Endometrial cancer/tumours in women with Hereditary Non-polyposis Colorectal Cancer (HNPCC) MedDRA version: 9.1 Level: LLT Classification code 10051981 Term: Lynch syndrome
Conditions
Interventions
Trade Name: Mirena
Product Name: Mirena
Pharmaceutical Form: Intrauterine delivery system
INN or Proposed INN: Levonorgestrel
Concentration unit: mg milligram(s)
Concentration type: equal
Concentratio
Sponsors
St George's, University of London (SGUL)
Queen Mary and Westfield College, University of London (QMUL)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women with HNPCC, intact uterus, aged of 30-65y. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnant not HNPCC Affected with endometrial cancer Outside age range
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the efficacy of the Mirena IUS to reduce atypical endometrial hyperplasia and endometrial cancer in women with HNPCC, who have a lifetime risk of up to 60% of developing endometrial cancer.;Primary end point(s): Detection of atypical endometrial hyperplasia or cancer;Secondary Objective: Assess the patient acceptability and psychological effects of the Mirena IUS in this context . Also assess the efficacy of surveillance to detect endometrial hyperplasia and cancer using transvaginal ultrasound and endometrial biopsy, and the natural history of endometrial hyperplasia-neoplasia in women with HNPCC. Also assess the possible adverse effects of this treatment. | — |
Countries
United Kingdom
Outcome results
None listed