Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Submucous 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
Not provided at time of registration
Study design
Randomised double blind placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Submucous fibroids
Intervention
This 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 type
Drug
Phase
Not Specified
Drug names
Goserelin
Primary outcome measures
The success of hysteroscopic resection in achieving complete removal of fibroid.
Secondary outcome measures
The length of the operation and associated complications in both treatment and placebo group.
Overall trial start date
01/10/2005
Overall trial end date
01/10/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Women with symptomatic submucous fibroids diagnosed on saline infusion hydrosonography
2. Fibroids suitable for hysteroscopic resection
3. Written informed consent obtained
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
120
Participant exclusion criteria
1. Fibroids not suitable for hysteroscopic resection
2. Written informed consent declined
3. Malignant histology discovered on histological analysis
Recruitment start date
01/10/2005
Recruitment end date
01/10/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
King's College Hospital
London
SE 5 8RX
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
King's College Hospital NHS Trust (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
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20663795
Publication citations
-
Results
Mavrelos D, Ben-Nagi J, Davies A, Lee C, Salim R, Jurkovic D, The value of pre-operative treatment with GnRH analogues in women with submucous fibroids: a double-blind, placebo-controlled randomized trial., Hum. Reprod., 2010, 25, 9, 2264-2269, doi: 10.1093/humrep/deq188.