EUCTR2012-000036-26-IT进行中（未招募）不适用
: A Phase III, multicentre, randomized, double-blind clinical study, investigating the efficacy and safety of repeated 12-week courses of daily 5mg or 10mg doses of PGL4001 for the long-term management of symptomatic uterine fibroids. - PEARL IV
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- PREGLEM SA
- 入组人数
- 437
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.Subject with hormonal levels FSH = 20 mIU/mL (measured at screening 2 visit). 5.Subject with myomatous uterus < 16 weeks (compared to a uterus of 16 weeks of pregnancy) 6.Subject with a largest uterine myoma between 3 cm and 12 cm diameter inclusive. 7.Subject with menstrual cycle =22 and =35 days. The menstrual cycle between screening 1 visit and visit 2 should be the one considered for assessing eligibility. 8.PBAC score >100 as measured during screening over the first 8 days of the menstrual bleed. 9.Subject has no significant findings at breast examination at the screening visit. 10.Females of childbearing potential are advised to practice a non-hormonal method of contraception among one of the following:Sexual abstinence, Diaphragm, Condom, having a partner with a vasectomy with either confirmed azoospermia or performed at least 6 months prior to the study. Females of non-childbearing potential are defined as women with tubal ligation sterilisation at least two months before the start.
- •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 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.history of uterus surgery that would interfere with the study endpoints. 2. history of or current uterus, cervix, ovarian or breast cancer. 3.significant and persisting finding on Papanikolaou test (PAP) smear within the past 12 months. 4. history of endometrium hyperplasia or adenocarcinoma or similar lesions in the screening biopsy. 5. large uterine polyp (> 2cm). 6. calcified myomas and/or calcified uterus. 7. known severe coagulation disorder. 8. one or more ovarian cysts = 4cm diagnosed by ultrasound. 9. history of treatment for myoma with a SPRM. 10. The subject has been taking prohibited medication : Treatments with progestins or an oral contraceptive within the month before the screening visit; Acetylsalicylic acid; mefenamic acid; anticoagulants and/or antifibrinolytic drugs within one week before the screening visit; Systemic glucocorticoid treatments and/or systemic depot glucocorticoid treatments within one week or two months before the screening visit, respectively; GnRH agonist and antagonist: 11.The subject is likely to require treatment during the study with drugs that are not permitted by the study protocol: progestins hormonal contraceptives, systemic glucocorticoids, GnRH agonist and GnRH antagonists. 12. treatment with a medication which includes potent inhibitors of CYP3A4 13.treatment with a medication which includes potent inducers of CYP3A4. 14.The subject requires treatment with a medication which includes P-gp substrates. 15.The subject has abnormal hepatic function at study entry 16. positive pregnancy test at baseline, is nursing or planning a pregnancy during the course of the study. 17. problem with alcohol or drug abuse. 18. mental condition rendering her unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude. 19.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. 20. allergy to SPRMs or progestins or any of the ingredients of the study drug tablet 21.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.
研究者
相似试验
尚未招募
3 期
A Phase III Study to Investigate Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin in Participants with Chronic Kidney Disease and High Proteinuria (ZENITH High Proteinuria)Chronic Kidney Disease and High ProteinuriaJPRN-jRCT2031230557Ageishi Yuji200
招募中
1 期
A Phase III Study to assess efficacy, safety, and tolerability of Zibotentan combined with Dapagliflozin, compared to Dapagliflozin, in patients with Chronic Kidney Disease and High ProteinuriaChronic Kidney Disease and High ProteinuriaMedDRA version: 21.1Level: PTClassification code: 10064848Term: Chronic kidney disease Class: 100000004857MedDRA version: 20.0Level: SOCClassification code: 10038359Term: Renal and urinary disorders Class: 18CTIS2023-504124-26-00AstraZeneca AB1,500
招募中
3 期
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (TILIA).CTRI/2023/09/058035AstraZeneca Pharma India Ltd
招募中
1 期
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (TILIA).Severe viral lung infectionsMedDRA version: 21.1Level: PTClassification code 10001053Term: Acute respiratory failureSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2022-003107-15-DKAstraZeneca AB2,902
进行中（未招募）
1 期
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (TILIA).Severe viral lung infectionsMedDRA version: 21.1Level: PTClassification code 10001053Term: Acute respiratory failureSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2022-003107-15-BEAstraZeneca AB2,902