Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04265053 · ClinicalTrials.gov registry record · Early Phase 1
Human Cerebral Blood Flow Regulation
A Early Phase 1 study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 42
- Enrollment target
NCT04265053: Completed Early Phase 1 study, sponsored by University of Wisconsin, Madison.
NCT04265053 is a Early Phase 1 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 42 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04265053, a Early Phase 1 study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
To determine cerebrovascular control mechanisms in humans and provide mechanistic knowledge to offer new sex-specific therapeutic options for cerebrovascular diseases. The current objective is to determine how sex and sex hormones influence CBF control in healthy young adults without confounds of age or disease. The central hypothesis is men exhibit reduced cerebral vasodilator function due in part to differences in COX signaling compared to women. Comprehensive CBF data from multi-modal MRI indicate the magnitude of sex differences-as well as the vasodilator mechanisms-are regionally distinct. Research confounding variables like aging and disease will be mitigated by comparing younger adults (18-40 years old).
Primary Outcome
CVC is the ratio between Cerebral Blood Flow (CBF) and blood pressure (BP). Change in CVC in response to hypoxia between male and female groups, where baseline CVC is subtracted from hypoxia CVC. Hypoxia typically lasts about 20 minutes. The hypothesis is that women will exhibit 50-60% more vasodilation in response to hypoxia \[Aim 1\].
Interventions
- DRUG Indomethacin 25 MG/50 MG
- DRUG Placebo - Lactose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2021-04-12 |
| Est. Completion | 2025-05-31 |
| Phase | Early Phase 1 |
What the finished NCT04265053 record still lists
NCT04265053 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (21% lower).
The record links to 0 conditions, and to 2 interventions - of which Indomethacin 25 MG/50 MG is the first listed.
NCT04265053 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04265053 about?
NCT04265053 is a clinical study titled "Human Cerebral Blood Flow Regulation". To determine cerebrovascular control mechanisms in humans and provide mechanistic knowledge to offer new sex-specific therapeutic options for cerebrovascular diseases. The current objective is to determine how sex and sex hormones influence CBF control in healthy young adults without confounds of ag...
What is the current status of trial NCT04265053?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 42 participants. The study started on 2021-04-12. Estimated completion is 2025-05-31.
What interventions are being tested in trial NCT04265053?
The interventions under investigation include: Indomethacin 25 MG/50 MG (DRUG), Placebo - Lactose (DRUG).
Who is sponsoring clinical trial NCT04265053?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04265053's enrollment target sits among peer trials
42 605th of 2000 higher than 1,379 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02852213 · 42 participants · Phase 1
A Single-Stage, Adaptive, Open-label, Dose Escalation Safety and Efficacy Study of AADC Deficiency in Pediatric Patients
- NCT03136146 · 42 participants · Phase 2
Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma/Leukemia, or Double-Hit Lymphoma/Leukemia
- NCT03178149 · 42 participants · Phase 1
A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration
- NCT03663530 · 42 participants · NA
Circadian Misalignment and Energy Balance
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI