A Study to Learn How Men With Advanced Prostate Cancer Respond to Treatment With Darolutamide and Hormone Therapy, With or Without Chemotherapy, in Real-world Medical Practice (ROAD)

July 3, 2026 updated by: Bayer

ROAD - Real-World Outcomes of Darolutamide, ADT, With or Without Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer

This is an international, prospective, open-label, multicenter, multi-cohort, non-interventional observational study designed to describe the real-world effectiveness and safety of darolutamide in combination with androgen deprivation therapy (ADT), with or without docetaxel, in patients with metastatic hormone-sensitive prostate cancer (mHSPC). The study aims to enroll approximately 1,600 male patients (800 per cohort) from multiple countries, primarily in Europe, who have a diagnosis of mHSPC and for whom a decision to treat with darolutamide has been made by the treating physician prior to enrollment. The primary objective is to estimate the proportion of patients achieving undetectable prostate-specific antigen (PSA) levels (<0.2 ng/mL) at 1 year of treatment in each cohort. Secondary objectives include describing patient demographics, clinical characteristics, prior and concomitant treatments, adverse events, and clinical effectiveness measures such as overall survival, time to new treatment, time to castration resistance, and time to PSA progression. Further objectives involve assessing quality of life, reasons for not adding docetaxel, outcomes by patient subgroups (e.g., Gleason score, disease volume, ECOG status), genomic testing results, and hospitalization rates. Data will be collected using electronic case report forms (eCRF) during routine clinical practice, with no additional diagnostic or monitoring procedures required beyond standard care. All patients must provide informed consent prior to participation. The study will comply with applicable regulatory requirements, including IEC/IRB approval in all participating countries. Statistical analyses will be descriptive and exploratory, with interim analyses planned after 200, 400, and 600 patients per cohort have completed at least 12 months of treatment or discontinued therapy. The study is expected to provide valuable insights into the real-world use of darolutamide in mHSPC, supporting clinical decision-making and enhancing understanding of treatment patterns, effectiveness, and safety in diverse patient populations.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Multiple Locations, Belgium
        • Many locations
  • Finland
      • Multiple Locations, Finland
        • Many locations
  • France
      • Multiple Locations, France
        • Many locations
  • Germany
      • Multiple Locations, Germany
        • Many locations
  • Greece
      • Multiple Locations, Greece
        • Many locations
  • Israel
      • Multiple Locations, Israel
        • Many locations
  • Italy
      • Multiple Locations, Italy
        • Many locations
  • Lithuania
      • Multiple Locations, Lithuania
        • Many locations
  • Norway
      • Multiple Locations, Norway
        • Many locations
  • Poland
      • Multiple Locations, Poland
        • Many locations
  • Portugal
      • Multiple Locations, Portugal
        • Many locations
  • Saudi Arabia
      • Multiple Locations, Saudi Arabia
        • Many locations
  • Spain
      • Multiple Locations, Spain
        • Many locations
  • Sweden
      • Multiple Locations, Sweden
        • Many locations
  • Switzerland
      • Multiple Locations, Switzerland
        • Many locations
  • United Kingdom
      • Multiple Locations, United Kingdom
        • Many locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Male patients with a diagnosis of metastatic hormone-sensitive prostate cancer (mHSPC) for whom a decision to treat with darolutamide has been made by the treating physician prior to enrollment.

Description

Inclusion Criteria:

  • Male patient with a diagnosis of mHSPC
  • Male aged ≥18 years (or country's legal age of adulthood if >18 years)
  • Histologically or cytologically confirmed adenocarcinoma of prostate; may have begun ADT (up to 120 days prior to enrollment)
  • Metastatic disease by conventional or new generation imaging
  • Decision to initiate treatment with darolutamide with or without docetaxel made prior to enrollment
  • Signed informed patient consent before start of data collection
  • Life expectancy of ≥3 months based on clinical judgment

Exclusion Criteria:

