Uterine Fiboids MedDRA version: 20.0 Level: LLT Classification code 10046784 Term: Uterine fibroids System Organ Class: 100000004864
Conditions
Interventions
Trade Name: PROSTAP® SR DCS
Pharmaceutical Form: Powder and solvent for suspension for injection in pre-filled syringe
INN or Proposed INN: LEUPRORELIN ACETATE
Sponsors
King's College Hospital Foundtion NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Contacts
Public ContactDr Nitish Narvekar
Kings College Hospital Foundation NHS Trust
Outcome results
None listed