Effects of IAS in Men With Localized Biochemical Relapsed Prostate Cancer
NCT00223665, Phase 2, Completed, University of Washington; results first posted 2018-05-14
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effects of IAS in Men With Localized Biochemical Relapsed Prostate Cancer | ClinicalTrials.gov |
| NCT number | NCT00223665 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 102 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of Washington | ClinicalTrials.gov |
| Conditions | Prostate Cancer | ClinicalTrials.gov |
| Interventions | Flutamide, Leuprolide Acetate | ClinicalTrials.gov |
| First posted | 2005-09-22 | ClinicalTrials.gov |
| Last updated | 2018-08-07 | ClinicalTrials.gov |
| Results first posted | 2018-05-14 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Time to Androgen Independence of Serum Prostate-Specific Antigen (PSA) | From date of first treatment until the date of development of CR, metastatic progression, or study withdrawal, whichever came first, assessed up to 16 years. | Monthly Prostate-Specific Antigen (PSA) testing to assess the point at which each patient's disease stops responding to Androgen Deprivation Therapy (ADT). Androgen Independence (AI), also know as Castrate Resistance (CR), was defined as 2 serial rises in PSA while on ADT with Testosterone levels \<50 ng/dL. | ClinicalTrials.gov |
| Primary | Effect of IAS on Overall Survival. | From date of first treatment until the date of death or study withdrawal, whichever came first, assessed up to 16 years. | Assessment of overall survival measured as median time from completion of first full cycle of IAS until date of death from any cause. | ClinicalTrials.gov |
| Secondary | Change in Standardized Bone Mineral Density (BMD) of the Spine During IAS | From screening prior to first dose of ADT through the start of the second cycle of ADT. | Dual-energy x-ray absorptiometry (DEXA) scans were performed prior to first cycle of ADT, after completion of the first cycle of ADT, and prior to the start of the second cycle of ADT. Bone Mineral Density (BMD) was a assessed in g/cm\^2 as a indicator of bone health for each patient at each time point. | ClinicalTrials.gov |
| Secondary | Change in Standardized Bone Mineral Density (BMD) of the Left Hip During IAS | From screening prior to first dose of ADT through the start of the second cycle of ADT. | Dual-energy x-ray absorptiometry (DEXA) scans were performed prior to first cycle of ADT, after completion of the first cycle of ADT, and prior to the start of the second cycle of ADT. Bone Mineral Density (BMD) was a assessed in g/cm\^2 as a indicator of bone health. Percent change was assess for each patient at each time point. | ClinicalTrials.gov |
| Secondary | Development of Osteopenia (Bone Loss) During IAS | From screening prior to first dose of ADT through the start of the second cycle of ADT. | Dual-energy x-ray absorptiometry (DEXA) scans were performed prior to first cycle of ADT, after completion of the first cycle of ADT, and prior to the start of the second cycle of ADT. Bone Mineral Density (BMD) was a assessed in g/cm\^2 as a indicator of bone health for each patient at each time point. This measure was defined as the percentage of participants with normal BMD scores at baseline who developed Osteopenia after the first cycle of ADT. | ClinicalTrials.gov |
| Secondary | Testosterone Levels During IAS | Baseline, Month 3, Month 9, and Month 12 | Testosterone was measured at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT. | ClinicalTrials.gov |
| Secondary | Estradiol Levels During First Cycle of IAS | Baseline, Month 3, Month 9, and Month 12 | Estradiol was measured at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT. | ClinicalTrials.gov |
| Secondary | Score on Spatial Ability Test (Block Design) During First Cycle of IAS | Baseline, Month 3, Month 9, and Month 12 | Spatial Ability was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT. This assessment was based on the Wechsler Adult Intelligence Scale-Revised, Block Design sub-test and measures participants' ability to analyze and construct abstract figures from their component parts. The test allows a time limit of 3 minutes per design, for a total of nine designs. Score is based on total number of designs completed (max 9, min 0). | ClinicalTrials.gov |
| Secondary | Score on Spatial Ability Test (Mental Rotation) During First Cycle of IAS | Baseline, Month 3, Month 9, and Month 12 | Spatial Ability (Mental Rotation) was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT. This assessment was based on the Vandenberg \& Kuse (1978) Mental Rotation Test. Subjects are presented with line drawings of complex, three dimensional cubes on a computer screen. The subject must compare the two drawings and decide if they match. Score is based on number of correctly identified figures. | ClinicalTrials.gov |
| Secondary | Score on Executive Function Testing (Stroop Task) During First Cycle of IAS | Baseline, Month 3, Month 9, and Month 12 | Executive Function was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT. This assessment was based on the Stroop Color Word Interference Task. Subjects are asked to read 100 color words (red, green, blue), followed by identification of color blocks followed by reading the color of the ink and ignoring the word (e.g., the word 'blue' printed in green letters). Assessment was based on the amount of time needed to time to complete the assessment. | ClinicalTrials.gov |
| Secondary | Score on Verbal Memory Testing (Proactive Interference) During First Cycle of IAS | Baseline, Month 3, Month 9, and Month 12 | Verbal Memory was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT via the Proactive Interference (PI) task. The PI task involves participants listening to a list of 10 words from the same semantic category (e.g., articles of clothing), and then recalling as many of these words as possible.The procedure is repeated for a total of 4 trials. Assessment is based on the total number of words recalled. | ClinicalTrials.gov |
| Secondary | Score on Visual Working Memory Test During First Cycle of IAS | Baseline, Month 3, Month 9, and Month 12 | Visual Working Memory was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT. This task is based on the Subject Ordered Pointing Task (SOPT). The participant is shown a grid array of 10, 12 or 16 abstract designs and they must choose a new design with each refresh of the screen. Assessment is based on total number of errors. | ClinicalTrials.gov |
| Secondary | Score on Verbal Memory Testing (Story Recall) During First Cycle of IAS | Baseline, Month 3, Month 9, and Month 12 | Verbal Memory was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT via Story Recall. This task is based on the well known Wechsler Memory Scale -Revised Logical Memory task. Participants listened to two brief narratives (stories) and were asked to recall as much as possible immediately after hearing each story and following a 20-minute delay. Assessment was based on number of correctly recalled pieces of information after a delay. | ClinicalTrials.gov |
| Secondary | Score on Spatial Memory Testing During First Cycle of IAS | Baseline, Month 3, Month 9, and Month 12 | Spatial Memory was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT using the Puget Sound Route Learning Test. This test measured the ability to navigate a short route within a room. Three trials were administered followed by three trials of a new route using pictures placed on the floor as landmarks. A delayed recall is administered after twenty minutes. Performance was assessed based on number of correctly recalled sequences after a delay. | ClinicalTrials.gov |
| Secondary | Score on Verbal Ability/Fluency Testing During First Cycle of IAS | Baseline, Month 3, Month 9, and Month 12 | Verbal Ability/Fluency was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT. Participants were asked to verbally generate as many words beginning with a particular letter (e.g. P) within a 60 second period. Two trials were administered with two different letters. The total number of words generated was recorded for each letter and summed and analyzed. | ClinicalTrials.gov |
Outcomes 15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Time to Androgen Independence of Serum Prostate-Specific Antigen (PSA) | From date of first treatment until the date of development of CR, metastatic progression, or study withdrawal, whichever came first, assessed up to 16 years. | 62 subjects were evaluable for this outcome measure, defined as having completed first cycle of ADT (9 months), having a measurable treatment break afterwards, and having sufficient PSA measurements to assess androgen independence. | years | MEDIAN | ClinicalTrials.gov |
| PRIMARY | Effect of IAS on Overall Survival. | From date of first treatment until the date of death or study withdrawal, whichever came first, assessed up to 16 years. | 62 subjects were evaluable for this outcome measure, defined as having completed first cycle of ADT (9 months), having a measurable treatment break afterwards, and having sufficient data to assess survival status. | years | MEDIAN | ClinicalTrials.gov |
| SECONDARY | Change in Standardized Bone Mineral Density (BMD) of the Spine During IAS | From screening prior to first dose of ADT through the start of the second cycle of ADT. | 56 subjects were evaluable for this outcome measure, defined as meeting all of the following: having completed first cycle of ADT (9 months); no prior or concurrent use of bisphosphonates; a minimum of 3 DEXA scans: prior to cycle 1, after cycle 1, and prior to cycle 2. | Percent change in BMD | NUMBER | ClinicalTrials.gov |
| SECONDARY | Change in Standardized Bone Mineral Density (BMD) of the Left Hip During IAS | From screening prior to first dose of ADT through the start of the second cycle of ADT. | Out of 102 enrolled subjects, 56 were evaluable for this outcome measure, defined as having completed first cycle of ADT (9 months), no prior or concurrent use of bisphosphonates, and a minimum of 3 DEXA scans: prior to cycle 1, after cycle 1, and prior to cycle 2. | Percent change of BMD | NUMBER | ClinicalTrials.gov |
| SECONDARY | Development of Osteopenia (Bone Loss) During IAS | From screening prior to first dose of ADT through the start of the second cycle of ADT. | 38 subjects were evaluable for this outcome measure, defined as meeting all of the following: having completed first cycle of ADT (9 months); no prior or concurrent use of bisphosphonates; a minimum of 3 DEXA scans: prior to cycle 1, after cycle 1, and prior to cycle 2; having baseline DEXA BMD within normal range at both spine and left hip. | percent of participants | NUMBER | ClinicalTrials.gov |
| SECONDARY | Testosterone Levels During IAS | Baseline, Month 3, Month 9, and Month 12 | Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having testosterone measurements at each of the listed time points. | ng/ml | MEAN | ClinicalTrials.gov |
| SECONDARY | Estradiol Levels During First Cycle of IAS | Baseline, Month 3, Month 9, and Month 12 | Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having estradiol measurements at each of the listed time points. | pg/ml | MEAN | ClinicalTrials.gov |
| SECONDARY | Score on Spatial Ability Test (Block Design) During First Cycle of IAS | Baseline, Month 3, Month 9, and Month 12 | Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having these neuro-psychological assessments at each of the listed time points. | Number of correctly completed designs | MEAN | ClinicalTrials.gov |
| SECONDARY | Score on Spatial Ability Test (Mental Rotation) During First Cycle of IAS | Baseline, Month 3, Month 9, and Month 12 | Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having these neuro-psychological assessments at each of the listed time points. | Number of correctly identified figures | MEAN | ClinicalTrials.gov |
| SECONDARY | Score on Executive Function Testing (Stroop Task) During First Cycle of IAS | Baseline, Month 3, Month 9, and Month 12 | Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having these neuro-psychological assessments at each of the listed time points. | minutes to complete the assessment | MEAN | ClinicalTrials.gov |
| SECONDARY | Score on Verbal Memory Testing (Proactive Interference) During First Cycle of IAS | Baseline, Month 3, Month 9, and Month 12 | Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having these neuro-psychological assessments at each of the listed time points. | Number of correctly recalled words | MEAN | ClinicalTrials.gov |
