Trial to investigate the effects of the use of pre-operative GnRH analogue and intra-operative mechanical tourniquet for myomectomy on surgical blood loss, future fertility and quality of life.

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]; terine Fiboids; MedDRA version: 20.0 Level: LLT Classification code 10046784 Term: Uterine fibroids System Organ Class: 100000004864

• Registration Number: EUCTR2010-019810-26-GB
• Lead Sponsor: King's College Hospital Foundtion NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-07
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

Informed consent to participate
Diagnosis of uterine fibroids via ultrasonography and considered suitable for myomectomy by a consultant gynaecologist
Females between Age 18-50
Uterine size 14 weeks or more and/or uterine volume 600 cm3 or more
Willing to take adequate contraception

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Patient refusal
Age over 50 or under 18
Uterine size 12 weeks or less and/or uterine volume 500 cm3 or less
Previous Myomectomy
Patient Suitable for vaginal or endoscopic myomectomy
Women of child bearing potential not willing to take adequate contraception Participants will have a pregnancy test prior to IMP administration.
Patients who in the opinion of the Investigator would not be a suitable candidate for study participation.
Post menopausal women
Any contraindications for Prostap use including the following:
• Diabetic patients at risk of bone density loss or who are poorly controlled – Well controlled Diabetics may be included however the investigating team will need confirmation of adequate diabetic control from their endocrine physician
• Clinically Significant Hepatic dysfunction
• Patients with hypotension should only be included if condition is well controlled (extra observations should be implemented in form of BP measurements at each visit)
• Patients with depression
• Patients at high risk of bone density loss (risk factors include alcohol/smoking/family history) may be included if it is felt by the chief investigator that the benefits of the 3 doses of Prostap outweigh any risk to the patient

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the clinical efficacy and cost-effectiveness of pre-operative use of GnRH analogues and intra-operative use of mechanical tourniquet in reducing intra-operative blood loss;Secondary Objective: ;Primary end point(s): Mean blood loss. ;Timepoint(s) of evaluation of this end point: During operation via absorbtion to special drapes, collection of blood into cell saver aperatus and post-op bloos tests.