E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Proliferation of the endometrium. |
|
E.1.1.1 | Medical condition in easily understood language |
Prevention of endometrial cancer and pre-cancer in women with a high BMI. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine whether the Mirena coil is effective at interrupting pathways in the womb associated with increased risk of developing cancer. |
|
E.2.2 | Secondary objectives of the trial |
1) To assess if the Mirena IUS is acceptable to women as a preventative treatment for endometrial cancer. 2) To assess the effects the Mirena IUS on physical and mental wellbeing. 3) To see what effects (if any) the Mirena IUS has on hormone levels in the blood in obese women
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1 Women seen in the Sleep Apnoea Clinic at Salford Royal Hospital 2 BMI >40 3 Informed consent 4 Aged 18 or over 5 Normal up to date smear 6 Normal endometrial sample at screening
|
|
E.4 | Principal exclusion criteria |
1) Previous hysterectomy 2) LNG-IUS or IUD in situ or in previous 6 months 3) Pregnant or breast feeding 4) Previous endometrial ablation 5) Breast cancer 6) Congenital/acquired uterine anomaly 7) Pelvic inflammatory disease, current STI or genital actinomycosis 8) Immunodeficiency 9) Progestin IUS contraindicated (coagulopathy, liver disease, migraine, raised blood pressure, arterial disease)
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
1) Ki 67 expression in the endometrium (a marker of proliferation).
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Serial endometrial biopsies and fasting study bloods will be taken at the screening appointment, at Mirena insertion and 6-9 months following Mirena insertion. The questionnaire will be completed at the screening appointment and at the 9-12 month follow-up appointment. |
|
E.5.2 | Secondary end point(s) |
3) Endocrine markers including but not limited to: a. Fasting serum glucose & insulin, HbA1c, IGFBP-1 and C-peptide levels b. SHBG, oestrogen, progesterone, free androgen index, FSH, LH, testosterone, CRP c. Leptin, adiponectin 4) Changes in menstrual function, physical and mental wellbeing
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
We will take a detailed medical and gynaecological history, including a history of menstrual abnormalities, hormonal and contraceptive use and baseline observations at all three appointments (screening, Mirena insertion and 6-9 month follow up). |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The 12 month follow up of the last patient taking part in the study. A further 9 months will be needed for investigational work and writing up the results for publication. N.B we may offer extended follow up at the 12 month appointment for annual biopsy and review up to 5 years, after substantial amendment agreement by the REC. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |