsbury and Telford Research and Development Consortium (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18715405

Publication citations

  1. Results

    Bhatia K, Doonan Y, Giannakou A, Bentick B, A randomised controlled trial comparing GnRH antagonist cetrorelix with GnRH agonist leuprorelin for endometrial thinning prior to transcervical resection of endometrium., BJOG, 2008, 115, 10, 1214-1224, doi: 10.1111/j.1471-0528.2008.01837.x.

Additional files

Editorial Notes