TAK-385

DRUG7 trials

Sponsors

Takeda, Millennium Pharmaceuticals, Inc., ASKA Pharmaceutical Co., Ltd.

Conditions

EndometriosisHormone Treatment-naïve Participants With Prostate CancerProstate CancerUterine Fibroids

Phase 1

A Phase 1 Study to Evaluate the Effects of Fluconazole and Atorvastatin on the Pharmacokinetics of TAK-385 in Healthy Subjects

CompletedNCT02093390

Millennium Pharmaceuticals, Inc.Endometriosis, Prostate Cancer

Start: 2014-03-31End: 2014-04-30Updated: 2016-06-06

A Study of TAK-385 in Hormone Treatment-naïve Participants With Prostate Cancer

CompletedNCT02141659

TakedaHormone Treatment-naïve Participants With Prostate Cancer

Start: 2014-05-01End: 2017-04-20Updated: 2018-11-19

Phase 2

Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids

CompletedNCT01452659

TakedaUterine Fibroids

Start: 2011-10-31End: 2012-09-30Updated: 2013-01-21

A Long-term Extension Study of TAK-385 in the Treatment of Endometriosis

CompletedNCT01452685

TakedaEndometriosis

Start: 2012-03-31End: 2013-12-31Updated: 2014-05-08

Efficacy and Safety of TAK-385 in the Treatment of Endometriosis

CompletedNCT01458301

TakedaEndometriosis

Start: 2011-10-31End: 2013-08-31Updated: 2014-02-25

Safety and Efficacy of TAK-385 for Patients With Localized Prostate Cancer

CompletedNCT02135445

Millennium Pharmaceuticals, Inc.Prostate Cancer

Start: 2014-06-30End: 2015-12-31Updated: 2017-04-13

Phase 3

Clinical Study to Evaluate Efficacy and Safety of TAK-385 40 mg Compared With Leuprorelin in Patients With Endometriosis

CompletedNCT03931915

ASKA Pharmaceutical Co., Ltd.Endometriosis

Start: 2019-05-08End: 2020-09-28Updated: 2020-12-11

Related Papers

Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, reduces endometriosis-associated pain compared with leuprorelin in Japanese women: a phase 3, randomized, double-blind, noninferiority study.

2021-12-0839 citations

Relugolix for oral treatment of uterine leiomyomas: a dose-finding, randomized, controlled trial

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Relugolix, an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, in women with endometriosis-associated pain: phase 2 safety and efficacy 24-week results

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Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, reduces endometriosis-associated pain in a dose-response manner: a randomized, double-blind, placebo-controlled study.

2020-09-0760 citations

Phase I trial of TAK‐385 in hormone treatment‐naïve Japanese patients with nonmetastatic prostate cancer

Cancer Medicine2019-08-1931 citations

PD28-01 TESTOSTERONE LOWERING, PSA RESPONSE AND QUALITY OF LIFE IN PATIENTS WITH ADVANCED HORMONE SENSITIVE PROSTATE CANCER RECEIVING TAK-385, AN ORAL GNRH ANTAGONIST: PHASE 2 INTERIM ANALYSIS

The Journal of Urology2016-03-284 citations