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Showing 25–48 of 24 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: TAK-385 Clear all
Completed Phase 3 Interventional Results available

LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

NCT03049735
View directory record Official record
Conditions
Heavy Menstrual Bleeding, Uterine Fibroid
Interventions
Relugolix, Estradiol/norethindrone acetate, Estradiol/norethindrone acetate placebo, Relugolix placebo
Drug
Lead sponsor
Myovant Sciences GmbH
Industry
Eligibility
18 Years to 50 Years · Female only
Enrollment
388 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2020
U.S. locations
76
States / cities
Andalusia, Alabama • Mobile, Alabama • Little Rock, Arkansas + 62 more
Source: ClinicalTrials.gov public record
Updated Apr 18, 2022 · Synced Sep 24, 2026, 2:48 AM EDT
Recruiting Phase 2 Interventional

Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer

NCT06059118
View directory record Official record
Conditions
Prostate Cancer
Interventions
DFMO, testosterone cypionate, Luteinizing hormone-releasing hormone (LHRH) analogue, Enzalutamide
Drug
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Other
Eligibility
18 Years and older · Male only
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2029
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Jan 13, 2026 · Synced Sep 24, 2026, 2:48 AM EDT
Recruiting Phase 1 Interventional

Relugolix + Enzalutamide Study in High-Risk Prostate Cancer

NCT06130995
View directory record Official record
Conditions
Androgen Deprivation Therapy, Locally Advanced Prostate Cancer
Interventions
Relugolix and Enzalutamide
Drug
Lead sponsor
University of Oklahoma
Other
Eligibility
18 Years and older · Male only
Enrollment
46 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2030
U.S. locations
1
States / cities
Oklahoma City, Oklahoma
Source: ClinicalTrials.gov public record
Updated Mar 4, 2026 · Synced Sep 24, 2026, 2:48 AM EDT
Completed No phase listed Observational Results available

Description of Relugolix Use in Patients With Prostate Cancer Within the VHA

NCT06462014
View directory record Official record
Conditions
Prostate Cancer
Interventions
Relugolix
Drug
Lead sponsor
Pfizer
Industry
Eligibility
18 Years and older · Male only
Enrollment
507 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Dec 10, 2025 · Synced Sep 24, 2026, 2:48 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study of the Effects of Erythromycin on the Pharmacokinetics of Relugolix, Estradiol, and Norethindrone in Healthy Postmenopausal Women and on the Pharmacokinetics of Relugolix in Healthy Adult Men

NCT04714554
View directory record Official record
Conditions
Healthy
Interventions
Relugolix/E2/NETA FDC, Relugolix, Erythromycin
Drug
Lead sponsor
Myovant Sciences GmbH
Industry
Eligibility
18 Years to 65 Years
Enrollment
43 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021
U.S. locations
1
States / cities
Hialeah, Florida
Source: ClinicalTrials.gov public record
Updated Aug 31, 2021 · Synced Sep 24, 2026, 2:48 AM EDT
Completed Phase 3 Interventional Results available

LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

NCT03103087
View directory record Official record
Conditions
Heavy Menstrual Bleeding, Uterine Fibroid
Interventions
Relugolix, Estradiol/norethindrone acetate, Relugolix placebo, Estradiol/norethindrone acetate placebo
Drug
Lead sponsor
Myovant Sciences GmbH
Industry
Eligibility
18 Years to 50 Years · Female only
Enrollment
382 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2020
U.S. locations
89
States / cities
Birmingham, Alabama • Mesa, Arizona • Tucson, Arizona + 78 more
Source: ClinicalTrials.gov public record
Updated Apr 19, 2022 · Synced Sep 24, 2026, 2:48 AM EDT
Completed Phase 2 Interventional Results available

A Phase 2 Study to Evaluate the Safety and Efficacy of TAK-385, Together With a Leuprorelin Observational Cohort, in Participants With Prostate Cancer