| SECONDARY | Score on Visual Working Memory Test During First Cycle of IAS | Baseline, Month 3, Month 9, and Month 12 | Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having these neuro-psychological assessments at each of the listed time points. | total number of errors | MEAN | ClinicalTrials.gov |
| SECONDARY | Score on Verbal Memory Testing (Story Recall) During First Cycle of IAS | Baseline, Month 3, Month 9, and Month 12 | Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having these neuro-psychological assessments at each of the listed time points. | number of correctly recalled data points | MEAN | ClinicalTrials.gov |
| SECONDARY | Score on Spatial Memory Testing During First Cycle of IAS | Baseline, Month 3, Month 9, and Month 12 | Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having these neuro-psychological assessments at each of the listed time points. | number of correctly recalled sequences | MEAN | ClinicalTrials.gov |
| SECONDARY | Score on Verbal Ability/Fluency Testing During First Cycle of IAS | Baseline, Month 3, Month 9, and Month 12 | Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having these neuro-psychological assessments at each of the listed time points. | Number of words generated | MEAN | ClinicalTrials.gov |
Results by group 47
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Time to Androgen Independence of Serum Prostate-Specific Antigen (PSA) | Intermittent Androgen Suppression (IAS) | 4.0 | Full Range 0.5 to 8.6 | years | ClinicalTrials.gov | |
| Effect of IAS on Overall Survival. | Intermittent Androgen Suppression (IAS) | 6.6 | Full Range 2.9 to 13.0 | years | ClinicalTrials.gov | |
| Change in Standardized Bone Mineral Density (BMD) of the Spine During IAS | Intermittent Androgen Suppression (IAS) | Post Cycle 1 versus Baseline | -3.4 | Percent change in BMD | ClinicalTrials.gov | |
| Change in Standardized Bone Mineral Density (BMD) of the Spine During IAS | Intermittent Androgen Suppression (IAS) | Pre Cycle 2 versus Post Cycle 1 | 1.4 | Percent change in BMD | ClinicalTrials.gov | |
| Change in Standardized Bone Mineral Density (BMD) of the Left Hip During IAS | Intermittent Androgen Suppression (IAS) | Post Cycle 1 versus Baseline | -1.2 | Percent change of BMD | ClinicalTrials.gov | |
| Change in Standardized Bone Mineral Density (BMD) of the Left Hip During IAS | Intermittent Androgen Suppression (IAS) | Pre Cycle 2 versus Post Cycle 1 | -0.2 | Percent change of BMD | ClinicalTrials.gov | |
| Development of Osteopenia (Bone Loss) During IAS | Intermittent Androgen Suppression (IAS) | 13.2 | percent of participants | ClinicalTrials.gov | ||
| Testosterone Levels During IAS | Intermittent Androgen Suppression (IAS) | Baseline | 406 | Standard Deviation 1.6 | ng/ml | ClinicalTrials.gov |
| Testosterone Levels During IAS | Intermittent Androgen Suppression (IAS) | Measurement at Month 3 | 0.28 | Standard Deviation 0.24 | ng/ml | ClinicalTrials.gov |
| Testosterone Levels During IAS | Intermittent Androgen Suppression (IAS) | Measurement at Month 9 | 0.20 | Standard Deviation 0.07 | ng/ml | ClinicalTrials.gov |
| Testosterone Levels During IAS | Intermittent Androgen Suppression (IAS) | Measurement at Month 12 | 2.45 | Standard Deviation 1.35 | ng/ml | ClinicalTrials.gov |
| Estradiol Levels During First Cycle of IAS | Intermittent Androgen Suppression (IAS) | Baseline | 33.60 | Standard Deviation 17.29 | pg/ml | ClinicalTrials.gov |
| Estradiol Levels During First Cycle of IAS | Intermittent Androgen Suppression (IAS) | Measurement at Month 3 | 23.12 | Standard Deviation 6.56 | pg/ml | ClinicalTrials.gov |
| Estradiol Levels During First Cycle of IAS | Intermittent Androgen Suppression (IAS) | Measurement at Month 9 | 22.76 | Standard Deviation 5.75 | pg/ml | ClinicalTrials.gov |
| Estradiol Levels During First Cycle of IAS | Intermittent Androgen Suppression (IAS) | Measurement at Month 12 | 24.35 | Standard Deviation 6.46 | pg/ml | ClinicalTrials.gov |
