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ISRCTN
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ISRCTN14156709
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ClinicalTrials.gov identifier
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Public title
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Pre-ablation endometrial preparation: a comparison between GnRH agonist leuporelin and GnRH antagonist Cetrorelix. A Randomised Controlled Trial.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0375157911
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Study hypothesis
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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)
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Surgery: Transcervical Endometrial Resection (TCRE)
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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1. Women on hormonal medications within last 3 months
2. Uterine size more than 12 weeks
3. Previous TCRE
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Anticipated start date
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31/10/2003
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Anticipated end date
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31/12/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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100
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Interventions
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Comparison between GnRH agonist leuporelin and GnRH antagonist Cetrorelix.
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Shrewsbury and Telford Research and Development Consortium (UK)
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Trial website
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Publications
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2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18715405
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Contact name
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Mr
B
Bentick
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Address
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Shrewsbury & Telford Hospital NHS Trust
Royal Shrewsbury Hospital
Mytton Oak Road
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City/town
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Shrewsbury
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Zip/Postcode
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SY3 8XQ
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Country
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United Kingdom
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Tel
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+44 (0)1743 261142
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Fax
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+44 (0)1743 261006
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Email
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Bernie.Bentick@rsh.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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01/10/2008
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Date ISRCTN assigned
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30/09/2005
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