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The objective is to evaluate the efficacy and safety of TAK-385 40 mg orally administrated once daily for 24 weeks compared with Leuprorelin [once/4 weeks, 3.75 or 1.88 mg subcutaneously (SC)/time] in patients with endometriosis.
This study is a phase III, multicenter, randomized, double-blind, parallel-group study to investigate the efficacy and safety of TAK-385 40 mg once daily compared with leuprorelin (once/4 weeks, 3.75 or 1.88 mg SC/time) in premenopausal subjects ≥ 20 years of age with endometriosis. 320 women with endometriosis will be enrolled in the study. This study consists of screening of approximately 1 to 6 weeks, run-in of approximately 3 to 6 weeks, treatment of 24 weeks, and follow-up of 4 weeks. After signing the informed consent form, subjects should record their symptoms in the electronic patient diary every day. During run-in period, daily data will be collected in the electronic patient diary for calculation of the baseline values for the efficacy evaluation.Following run-in period, subjects will receive investigational products (TAK-385 + leuprorelin placebo or TAK-385 placebo + leuprorelin) under double blind. During this study, subjects will visit the study center to undergo the designated examinations and evaluations at each visit. Safety will be assessed throughout the study by monitoring adverse events, vital signs, physical examinations, clinical laboratory tests, 12-lead electrocardiograms (ECG), and assessments of bone mineral density.Subjects will visit the study center to undergo the designated examinations and evaluations at 28 days after final administration.
TAK-385, Leuprorelin acetate
Chubu Rosai Hospital
Not yet recruiting
ASKA Pharmaceutical Co., Ltd.
Published on BioPortfolio: 2019-05-05T16:45:34-0400
The purpose of this study is to evaluate the efficacy, safety, and dose-response relationship of KLH-2109 compared to placebo in Japanese patients with endometriosis.
This study is designed to evaluate the safety and beneficial effects of NBI-56418 compared to placebo and leuprorelin (an approved endometriosis therapy) over a three month period followed...
The study consists of the generation of biological samples (in urine) positive to leuprorelin acetate for doping control by new developed methods, and establish the analytical parameters t...
The purpose of this survey is to evaluate the long-term safety and efficacy of leuprorelin acetate injection kit 11.25 mg in patients with spinal and bulbar muscular atrophy (SBMA) in the ...
This is a Phase IIIb, multicentric, national, randomised, double blind. Patients are included at visit V0 (the start of treatment with leuprorelin). At the end of the 6th month (visit 1)...
Studies have shown that the N-terminus and lysine side residue of peptides are prone to acylation in poly(D,L-lactide-co-glycolide) (PLGA) microspheres. Peptides such as leuprorelin lack a free N-term...
Endometriosis and quality of life has been the subject of much research, however, there is little consensus on how best to evaluate quality of life in endometriosis, resulting in many and diverse scal...
To evaluate appendiceal endometriosis (AE) prevalence and risk factors in endometriotic patients submitted to surgery.
Endometriosis, characterized by the presence of extra-uterine endometrium, is a common gynecologic disorder in reproductive-age women. Although the detailed molecular mechanism of etiology remains une...
We are pleased to read the recent letter to editor by Barra and Ferrero who have been interested in our recent publication in AOGS. In that report, we demonstrated the decreased expression of Tensin 1...
An enzyme that catalyzes the conversion of acetate esters and water to alcohols and acetate. EC 188.8.131.52.
Megestrol acetate is a progestogen with actions and uses similar to those of the progestogens in general. It also has anti-androgenic properties. It is given by mouth in the palliative treatment or as an adjunct to other therapy in endometrial carcinoma and in breast cancer. Megestrol acetate has been approved to treat anorexia and cachexia. (From Reynolds JEF(Ed): Martindale: The Extra Pharmacopoeia (electronic version). Micromedex, Inc, Englewood, CO, 1995)
A 6-methyl PROGESTERONE acetate with reported glucocorticoid activity and effect on ESTRUS.
An enzyme that catalyzes the formation of CoA derivatives from ATP, acetate, and CoA to form AMP, pyrophosphate, and acetyl CoA. It acts also on propionates and acrylates. EC 184.108.40.206.
An enzyme that catalyzes reversibly the phosphorylation of acetate in the presence of a divalent cation and ATP with the formation of acetylphosphate and ADP. It is important in the glycolysis process. EC 220.127.116.11.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...