| Score on Spatial Ability Test (Block Design) During First Cycle of IAS | Combined Androgen Blockade | Baseline | 8.65 | Standard Deviation 0.81 | Number of correctly completed designs | ClinicalTrials.gov |
| Score on Spatial Ability Test (Block Design) During First Cycle of IAS | Combined Androgen Blockade | Score at Month 3 | 7.20 | Standard Deviation 1.21 | Number of correctly completed designs | ClinicalTrials.gov |
| Score on Spatial Ability Test (Block Design) During First Cycle of IAS | Combined Androgen Blockade | Score at Month 9 | 8.82 | Standard Deviation 0.53 | Number of correctly completed designs | ClinicalTrials.gov |
| Score on Spatial Ability Test (Block Design) During First Cycle of IAS | Combined Androgen Blockade | Score at Month 12 | 8.47 | Standard Deviation 1.06 | Number of correctly completed designs | ClinicalTrials.gov |
| Score on Spatial Ability Test (Mental Rotation) During First Cycle of IAS | Intermittent Androgen Suppression (IAS) | Baseline | 16.12 | Standard Deviation 3.39 | Number of correctly identified figures | ClinicalTrials.gov |
Participant flow 3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Intermittent Androgen Suppression (IAS) | 102 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Intermittent Androgen Suppression (IAS) | 102 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Intermittent Androgen Suppression (IAS) | 0 | ClinicalTrials.gov |
Adverse events 17
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | depression | Psychiatric disorders | Combined Androgen Blockade | 5 | 102 | 102 | ClinicalTrials.gov |
| other | fatigue | General disorders | Combined Androgen Blockade | 9 | 102 | 102 | ClinicalTrials.gov |
| other | hot flashes | General disorders | Combined Androgen Blockade | 14 | 102 | 102 | ClinicalTrials.gov |
| other | hyperlipidemia | Investigations | Combined Androgen Blockade | 9 | 102 | 102 | ClinicalTrials.gov |
| other | hypertension | Cardiac disorders | Combined Androgen Blockade | 6 | 102 | 102 | ClinicalTrials.gov |
| other | urinary incontinence | Renal and urinary disorders | Combined Androgen Blockade | 12 | 102 | 102 | ClinicalTrials.gov |
| other | nocturia | Renal and urinary disorders | Combined Androgen Blockade | 15 | 102 | 102 | ClinicalTrials.gov |
| other | osteopenia | Musculoskeletal and connective tissue disorders | Combined Androgen Blockade | 5 | 102 | 102 | ClinicalTrials.gov |
| other | pain, bone and muscle | Musculoskeletal and connective tissue disorders | Combined Androgen Blockade | 6 | 102 | 102 | ClinicalTrials.gov |
| other | renal insufficiency | Renal and urinary disorders | Combined Androgen Blockade | 5 | 102 | 102 | ClinicalTrials.gov |
| other | weight gain | General disorders | Combined Androgen Blockade | 6 | 102 | 102 | ClinicalTrials.gov |
| serious | pnemonia | Respiratory, thoracic and mediastinal disorders | Combined Androgen Blockade | 1 | 102 | 1 | ClinicalTrials.gov |
| serious | GI bleed | Gastrointestinal disorders | Combined Androgen Blockade | 1 | 102 | 3 | ClinicalTrials.gov |
| serious | Atrioventricular node ablation | Cardiac disorders | Combined Androgen Blockade | 1 | 102 | 1 | ClinicalTrials.gov |
| serious | exacerbation of claudication | Musculoskeletal and connective tissue disorders | Combined Androgen Blockade | 1 | 102 | 1 | ClinicalTrials.gov |
| serious | stroke | Nervous system disorders | Combined Androgen Blockade | 1 | 102 | 1 | ClinicalTrials.gov |
| serious | left hip pain | Musculoskeletal and connective tissue disorders | Combined Androgen Blockade | 1 | 102 | 1 | ClinicalTrials.gov |
Adverse event totals 3
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Combined Androgen Blockade | 33 | 102 | ClinicalTrials.gov |
| Total, other adverse events | Combined Androgen Blockade | 91 | 102 | ClinicalTrials.gov |
| Total, serious adverse events | Combined Androgen Blockade | 5 | 102 | ClinicalTrials.gov |
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 25242417 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Mental Rotation | Secondary outcome | ConductCognition |
| Short Story Recall | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)