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). - Changes in Histology following Ulipristal Therapy in Endometriosis 1.1

Overview

No summary available.

Registry

who.int

Start Date

September 8, 2014

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•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)
•d. non\-hormonal intra\-uterine device
•e. abstinence

•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: