A placebo controlled trial of medical treatment of submucous fibroids with Gonadotrophin Releasing Hormone (GnRH) analogues prior to hysteroscopic resection

ISRCTN ISRCTN75436772
DOI https://doi.org/10.1186/ISRCTN75436772
Secondary identifying numbers N/A
Submission date
23/08/2005
Registration date
30/11/2005
Last edited
15/05/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Davor Jurkovic
Scientific

King's College Hospital
Denmark Hill
London
SE 5 8RX
United Kingdom

Study information

Study designRandomised double blind placebo controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesSubmucous fibroids are benign tumours of the smooth muscle cells of the uterus. They are found in at least 20 - 25% of women over the age of 35 years although they may be as frequent as 50%. Fibroids are the most common identifiable cause of excessive menstrual blood loss in reproductive age.

Hypothesis:
To evaluate whether preoperative treatment with 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) studiedSubmucous fibroids
InterventionThis randomised double blind placebo controlled trial will include women referred for ultrasound assessment because of a history of excessive menstrual bleeding. Those found on ultrasound examination to have submucous fibroids who fulfil the inclusion criteria will be invited to join the study. Each woman will be randomised to either treatment or placebo group. The treatment group will be 3.6 mg goserelin in a single dose syringe and the placebo group will be 5 ml of 1% lignocaine administered to the same site. All injections will be administered in the anterior abdominal wall every 28 days.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Goserelin
Primary outcome measureThe success of hysteroscopic resection in achieving complete removal of fibroid.
Secondary outcome measuresThe length of the operation and associated complications in both treatment and placebo group.
Overall study start date01/10/2005
Completion date01/10/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants120
Key inclusion criteria1. Women with symptomatic submucous fibroids diagnosed on saline infusion hydrosonography
2. Fibroids suitable for hysteroscopic resection
3. Written informed consent obtained
Key exclusion criteria1. Fibroids not suitable for hysteroscopic resection
2. Written informed consent declined
3. Malignant histology discovered on histological analysis
Date of first enrolment01/10/2005
Date of final enrolment01/10/2006

Locations

Countries of recruitment

  • United Kingdom

Study participating centre

King's College Hospital
London
SE 5 8RX
United Kingdom

Sponsor information

Funders

Funder type

Hospital/treatment centre

King's College Hospital NHS Trust (UK)

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
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