ISRCTN48609976进行中（未招募）未知
Recurrence of endometriosis: a randomised controlled trial of clinical and cost-effectiveness of gonadotrophin-releasing hormone analogues with add-back hormone replacement therapy versus repeat laparoscopic surgery (REGAL)
HS Grampian0 个研究点目标入组 400 人开始时间: 2021年11月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •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
排除标准
- •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)
研究者
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