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NCT03436745 · ClinicalTrials.gov registry record · Phase 1
The Effects of Castration on the Pharmacokinetics of Zolpidem After Single Dose Administration In Men With Prostate Cancer Undergoing Androgen Deprivation Therapy Compared to Normal Healthy Females
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT03436745: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT03436745 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03436745, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Background: Insomnia is associated with difficulty sleeping. The drug zolpidem is widely prescribed for insomnia. Women have reported worse effects from the drug than men. Women have higher amounts of zolpidem in their body that may persist after waking. Drug exposure may also depend on male hormones that change during prostate cancer therapy. Researchers want to see if these findings can provide a more-accurate dose to healthy women and men with prostate cancer. Objective: To study amounts of zolpidem in men who have been diagnosed with prostate cancer before they are castrated and after, and to compare these results to healthy women s. Eligibility: Men ages 18 and older who have been diagnosed with prostate cancer who are planning to receive androgen deprivation therapy (ADT) Healthy women age 18 and older Design: Participants will be screened with: Blood tests Physical exam Electrocardiogram (EKG) heart test Male participants will confirm their prostate cancer. This can be done with a tumor sample tissue from a previous surgery or a report from a doctor. Female participants may have a pregnancy test. Participants will be admitted to the clinic in the evening and stay overnight. They will: Take a 5 mg zolpidem tablet on an empty stomach around 11 p.m. Have blood drawn multiple times Have physical exams and EKGs Answer questions about their symptoms and medicines they are taking Male participants will have ADT as part of their standard cancer treatment. After that, the testosterone in their blood will be measured. They will repeat the overnight clinic stay. Participants will get a follow-up phone call after each stay.
Primary Outcome
AUC is a measure of the serum concentration of Zolpidem over time. It is used to characterize drug absorption. The AUC values will be compared between the time points for males to see if the AUC increases significantly. Pre-ADT males will be subtracted from the paired values in males once they are post-ADT and tested for a difference using a paired t-test with a two-sided 0.05 significance level, or a Wilcoxon signed rank test if the paired differences are not normally distributed.
Interventions
- DRUG Zolpidem
- DIAGNOSTIC_TEST ECG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-01-22 |
| Est. Completion | 2024-01-30 |
| Phase | Phase 1 |
Why NCT03436745 stopped before completion
NCT03436745 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Zolpidem is the first listed.
NCT03436745 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03436745 about?
NCT03436745 is a clinical study titled "The Effects of Castration on the Pharmacokinetics of Zolpidem After Single Dose Administration In Men With Prostate Cancer Undergoing Androgen Deprivation Therapy Compared to Normal Healthy Females". Background: Insomnia is associated with difficulty sleeping. The drug zolpidem is widely prescribed for insomnia. Women have reported worse effects from the drug than men. Women have higher amounts of zolpidem in their body that may persist after waking. Drug exposure may also depend on male hormon...
What is the current status of trial NCT03436745?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2019-01-22. Estimated completion is 2024-01-30.
What interventions are being tested in trial NCT03436745?
The interventions under investigation include: Zolpidem (DRUG), ECG (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03436745?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03436745's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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