Endometriosis MedDRA version: 17.0 Level: PT Classification code 10057902 Term: Endometriosis ablation System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 17.0 Level: LLT Classification code 10014785 Term: Endometriosis of pelvic peritoneum System Organ Class: 10038604 - Reproductive system and breast disorders MedDRA version: 17.0 Level: LLT Classification code 10014788 Term: Endometriosis related pain System Organ Class: 10038604 - Reproductive system and breast d
Conditions
Interventions
Trade Name: Esmya
Product Name: Ulipristal Acetate (Esmya)
Pharmaceutical Form: Tablet
INN or Proposed INN: Ulipristal (INN) Acetate
CAS Number: 126784-99-4
Current Sponsor code: PGL4001
Other descrip
Sponsors
Norfolk and Norwich University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent prior to any study related procedures. 2. Pre-menopausal women between 18 and 50 years inclusive. 3. Subject with a Body Mass Index =18 and =40. 4. Regular menstrual pattern with cycle length 22-35 days. 5. Surgically (laparoscopic) diagnosed endometriosis requiring further surgical treatment. 6. If sexually active, agrees to use of adequate non-hormonal contraceptive method(s) to prevent pregnancy for duration of study and 12 weeks after the last dose: a. subject has undergone surgical sterilisation b. subjects partner has undergone surgical sterilisation (>12 weeks before consent signed) c. condoms d. non-hormonal intra-uterine device e. abstinence 7. No abnormality on screening breast examination. 8. Subject is willing to take part in study and understands definitive surgery will be delayed until course of Ulipristal acetate is completed. Are the trial subjects under 18? no 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 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. The subject has a history of or current uterus, cervix, ovarian or breast cancer. 2. The subject has had a significant and persisting finding on cervical screening (liquid based cytology)smear within the past 12 months. 3. The subject has a history of endometrial hyperplasia or abnormalities detected on first endometrial biopsy. 4. Subject has one or more endometrioma = 4cm diagnosed during diagnositic laparoscopy. 5. The subject has a history of treatment for leiomyoma with a SPRM. 6. The subject has been taking prohibited medication: o Treatments with progestins (systemic or progestin releasing intra-uterine system) or an oral contraceptive: within the month before the screening visit. o Acetylsalicylic acid, mefenamic acid, anticoagulants such as cumarins and/or antifibrinolytic drugs such as tranexemic acid within one week before the screening visit o Systemic glucocorticoid treatments and/or systemic depot glucocorticoid treatments within one week or two months before the screening visit, respectively. o GnRH agonist and antagonist: ? Immediate or monthly sustained release depot preparation or immediate release form within 6 months of screening visit ? 3 or 6 months sustained release depot preparation within 12 months before the screening visit. 7. The subject is likely to require treatment during the study with drugs that are not permitted by the study protocol: progestins (systemic or progestin releasing intra-uterine system), hormonal contraceptives, systemic glucocorticoids (oral and injectable), GnRH agonist and GnRH antagonists. 8. The subject requires treatment with a medication which includes potent inhibitors of CYP3A4 (such as ketoconazole) 9. The subject requires treatment with a medication which includes potent inducers of CYP3A4 (such as rifampicin). 10. The subject has abnormal hepatic function at study entry (defined as alanine transaminase [ALT], hepatic alkaline phosphatase, or total bilirubin above twice the upper limit of normal). In case of isolated elevated GGT, the subject may be enrolled if the re-test is within the allowed limits. 11. The subject has a positive pregnancy test at baseline, is nursing or planning a pregnancy during the course of the study. 12. The subject has a problem with alcohol or drug abuse. 13. The subject has a mental condition rendering her unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude. 14. The subject has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject?s safety or interfere with study evaluations. 15. The subject has an allergy to SPRMs or progestins or any of the ingredients of the study drug tablet (Microcrystalline cellulose, Mannitol, Croscarmellose sodium, Talc, Magnesium Stearate (vegetable origin)). 16. The subject is currently enrolled in an investigational drug or device study or participated in such a study within the previous 30 days and is still in exclusion period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the post-treatment histological appearance in ectopic endometrial deposits found in patients with pelvic endometriosis after a course of Ulipristal acetate.;Secondary Objective: To study the change in disease severity (symptomatic and laparoscopic appearance) following treatment with Ulipristal acetate. To correlate any symptom changes with the post treatment histological changes in the ectopic endometrium. To assess the histological changes in the eutopic endometrium following treatment with Ulipristal.;Primary end point(s): As this is an interventional descriptive cohort study the primary outcome data will be qualitative and descriptive. We aim to describe the post-treatment histological appearance in ectopic endometrial deposits found in patients with pelvic endometriosis after a 3 month course of Ulipristal acetate. The histological data for each subject will be described and grouped according to any features found. The data will be presented as text/tables/figures throughout the written text of the study report.;Timepoint(s) of evaluation of this end point: This evaluation will take place at the end of the 3 month treatment course. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes in disease severity will be assessed by comparing the laparoscopic appearance of endometriotic lesions between the diagnostic surgery and the second definitive surgery. These changes will be correlated with any quantitative changes identified in the patient reported outcome questionnaires: • Change from baseline to the End of Treatment (EoT) of the average scores of the Composite Pelvic Signs & Symptoms Score (CPSSS). • Change from baseline to the End of Treatment (EoT) of the average scores of the Endometriosis Health Profile Questionnaire (EHP-30). • Change from baseline to the End of Study of the average scores of the BSGE Pelvic Pain Questionnaire • The average results of the Patients’ Global Impression of Change (PGIC) scale will be reported as a direct measure of patient satisfaction. Changes in the disease severity (patient reported outcomes and laparoscopic appearance) will be correlated with the histology of the ectopic endometrium, if relevant. Any associations will be described and highlighted. The histological appearance and receptor expression of the eutopic endometrium will be described for both pre- and post treatment. The post treatment samples will be analysed separately before undertaking any comparison between pre- and post- treatment samples. In particular, any features consistent with PAEC (progesterone receptor modulator associated endometrial changes) will be highlighted to inform any post-op follow up. ;Timepoint(s) of evaluation of this end point: This evaluation will take place at the end of the 3 month treatment course. | — |
Countries
United Kingdom
Contacts
Public ContactEdward Morris
Norfolk and Norwich University Hospital NHS trust
Outcome results
None listed