Trial · NCT05679388
A Study of Extending Relugolix Dosing Intervals Through Addition of Itraconazole or Ritonavir in Prostate Cancer Patients
NCT05679388, Phase 1, Terminated, University of Chicago
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Extending Relugolix Dosing Intervals Through Addition of Itraconazole or Ritonavir in Prostate Cancer Patients. Trials, record NCT05679388. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05679388
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Extending Relugolix Dosing Intervals Through Addition of Itraconazole or Ritonavir in Prostate Cancer Patients
- NCT number
- NCT05679388
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 60 participants, actual
- Lead sponsor
- University of Chicago
- Conditions
- Prostate Cancer, Prostate Cancer Metastatic, Prostate Adenocarcinoma
- Interventions
- Relugolix Pill, Ritonavir, Itraconazole
- First posted
- 2023-01-11
- Last updated
- 2024-09-19
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Testosterone Suppression of Participants as Assessed by Testosterone Levels | 1 month post start of treatment | To determine whether the addition of itraconazole and ritonavir to relugolix sustains testosterone suppression as assessed by participant testosterone levels. |
| Secondary | Decrease in Relugolix Levels | 1 month post start of treatment | To evaluate whether itraconazole or ritonavir significantly decreases relugolix clearance in participants with prostate cancer as assessed by relugolix serum levels on days 8 and 15. |
| Secondary | Reduction in Prostate-Specific Antigens Levels of Participants After Study Treatment | 1 month post start of treatment | To evaluate the efficacy of itraconazole or ritonavir combined with relugolix in patients with prostate cancer as assessed by a reduction in Prostate-Specific Antigen (PSA) levels of patients after study treatment. |
| Secondary | Rate of Reported Adverse Events Among Participants | 1 month post start of treatment | To evaluate the safety of itraconazole or ritonavir combined with longer interval relugolix dosing regimens in patients with prostate cancer as assessed by the rate of reported adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) V5. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05679388
GET https://conductscience.org/api/trials/v1/NCT05679388/registered