EUCTR2013-005494-53-GB进行中（未招募）不适用
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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •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
- •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
排除标准
- •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.
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