Changes in Histology following Ulipristal Therapy in Endometriosis 1.1
Research type
Research Study
Full title
A Study of the Histopathological Changes within Ectopic Endometrial Tissue, in Subjects with Known Pelvic Endometriosis Following Treatment with Ulipristal Acetate, a Selective Progesterone Receptor Modulator (SPRM).
IRAS ID
137405
Contact name
Edward Morris
Contact email
Sponsor organisation
Norfolk and Norwich University Hospitals NHS Foundation Trust
Eudract number
2013-005494-53
Research summary
Endometriosis is common disease, affecting 10% of women of reproductive age. The clinical symptoms are painful menstruation, persistent pelvic pain, pain during intercourse and infertility. Pharmacological agents play an important role in control of symptoms as well as disease suppression, especially in young women who wish to retain their fertility. This currently involves non-steroidal anti inflammatory drugs (NSAIDs) or hormonal agents, such as progestogens or gonadotrophin releasing hormone (GnRH) analogues. Systemic side effects limit the effective use of many hormonal agents.
Ulipristal acetate is a selective progesterone receptor modulator that acts mainly on the progesterone receptors of the reproductive tract. It has recently been introduced to clinical practice as a pre-operative treatment of fibroids. Studies have demonstrated histological changes in the endometrial lining of the uterus after treatment with Ulipristal. However, whether similar changes occur in the ectopic endometrium in pelvic endometriois is not clear. If such changes are seen, Ulipristal may form the basis of a new treatment modality.The study aims to assess the changes in the ectopic endometrial deposits of patients with pelvic endometriosis, after a three month treatment course of Ulipristal acetate. In particular, post treatment histological changes will be described and then correlated with changes in the macroscopic appearance of the disease and symptom severity.
Patients with endometriosis will have already been diagnosed and staged at diagnostic laparoscopy prior to recruitment. In patients requiring further surgical treatment consent will be obtained for a three month course of daily Ulipristal acetate, prior to any planned surgery. No other modification to the clinical management will be made. At the repeat laparoscopy the disease will be re-classified and samples obtained for histological analysis of both the ectopic deposits and the eutopic endometrium. The study will be carried out over a period of one year until 20 subjects are recruited.
REC name
HSC REC A
REC reference
14/NI/1050
Date of REC Opinion
11 Aug 2014
REC opinion
Further Information Favourable Opinion