Relugolix
DrugRelugolix 120-mg tablet administered orally once daily following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1
Other names: TAK-385, MVT-601, RVT-601, T-1331285, ORGOVYX
NCT Number: NCT05467176
This is a multi-center, prospective, observational study of patients being treated with ORGOVYX. The goal of this study is to generate real-world evidence about the safety and effectiveness of ORGOVYX in patients with prostate cancer in routine clinical care and the clinical course during treatment with and following cessation of ORGOVYX.
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Notify Me18 year and older
Male
Observational
Urology Centers of Alabama, Homewood, Alabama, United States
This prospective observational cohort study will be conducted in patients who are initiating treatment or have initiated treatment with ORGOVYX within the 1 month prior to the time of study enrollment and who remain on treatment at the time of enrollment. The decision to initiate treatment with ORGOVYX should be made prior to study enrollment. The study is designed to better understand the actual experience of patients with prostate cancer treated with ORGOVYX by collecting data on treatment patterns, adherence, and selective safety data. Additionally, a better understanding of the trajectory of patients with prostate cancer following cessation of ORGOVYX therapy will be gained by observing the clinical course of the disease, health outcomes, and health-related quality-of-life (HRQoL) in these patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Relugolix 120-mg tablet administered orally once daily following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1
Other names: TAK-385, MVT-601, RVT-601, T-1331285, ORGOVYX
Time frame: Up to 5 years
Patient demographics
Time frame: Up to 5 years
Incidence of treatment-related serious adverse events and any adverse events resulting in discontinuation of ORGOVYX as reported by physician or patient.
Time frame: Up to 5 years
Changes to health-related quality-of-life indicators as measured by patient-reported outcomes (PROs)
Time frame: Up to 5 years
Clinical characteristics of patients
Time frame: Up to 5 years
Changes in disease stage and clinical treatment
Time frame: Up to 5 years
Any deaths that occur during the study
Time frame: Up to 5 years
Changes in co-morbidities (presence and/or severity) as assessed by patient's physician
Time frame: Up to 5 years
Describe patient adherence and persistence including reasons for change with ORGOVYX treatment
Sumitomo Pharma America, Inc.
Industry
Acronym: OPTYX
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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