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NCT01805089 · ClinicalTrials.gov registry record · Early Phase 1
Melatonin Versus Placebo in Breast Cancer
A Early Phase 1 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 95
- Enrollment target
NCT01805089: Completed Early Phase 1 study, sponsored by Dana-Farber Cancer Institute.
NCT01805089 is a Early Phase 1 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 95 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (79% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01805089, a Early Phase 1 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 95 participants
- Enrollment target
Study Summary
The purpose of this research study is to determine whether melatonin taken every night can affect blood levels of estrogen or IGF (insulin-growth factor levels). Both IGF and estrogen are normally produced in the body and may influence breast cancer risk. Melatonin is also naturally produced in the body. Laboratory studies have shown that melatonin may decrease cancer growth and influence estrogen and IGF levels. Melatonin's effects on sleep, hot flashes, and mood will also be measured.
Primary Outcome
Absolute plasma estradiol levels after 4 month course of melatonin or placebo, only 4 month level provided below.
Interventions
- DRUG Melatonin 3 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2006-10 |
| Est. Completion | 2009-07 |
| Phase | Early Phase 1 |
What the finished NCT01805089 record still lists
NCT01805089 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (79% higher).
The record links to 0 conditions, and to 1 intervention - of which Melatonin 3 mg is the first listed.
NCT01805089 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01805089 about?
NCT01805089 is a clinical study titled "Melatonin Versus Placebo in Breast Cancer". The purpose of this research study is to determine whether melatonin taken every night can affect blood levels of estrogen or IGF (insulin-growth factor levels). Both IGF and estrogen are normally produced in the body and may influence breast cancer risk. Melatonin is also naturally produced in the ...
What is the current status of trial NCT01805089?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 95 participants. The study started on 2006-10. Estimated completion is 2009-07.
What interventions are being tested in trial NCT01805089?
The interventions under investigation include: Melatonin 3 mg (DRUG).
Who is sponsoring clinical trial NCT01805089?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01805089's enrollment target sits among peer trials
95 226th of 2000 higher than 1,775 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
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