NCT02083185
View directory record Official record
Conditions
Prostate Cancer
Interventions
Relugolix, Leuprorelin
Drug
Lead sponsor
Millennium Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older · Male only
Enrollment
136 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2017
U.S. locations
19
States / cities
Birmingham, Alabama • San Diego, California • Denver, Colorado + 16 more
Source: ClinicalTrials.gov public record
Updated May 8, 2018 · Synced Sep 24, 2026, 2:48 AM EDT
Recruiting Phase 2 Interventional

Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response

NCT07142551
View directory record Official record
Conditions
Metastatic Castration-resistant Prostate Cancer
Interventions
Testosterone cypionate, Luteinizing hormone-releasing hormone (LHRH) analogue, Darolutamide
Drug
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Other
Eligibility
18 Years and older · Male only
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2034
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Mar 10, 2026 · Synced Sep 24, 2026, 2:48 AM EDT
Completed Phase 3 Interventional Results available

Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy

NCT04756037
View directory record Official record
Conditions
Contraception
Interventions
Relugolix Combination Therapy
Drug
Lead sponsor
Sumitomo Pharma Switzerland GmbH
Industry
Eligibility
18 Years to 50 Years · Female only
Enrollment
1,164 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2026
U.S. locations
109
States / cities
Mobile, Alabama • Chandler, Arizona • Mesa, Arizona + 89 more
Source: ClinicalTrials.gov public record
Updated May 12, 2026 · Synced Sep 24, 2026, 2:48 AM EDT
Recruiting Phase 4 Interventional Accepts healthy volunteers

Insights in Endocervical Mucus Secretion

NCT07111247
View directory record Official record
Conditions
Cervical Mucus
Interventions
Gonadotropin Releasing Hormone Antagonists Relugolix
Drug
Lead sponsor
Oregon Health and Science University
Other
Eligibility
21 Years to 40 Years · Female only
Enrollment
15 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2026 – 2027
U.S. locations
1
States / cities
Portland, Oregon
Source: ClinicalTrials.gov public record
Updated Jan 7, 2026 · Synced Sep 24, 2026, 2:48 AM EDT
Withdrawn Phase 4 Interventional Accepts healthy volunteers

Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial (SOUL)

NCT05538689
View directory record Official record
Conditions
Metrorrhagia, Pelvic Pain, Menorrhagia, Leiomyoma
Interventions
Myfembree Oral Product
Drug
Lead sponsor
University of Chicago
Other
Eligibility
18 Years and older · Female only
Healthy volunteers
Accepts healthy volunteers
Timeline
2022 – 2024
U.S. locations
6
States / cities
Chicago, Illinois • Flossmoor, Illinois • Orland Park, Illinois + 1 more
Source: ClinicalTrials.gov public record
Updated Jun 4, 2026 · Synced Sep 24, 2026, 2:48 AM EDT
Active, not recruiting Phase 2 Interventional

Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)

NCT06463457
View directory record Official record
Conditions
Prostate Cancer, Advanced Prostate Cancer, Hormone Sensitive Prostate Cancer
Interventions
Darolutamide, Relugolix
Drug
Lead sponsor
Atish Choudhury, MD
Other
Eligibility
18 Years and older · Male only
Enrollment
33 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
3
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Mar 8, 2026 · Synced Sep 24, 2026, 2:48 AM EDT
Recruiting Phase 2Phase 3 Interventional

Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer

NCT04787744
View directory record Official record
Conditions
Prostate Cancer, Oligometastasis, Oligorecurrence, Recurrent Prostate Cancer, Metastatic Prostate Cancer, De Novo Prostate Cancer
Interventions
PET-directed Local Therapy using Surgery, PET-directed Local Therapy using Radiation, Salvage Local Therapy for locally recurrent disease, Goserelin, Histrelin, Leuprolide & Triptorelin, ADT + Nilutamide, Flutamide, & Bicalutamide, Degarelix & Relugolix, ADT + Docetaxel +/- prednisone, ADT + Abiraterone + Prednisone, ADT + Abiraterone + Methylprednisolone, ADT + Apalutamide, ADT + Enzalutamide, Prostate-directed Radiation for De novo oligometastatic prostate cancer
Procedure · Radiation · Other + 1 more
Lead sponsor
VA Office of Research and Development
Federal
Eligibility
18 Years and older · Male only
Enrollment
464 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2029
U.S. locations
20
States / cities
Long Beach, California • West Los Angeles, California • Washington D.C., District of Columbia + 17 more
Source: ClinicalTrials.gov public record
Updated Apr 7, 2026 · Synced Sep 24, 2026, 2:48 AM EDT
Recruiting Phase 2 Interventional

Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With High Risk or Very High Risk Prostate Cancer, The EnrichPSMA Trial

NCT07025369
View directory record Official record
Conditions
Prostate Adenocarcinoma, Stage IIC Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8
Interventions
Biospecimen Collection, Computed Tomography, Flotufolastat F-18 Gallium, Laparoscopic Radical Prostatectomy with Robotics, Pelvic Lymphadenectomy, Positron Emission Tomography, Relugolix
Procedure · Other · Drug
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years and older · Male only
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
1
States / cities
Scottsdale, Arizona
Source: ClinicalTrials.gov public record
Updated Sep 22, 2026 · Synced Sep 24, 2026, 2:48 AM EDT
Withdrawn Phase 2 Interventional

Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment

NCT06279195
View directory record Official record
Conditions
Pelvic Pain
Interventions
Relugolix (40 mg) /estradiol (1 mg)/norethisterone acetate (0.5 mg) oral tablet
Drug
Lead sponsor
Endeavor Health
Other
Eligibility
18 Years to 35 Years · Female only
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2025
U.S. locations
1
States / cities
Evanston, Illinois
Source: ClinicalTrials.gov public record
Updated Aug 27, 2025 · Synced Sep 24, 2026, 2:48 AM EDT
Recruiting Phase 2 Interventional

The SUGAR Study; SBRT and Relugolix) for Prostate Cancer

NCT06111781
View directory record Official record
Conditions
Prostate Cancer
Interventions
Relugolix 120 MG [Orgovyx], SBRT standard of care radiotherapy treatment
Drug · Radiation
Lead sponsor
Yale University
Other
Eligibility
18 Years and older · Male only
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
4
States / cities
New Haven, Connecticut • Lebanon, New Hampshire • New York, New York + 1 more
Source: ClinicalTrials.gov public record
Updated Sep 13, 2026 · Synced Sep 24, 2026, 2:48 AM EDT
Recruiting Not applicable Interventional

Trial Evaluating the Safety and Efficacy Of MR-Linac-Guided Radiotherapy as Salvage Treatment After External Beam Radiotherapy Recurrence (TUMORNATOR II)

NCT07142967
View directory record Official record
Conditions
Intraprostatic Prostate Cancer
Interventions
Stereotactic Body Radiation Therapy (SBRT), Androgen Deprivation Therapy (ADT)
Radiation · Drug
Lead sponsor
NYU Langone Health
Other
Eligibility
18 Years and older · Male only
Enrollment
28 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2030
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Jul 9, 2026 · Synced Sep 24, 2026, 2:48 AM EDT
Active, not recruiting Phase 2 Interventional

Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer

NCT06734130
View directory record Official record
Conditions
Metastatic Castration Sensitive Prostate Cancer
Interventions
Luteinizing Hormone-Releasing Hormone (LHRH) analog, Androgen Receptor Signal Inhibitor (ARSI), Docetaxel
Drug
Lead sponsor
H. Lee Moffitt Cancer Center and Research Institute
Other
Eligibility
18 Years and older · Male only
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
1
States / cities
Tampa, Florida
Source: ClinicalTrials.gov public record
Updated Mar 31, 2026 · Synced Sep 24, 2026, 2:48 AM EDT
Recruiting Phase 2 Interventional

Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer

NCT06330805
View directory record Official record
Conditions
Prostate Adenocarcinoma, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8
Interventions
Biospecimen Collection, Contrast Agent, Leuprolide, Magnetic Resonance Imaging, Physical Performance Testing, Relugolix
Procedure · Other · Drug
Lead sponsor
Ohio State University Comprehensive Cancer Center
Other
Eligibility
18 Years and older · Male only
Enrollment
70 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
1
States / cities
Columbus, Ohio
Source: ClinicalTrials.gov public record
Updated Mar 8, 2026 · Synced Sep 24, 2026, 2:48 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Bioavailability and Effect of Food on TAK-385 Tablet Formulations in Healthy Participants

NCT02396147
View directory record Official record
Conditions
Healthy Volunteers
Interventions
TAK-385 T2 Formulation, TAK-385 T4 Formulation B, TAK-385 T4 Formulation C
Drug
Lead sponsor
Takeda
Industry
Eligibility
18 Years to 55 Years · Male only
Enrollment
54 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015
U.S. locations
1
States / cities
Tempe, Arizona
Source: ClinicalTrials.gov public record
Updated Jul 24, 2016 · Synced Sep 24, 2026, 2:48 AM EDT
Completed Phase 3 Interventional Results available

SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain

NCT03654274
View directory record Official record
Conditions
Endometriosis
Interventions
Relugolix, Estradiol/norethindrone acetate
Drug
Lead sponsor
Myovant Sciences GmbH
Industry
Eligibility
18 Years to 51 Years · Female only
Enrollment
802 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2023
U.S. locations
60
States / cities
Andalusia, Alabama • Scottsdale, Arizona • Tucson, Arizona + 50 more
Source: ClinicalTrials.gov public record
Updated Aug 7, 2023 · Synced Sep 24, 2026, 2:48 AM EDT
Recruiting Phase 2 Interventional

Short Course ADT for High Risk Low/Intermediate Risk ARTERA Prostate Cancer

NCT07801664
View directory record Official record
Conditions
Prostate Cancer
Interventions
Androgen Deprivation Therapy (ADT), Radiotherapy
Drug · Radiation
Lead sponsor
NYU Langone Health
Other
Eligibility
18 Years and older · Male only
Enrollment
90 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Sep 2, 2026 · Synced Sep 24, 2026, 2:48 AM EDT
Active, not recruiting Phase 2 Interventional Results available

Testing Interruption of Hormonal Medications in Patients Responding Exceptionally to Therapy for Metastatic Prostate Cancer, (A-DREAM)

NCT05241860
View directory record Official record
Conditions
Castration-Sensitive Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8
Interventions
Pharmacotherapy Discontinuation, Follow-Up, Questionnaire Administration, Quality-of-Life Assessment
Other
Lead sponsor
Alliance for Clinical Trials in Oncology
Other
Eligibility
18 Years and older · Male only
Enrollment
79 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2033
U.S. locations
326
States / cities
Phoenix, Arizona • Fort Smith, Arkansas • Little Rock, Arkansas + 234 more
Source: ClinicalTrials.gov public record
Updated Aug 30, 2026 · Synced Sep 24, 2026, 2:48 AM EDT
Recruiting No phase listed Observational

Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring

NCT05739123
View directory record Official record
Conditions
Pregnancy Related, Pregnancy Complications, Pregnancy, High Risk
Interventions
Relugolix-Containing Product
Drug
Lead sponsor
Sumitomo Pharma Switzerland GmbH
Industry
Eligibility
0 Years and older · Female only
Enrollment
728 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2033
U.S. locations
1
States / cities
Wilmington, North Carolina
Source: ClinicalTrials.gov public record
Updated Aug 18, 2025 · Synced Sep 24, 2026, 2:48 AM EDT