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 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
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
-
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.