Endometriosis Urological and Genital Diseases Endometriosis
Conditions
Interventions
Women who experience recurrence of pain following previous laparoscopic treatment for endometriosis will be invited to take part. Women will be referred by their GP to specialist endometriosis centres
Sponsors
NHS Grampian
University of Aberdeen
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged 21–49 years with recurrent pain following laparoscopic surgery for endometriosis (excision or ablation) who wish to avoid removal of ovaries and hysterectomy, irrespective of site and stage of endometriosis, number of previous surgeries or use of post-operative hormonal treatment. 2. Women who are considered suitable for both treatment arms 3. Able and willing to give informed consent to participate and to participate in study procedures, including DEXA scans (There are provisions within the protocol for recording consent from patients who are not able to read or write (but who have the capacity and who can speak English sufficiently to understand the information being provided orally) 4. Willing to undergo a pregnancy test prior to intervention
Exclusion criteria
Exclusion criteria: 1. Previous diagnostic laparoscopy only (no treatment to endometriosis) 2. Planning to conceive in the next 2 years 3. Current pregnancy or breastfeeding 4. Previous bilateral oophorectomy 5. Current or recent (within the last 3 months) users of GnRHa 6. Contraindicated concomitant medications with GnRHa. These are women currently using hormonal contraceptives who are unwilling to stop their use during the follow-up period (for example, progesterone only pill, combined oral contraceptive pill, depo injection or contraceptive implant); medicinal products that raise prolactin levels (for example domperidone, metoclopramide, haloperidol, risperidone and sulpride); and medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes such as class IA (for example quinidine, disopyramide) or class III (for example amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics). 7. Hypersensitivity to GnRH (gonadotropin-releasing hormone), its analogues or to any of the excipients 8. Women at high risk of serious adverse effects with GnRHa such as a confirmed diagnosis of osteoporosis 9. Women with risk factors for osteoporosis such as chronic alcohol abuse, current heavy smokers over 20 cigarettes per day, long-term therapy with drugs that reduce bone mineral density currently or in the last 3 months, such as anticonvulsants or oral corticosteroids (2.5mg per day), family history of osteoporosis, and malnutrition, e.g. anorexia nervosa 10. Diagnosis of severe depression in the last 10 years. For the purposes of REGAL, severe depression includes but is not limited to suicidal thoughts, requirement for hospitalisation and symptoms that make it almost impossible to get through daily life 11. Contraindications for add-back HRT use: these are women with a personal history of breast cancer, known carriers of BRCA 1 and 2, personal history of venous thromboembolism or women with known inherited thrombophilia (e.g.: Factor V Leiden, Protein C or S or Antithrombin deficiency, Prothrombin gene mutation)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical: Endometriosis-associated pain measured using the pain domain of the condition-specific Endometriosis Health Profile-30 (EHP-30) at 24 months Economic: Incremental cost per QALY gained from a health service perspective, measured using self-completed questionnaires and case note reviews at 24 months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical: 1. Bone mineral density (BMD) measured using Dual Energy X-ray absorptiometry (DEXA) scan for a subgroup of patients (90 women in each arm across a minimum of 5 centres ideally recruited over 18 months). For the GnRHa group BMD will be measured at baseline, 12 and 24 months post-randomisation, for the laparoscopic surgery group at baseline and 24 months post-randomisation 2. Surgical and anaesthetic complications and adverse events assessed using self-completed questionnaires and case note reviews at 24 months post-randomisation Patient-reported (measured using self-completed questionnaires at 6, 12, 18 and 24-months post-randomisation unless stated otherwise): 1. Adverse events that are a result of treatment for endometriosis 2. Endometriosis treatment received 3. Generic and condition-specific quality of life, measured using EQ-5D and EHP-30 at baseline, 6, 12, 18 and 24 months post-randomisation 4. Endometriosis-associated pain measured using the pain domain of EHP-30 at 6, 12, and 18 months 5. Patient satisfaction measured on a six-point scale from ‘totally satisfied’ to ‘totally dissatisfied’ 6. Further pharmacological treatment (change of hormonal treatment, increased use of analgesics, start of neuromodulators such as pregabalin, gabapentin, amitryptiline) or surgery for endometriosis or other treatments (e.g. acupuncture, CBT) for endometriosis-associated pain 7. Pregnancy | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed