A placebo controlled trial of medical treatment of submucous fibroids with gonadotropin releasing hormone (GnRH) analogues prior to hysteroscopic resection.

ISRCTN ISRCTN06560767
DOI https://doi.org/10.1186/ISRCTN06560767
Secondary identifying numbers N0116148335
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
18/08/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr D Jurkovic
Scientific

Department of Obstetrics and Gynaecology
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom

Study information

Study designDouble blind randomised placebo controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesTo evaluate whether pre-operative treatment with gonadotropin releasing hormone (GnRH) analogues prior to hysteroscopic resection of submucous fibroids increases the success of surgery.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Gynaecological
InterventionWomen undergoing TCRM will be randomised to receive pre-operative treatment with gonadotropin releasing hormone (GnRH) or placebo.
The duration of follow up was 6 weeks, post operatively
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)gonadotropin releasing hormone (GnRH)
Primary outcome measureAdded 18/08/10:
Completeness of fibroid resection
Secondary outcome measuresAdded 18/08/10:
1. Duration of the TCRM
2. Fluid deficit recorded at TCRM
3. Resolution of symptoms post-operatively
4. Number of subsequent fibroid related operations
Overall study start date01/02/2003
Completion date01/12/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants47 (added 18/08/10; see publication)
Key inclusion criteriaAdded 18/08/10:
1. Women found to have submucous fibroids on three-dimensional saline infusion sonohysterography (3D SIS)
2. Removal of fibroids by hysteroscopic transcervical resection of myoma (TCRM)
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment01/02/2003
Date of final enrolment01/12/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Obstetrics and Gynaecology
London
SE5 9RS
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Kings College Hospital NHS Trust R&D Consortium (UK) - NHS R&D support funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2010 Yes No