A Study of the Histological Changes within Ectopic Endometrial Tissue, in Subjects with Pelvic Endometriosis- Following Treatment with Ulipristal Acetate, a Selective Progesterone Receptor Modulator (SPRM).

• Conditions: Endometriosis; MedDRA version: 17.0Level: PTClassification code 10057902Term: Endometriosis ablationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 17.0Level: LLTClassification code 10014785Term: Endometriosis of pelvic peritoneumSystem Organ Class: 10038604 - Reproductive system and breast disorders; MedDRA version: 17.0Level: LLTClassification code 10014788Term: Endometriosis related painSystem Organ Class: 10038604 - Reproductive system and breast disorders; MedDRA version: 17.0Level: LLTClassification code 10014779Term: Endometriosis in pelvis, excisionSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 17.0Level: PTClassification code 10014778Term: EndometriosisSystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2013-005494-53-GB
• Lead Sponsor: orfolk and Norwich University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-08
• Last Update Posted: 30 March 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified