Title: Relugolix with oestradiol and norethisterone acetate for treating uterine fibroids (ID3842)
Funder: Department of Health and Social Care

Abstract: Uterine fibroids are noncancerous growths of the uterus. The exact cause of fibroids is not known, but they have been linked to the hormone oestrogen.[1] Most are asymptomatic, but they can cause significant morbidity. The most common symptom of uterine fibroids is heavier than normal or prolonged menstrual bleeding. Other symptoms include pelvic pressure or pain, frequent urination, constipation and pain or discomfort during sex. In rare cases, complications with fibroids can interfere with pregnancy or cause infertility.[1] The type and severity of symptoms is influenced by the location, size and number of fibroids.[2] Fibroids are generally classified by their location. Intramural fibroids grow within the muscular uterine wall. Submucosal fibroids grow in the muscle layer beneath the uterus’s inner lining and grow into the uterine cavity. Subserosal fibroids develop outside of the uterus and grow into the pelvis._x000D_ _x000D_ Fibroids usually develop during the reproductive years (from around 16 to 50 years) when oestrogen levels are at their highest.[1] The prevalence of symptomatic fibroids is low in women younger than 30 years but is between 20 to 50% in women older than 30 years.[3] Risk factors for uterine fibroids include race, family history of fibroids, age and obesity.[4]_x000D_ _x000D_ Oestrogen and progesterone control the proliferation and maintenance of uterine fibroids. Most medical treatments act by interfering with their production or function.[4]_x000D_ _x000D_ For people with uterine fibroids less than 3 cm in diameter and not causing distortion of the uterine cavity, NICE guideline 88 (NG88) recommends considering a levonorgestrel-releasing intrauterine system (LNG-IUS) for the treatment of heavy menstrual bleeding. If heavy menstrual bleeding worsens or an LNG-IUS is not suitable, pharmacological treatments (such as tranexamic acid and non-steroidal anti-inflammatory drugs) and hormonal treatments (such as combined hormonal contraception, cyclical oral progestogens and gonadotrophin-releasing hormone analogues) are recommended. Surgery (second-generation endometrial ablation or hysterectomy) is recommended as an option if treatment is unsuccessful or declined, or symptoms are severe. For people with submucosal uterine fibroids less than 3 cm in diameter hysteroscopic removal should be considered. For people with uterine fibroids of 3 cm or more in diameter, the same pharmacological and surgical treatments are recommended as options as well as uterine artery embolisation and myomectomy. Pretreatment with a gonadotrophin-releasing hormone analogue before hysterectomy and myomectomy should be considered if uterine fibroids are causing an enlarged or distorted uterus._x000D_ _x000D_ References_x000D_ 1. NHS. Fibroids. Accessed April 2021 ._x000D_ 2. Mayo Clinic. Uterine fibroids: symptoms and causes. Accessed April 2021._x000D_ 3. BMJ Best Practice: uterine fibroids. Accessed April 2021._x000D_ 4. Lumsden M.A.; Fibroids: diagnosis and management; BMJ; 351:h4887; 2015

Lay abstract: To appraise the clinical and cost effectiveness of relugolix with oestradiol and norethindrone acetate within its marketing authorisation for treating uterine fibroids.

Research activity codes: 6.1 PHARMACEUTICALS
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH