Endometriosis MedDRA version: 14.1 Level: PT Classification code 10014778 Term: Endometriosis System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Trade Name: Mirena®
Product Name: Levonorgestrel releasing intra-uterine system
Pharmaceutical Form: Intrauterine delivery system
INN or Proposed INN: Levonorgestrel
CAS Number: 797-63-7
Concentration
Sponsors
University of Aberdeen & NHS Grampian
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Investigators will be asked to confirm each eligibility criteria at randomisation. Inclusion Criteria: To be eligible for the PREEMPT Trial: • Women aged 16-45 • No immediate plans to conceive • Are scheduled to have laparoscopic conservative surgery, or a diagnostic laparoscopy with concurrent surgery if endometriosis is found, for pelvic pain associated with endometriosis. • (Pilot phase) willing to be randomised to at least one long acting progestogen (LNG-IUS/ DMPA) and either COCP or no treatment Are the trial subjects under 18? yes 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 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Any women, who at the point of randomisation, have any of the following are not eligible for the trial: • Current infertility (trying for a baby, receiving or contemplating fertility treatment) • Deep infiltrating endometriosis, involving the bowel or rectovaginal septum, and requiring complex surgery, whether pre-planned or identified at laparoscopy • Contraindications to the use of hormonal treatment with oestrogen or progestogens • Suspicion of malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main study principal objective To compare, in women undergoing conservative surgery for pain due to endometriosis, the effectiveness of some or all of the following four post-surgical treatment options in controlling the recurrence of symptoms and improving quality of life: 1) no treatment 2) levonorgestrel-releasing intra-uterine System (LNG IUS) 3) three monthly depot medroxyprogesterone acetate injections (DMPA) 4) the combined oral contraceptive pill (COC), dependent on the groups carried forward from the pilot.;Secondary Objective: Pilot study objectives: • To ascertain if randomising to one or more of the four treatment options will prove a barrier to overall recruitment, assess if a four-way randomisation is feasible and refine the research question. • To pilot and fine-tune study procedures, data capture forms and the assumptions around the sample size estimation • To understand which factors motivate women to agree to be randomised for follow up treatment following surgery for endometriosis • To explore barriers to recruitment to the trial Secondary clinical objectives: • To compare all four interventions in terms of pain relief, side-effects, acceptability, repeat surgery, recurrence of endometriotic ovarian cysts. Economic: • To compare the relative cost effectiveness of alternative hormonal interventions, DMPA injection, LNG-IUS,and combined contraceptive, to no hormonal treatment for the prevention of recurrent endometriosis. The main comparator will be no treatment but as with all decision a;Primary end point(s): The primary outcome is the recurrence of symptoms as evaluated by the pain domain of the EHP-30 questionnaire at 36 months post-randomisation. The EHP-30 is a disease specific questionnaire to measure the health status of women with endometriosis. It demonstrates good reliability, validity, acceptability and responsiveness,with low floor and ceiling effects for the core questions. EHP-30 contains 30 core items with 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): CLINICALEHP-30 The remaining four core domains of the EHP-30 (control, emotional aspects, social support and self-image) and the six modular domains (work, relationship with family, sexual intercourse, medical professions, treatment, infertility), where completed, will be compared between groups. Pain scores will be collected using visual analogue scales. Fatigue, as measured by Fatigue Severity Score (FSS) Use of dietary supplements, following a gluten free or otherwise restrictive diet, or are using complementary therapies such as acupuncture. Generic health related quality of life (EQ-5D) and capabilities (ICECAP-A);Timepoint(s) of evaluation of this end point: Participant reported outcomes will be collected prior to randomisation and at 6, 12, 24 and 36 months post-randomisation. | — |
Countries
United Kingdom
Contacts
Public ContactDr Gail Holland
University of Aberdeen & NHS Grampian
Outcome results
None listed