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NCT04535323 · ClinicalTrials.gov registry record · Phase 1
Platelet Rich Plasma for the Treatment of Genitourinary Syndrome of Menopause in Patients With Stage 0-III Breast Cancer
A Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT04535323: Completed Phase 1 study, sponsored by Mayo Clinic.
NCT04535323 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04535323, a Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This phase I trial is to find out possible benefits and/or side effects of platelet rich plasma for the treatment of genitourinary syndrome of menopause in patients with stage 0-III breast cancer. Platelet rich plasma is produced by collecting approximately 60-90 ml (4-6 tablespoons) of blood from the vein in patients' arm. The blood is spun using a centrifuge that separates the plasma and red blood cells. This allows doctors to collect the platelet rich plasma that is then loaded into individual, sterile syringes for injection. Giving platelet rich plasma may help relief symptoms of genitourinary syndrome of menopause in patients with breast cancer.
Primary Outcome
Safety endpoint is defined as a lack of serious adverse events. National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) will be used to grade the severity of adverse events that occur in this study.
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- BIOLOGICAL Therapeutic Autologous Platelet-rich Plasma
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-09-23 |
| Est. Completion | 2024-01-10 |
| Phase | Phase 1 |
What the finished NCT04535323 record still lists
NCT04535323 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 3 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04535323 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04535323 about?
NCT04535323 is a clinical study titled "Platelet Rich Plasma for the Treatment of Genitourinary Syndrome of Menopause in Patients With Stage 0-III Breast Cancer". This phase I trial is to find out possible benefits and/or side effects of platelet rich plasma for the treatment of genitourinary syndrome of menopause in patients with stage 0-III breast cancer. Platelet rich plasma is produced by collecting approximately 60-90 ml (4-6 tablespoons) of blood from t...
What is the current status of trial NCT04535323?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2020-09-23. Estimated completion is 2024-01-10.
What interventions are being tested in trial NCT04535323?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Therapeutic Autologous Platelet-rich Plasma (BIOLOGICAL).
Who is sponsoring clinical trial NCT04535323?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04535323's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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
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