  • Participation in an investigational program with interventions outside of routine clinical practice
  • Contraindications according to local marketing authorization
  • Any prior treatment with second-generation AR inhibitors (enzalutamide, apalutamide, or investigational AR inhibitors), CYP17 inhibitors (abiraterone acetate or investigational CYP17 inhibitors) as antineoplastic treatment for prostate cancer
  • Prior hormone therapy in the metastatic setting
  • Treatment with darolutamide initiated more than 7 days prior to enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Darolutamide + ADT + Docetaxel (Triplet therapy)
This group includes men with metastatic hormone-sensitive prostate cancer (mHSPC) who are treated with a combination of darolutamide, androgen deprivation therapy (ADT), and docetaxel. The decision to use this triplet therapy is made by the treating physician as part of routine clinical practice before the patient enrolls in the study. Patients in this cohort receive all three treatments according to local standard of care.
Drug: Darolutamide (BAY 1841788)
Darolutamide administered per local standard of care in combination with ADT.
Other Names:
  • NUBEQA
Drug: ADT
Androgen deprivation therapy administered per local standard of care.
Drug: Docetaxel
Docetaxel administered per local standard of care in combination with darolutamide and ADT for cohort 1.
Darolutamide + ADT (Doublet therapy)
This group includes men with metastatic hormone-sensitive prostate cancer (mHSPC) who are treated with darolutamide and androgen deprivation therapy (ADT), but without docetaxel. The decision to use this doublet therapy is made by the treating physician as part of routine clinical practice before the patient enrolls in the study. Patients in this cohort receive darolutamide and ADT according to local standard of care.
Drug: Darolutamide (BAY 1841788)
Darolutamide administered per local standard of care in combination with ADT.
Other Names:
  • NUBEQA
Drug: ADT
Androgen deprivation therapy administered per local standard of care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of patients in cohort 1 achieving undetectable PSA (<0.2 ng/mL) at 1 year
Time Frame: after 1 year of treatment
To describe the effectiveness of darolutamide + ADT + docetaxel in patients with mHSPC by means of estimating the prostate-specific antigen (PSA) undetectable rates (PSA<0.2 ng/mL) after 1 year of study treatment.
after 1 year of treatment
Proportion of patients in cohort 2 achieving undetectable PSA (<0.2 ng/mL) at 1 year
Time Frame: after 1 year of treatment
To describe the effectiveness of darolutamide + ADT in patients with mHSPC by means of estimating the prostate-specific antigen (PSA) undetectable rates (PSA<0.2 ng/mL) after 1 year of study treatment.
after 1 year of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival per cohort and per country
Time Frame: up to 4 years
Time from start of darolutamide treatment until death from any cause.
up to 4 years
Overall survival per cohort in all countries
Time Frame: up to 4 years
Time from start of darolutamide treatment until death from any cause.
up to 4 years
Time to subsequent treatment per cohort and per country
Time Frame: up to 4 years
Time from start of darolutamide treatment to initiation of a new anti-cancer therapy.
up to 4 years
Time to subsequent treatment per cohort in all countries
Time Frame: up to 4 years
Time from start of darolutamide treatment to initiation of a new anti-cancer therapy.
up to 4 years
Time to castration resistance (CRPC) per cohort and per country
Time Frame: up to 4 years
Time from enrollment until documented clinical or PSA progression with testosterone level <50 ng/dL or documented medical/surgical castration.
up to 4 years
Time to castration resistance (CRPC) per cohort in all countries
Time Frame: up to 4 years
Time from enrollment until documented clinical or PSA progression with testosterone level <50 ng/dL or documented medical/surgical castration.
up to 4 years
Time to PSA progression per cohort and per country
Time Frame: up to 4 years
Time from start of darolutamide treatment to PSA progression (≥25% increase above nadir and ≥2 ng/mL, confirmed by a second value ≥3 weeks later, but prior to 6 months, while on treatment).
up to 4 years
Time to PSA progression per cohort in all countries
Time Frame: up to 4 years
Time from start of darolutamide treatment to PSA progression (≥25% increase above nadir and ≥2 ng/mL, confirmed by a second value ≥3 weeks later, but prior to 6 months, while on treatment).
up to 4 years
PSA response rate per cohort and per country
Time Frame: 1 year
Proportion of patients with blood PSA level <0.2 ng/mL, confirmed by a second subsequent PSA value <0.2 ng/mL 3 or more weeks later
1 year
PSA response rate per cohort in all countries
Time Frame: 1 year
Proportion of patients with blood PSA level <0.2 ng/mL, confirmed by a second subsequent PSA value <0.2 ng/mL 3 or more weeks later
1 year
Survival rate per cohort and per country
Time Frame: up to 4 years
Survival rate at specified time points.
up to 4 years
Survival rate per cohort and all countries
Time Frame: up to 4 years
Survival rate at specified time points.
up to 4 years
Time to discontinuation per cohort and per country
Time Frame: up to 4 years
Time from start of darolutamide treatment to permanent discontinuation or death
up to 4 years
Time to discontinuation per cohort in all countries
Time Frame: up to 4 years
Time from start of darolutamide treatment to permanent discontinuation or death
up to 4 years
Reason for discontinuation percohort and per country
Time Frame: up to 4 years
Reason for permanent darolutamide discontinuation
up to 4 years
Reason for discontinuation per cohort in all countries
Time Frame: up to 4 years
Reason for permanent darolutamide discontinuation
up to 4 years
Patient demographics per cohort and per country
Time Frame: at baseline
Demographic characteristics at the first documented regular visit ion the study, referred to as baseline).
at baseline
Patient demographics per cohort in all countries
Time Frame: at baseline
Demographic characteristics at the first documented regular visit ion the study, referred to as baseline).
at baseline
Medical History per cohort and per country
Time Frame: at baseline
The medical history will be documented at study start.
at baseline
Medical History per cohort in all countries
Time Frame: at baseline
The medical history will be documented at study start.
at baseline
Concomitant medication per cohort and per country
Time Frame: up to 4 years
Documentation of Concomitant medication.
up to 4 years
Concomitant medication per cohort in all countries
Time Frame: up to 4 years
Documentation of Concomitant medication.
up to 4 years
Concomitant treatment per cohort and per country
Time Frame: up to 4 years
Documentation of Concomitant treatments.
up to 4 years
Concomitant treatment per cohort in all countries
Time Frame: up to 4 years
Documentation of Concomitant treatments.
up to 4 years
Darolutamide use per cohort and per country
Time Frame: up to 4 years
To describe real-world use of darolutamide in mHSPC patients.
up to 4 years
Darolutamide use per cohort in all countries
Time Frame: up to 4 years
To describe real-world use of darolutamide in mHSPC patients.
up to 4 years
Diagnostic Imaging Technology per cohort and per country
Time Frame: at baseline
Documentation of Diagnostic Imaging Technology at the initial study visits (baseline).
at baseline
Diagnostic Imaging Technology per cohort in all countries
Time Frame: at baseline
Documentation of Diagnostic Imaging Technology at the initial study visits (baseline).
at baseline
Adverse events per cohort and per country
Time Frame: up to 4 years
Number of all adverse events.
up to 4 years
Adverse events per cohort in all countries
Time Frame: up to 4 years
Number of all adverse events.
up to 4 years
Serious Adverse events per cohort and per country
Time Frame: up to 4 years
Number of all serious adverse events.
up to 4 years
Serious Adverse events per cohort in all countries
Time Frame: up to 4 years
Number of all serious adverse events.
up to 4 years
Drug-related Adverse events per cohort and per country
Time Frame: up to 4 years
Number of all drug-related (darolutamide) adverse events.
up to 4 years
Drug-related Adverse events per cohort in all countries
Time Frame: up to 4 years
Number of all drug-related (darolutamide) adverse events.
up to 4 years
Serious Drug-related Adverse events per cohort and per country
Time Frame: up to 4 years
Number of all serious drug-related (darolutamide) adverse events.
up to 4 years
Serious Drug-related Adverse events per cohort in all countries
Time Frame: up to 4 years
Number of all serious drug-related (darolutamide) adverse events.
up to 4 years
Adverse events leading to treatment discontinuation per cohort and per country
Time Frame: up to 4 years
Number of adverse events leading to treatment discontinuation.
up to 4 years
Adverse events leading to treatment discontinuation per cohort in all countries
Time Frame: up to 4 years
Number of adverse events leading to treatment discontinuation.
up to 4 years
Vital Signs: Blood Pressure per cohort and per country
Time Frame: up to 4 years
Blood Pressure is measured in mmHg throughout the study, at all major visit types, over the full observation period.
up to 4 years
Vital Signs: Blood Pressure per cohort in all countries
Time Frame: up to 4 years
Blood Pressure is measured in mmHg throughout the study, at all major visit types, over the full observation period.
up to 4 years
Vital Signs: Body Temperature per cohort and per country
Time Frame: up to 4 years
Body Temperature is measured in degrees Celsius (°C) or Fahrenheit (°F) (as per local practice) throughout the study, at all major visit types, over the full observation period.
up to 4 years
Vital Signs: Body Temperature per cohort in all countries
Time Frame: up to 4 years
Body Temperature is measured in degrees Celsius (°C) or Fahrenheit (°F) (as per local practice) throughout the study, at all major visit types, over the full observation period.
