Condition category
Urological and Genital Diseases
Date applied
23/08/2005
Date assigned
30/11/2005
Last edited
15/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Davor Jurkovic

ORCID ID

Contact details

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

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

Sponsor information

Organisation

King's College Hospital (UK)

Sponsor details

Denmark Hill
London
SE5 8RX
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

  1. 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.

Additional files

Editorial Notes