up to 4 years
Vital Signs: Weight per cohort and per country
Time Frame: up to 4 years
Weight is measured in kilograms (kg) throughout the study, at all major visit types, over the full observation period.
up to 4 years
Vital Signs: Weight per cohort in all countries
Time Frame: up to 4 years
Weight is measured in kilograms (kg) throughout the study, at all major visit types, over the full observation period.
up to 4 years
Vital Signs: Height per cohort and per country
Time Frame: up to 4 years
Height is measured in centimeters (cm) throughout the study, at all major visit types, over the full observation period.
up to 4 years
Vital Signs: Height per cohort in all countries
Time Frame: up to 4 years
Height is measured in centimeters (cm) throughout the study, at all major visit types, over the full observation period.
up to 4 years
Laboratory Parameters: Hematology (Hemoglobin) per cohort and per country
Time Frame: up to 4 years
Hemoglobin (g/dL)) is determined throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.
up to 4 years
Laboratory Parameters: Hematology (Hemoglobin) per cohort in all countries
Time Frame: up to 4 years
Hemoglobin (g/dL)) is determined throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.
up to 4 years
Laboratory Parameters: Hematology (WBC) per cohort and per country
Time Frame: up to 4 years
White Blood Cell Count (WBC) (x10^9/L) is performed throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.
up to 4 years
Laboratory Parameters: Hematology (WBC) per cohort in all countries
Time Frame: up to 4 years
White Blood Cell Count (WBC) (x10^9/L) is performed throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.
up to 4 years
Laboratory Parameters: Hematology (Platelet Count) per cohort and per country
Time Frame: up to 4 years
Platelet Count (x10^9/L) is performed throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.
up to 4 years
Laboratory Parameters: Hematology (Platelet Count) per cohort in all countries
Time Frame: up to 4 years
Platelet Count (x10^9/L) is performed throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.
up to 4 years
Laboratory Parameters: Clinical Chemistry (Creatinine) per cohort and per country
Time Frame: up to 4 years
Serum Creatinine (mg/dL or µmol/L) is determined throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.
up to 4 years
Laboratory Parameters: Clinical Chemistry (Creatinine) per cohort in all countries
Time Frame: up to 4 years
Serum Creatinine (mg/dL or µmol/L) is determined throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.
up to 4 years
Laboratory Parameters: Clinical Chemistry (ALT) per cohort and per country
Time Frame: up to 4 years
Alanine Aminotransferase (ALT) (U/L) is determined throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.
up to 4 years
Laboratory Parameters: Clinical Chemistry (ALT) per cohort in all countries
Time Frame: up to 4 years
Alanine Aminotransferase (ALT) (U/L) is determined throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.
up to 4 years
Laboratory Parameters: Clinical Chemistry (AST) per cohort and per country
Time Frame: up to 4 years
Aspartate Aminotransferase (AST) (U/L) is determined throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.
up to 4 years
Laboratory Parameters: Clinical Chemistry (AST) per cohort in all countries
Time Frame: up to 4 years
Aspartate Aminotransferase (AST) (U/L) is determined throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.
up to 4 years
Laboratory Parameters: Clinical Chemistry (Bilirubin) per cohort and per country
Time Frame: up to 4 years
Total Bilirubin (mg/dL or µmol/L) is determined throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.
up to 4 years
Laboratory Parameters: Clinical Chemistry (Bilirubin) per cohort in all countries
Time Frame: up to 4 years
Total Bilirubin (mg/dL or µmol/L) is determined throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.
up to 4 years
Laboratory Parameters: Clinical Chemistry (Alkaline Phosphatase) per cohort and per country
Time Frame: up to 4 years
Alkaline Phosphatase (U/L) is determined throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.
up to 4 years
Laboratory Parameters: Clinical Chemistry (Alkaline Phosphatase) per cohort in all countries
Time Frame: up to 4 years
Alkaline Phosphatase (U/L) is determined throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.
up to 4 years
Laboratory Parameters: Clinical Chemistry (PSA) per cohort and per country
Time Frame: up to 4 years
Prostate-Specific Antigen (PSA) (ng/mL) is determined throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.
up to 4 years
Laboratory Parameters: Clinical Chemistry (PSA) per cohort in all countries
Time Frame: up to 4 years
Prostate-Specific Antigen (PSA) (ng/mL) is determined throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.
up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 29, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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