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NCT02670343 · ClinicalTrials.gov registry record · Phase 1
Phlebotomy Study of Testosterone Undecanoate
A Phase 1 study, sponsored by Clarus Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT02670343: Completed Phase 1 study, sponsored by Clarus Therapeutics.
NCT02670343 is a Phase 1 study that has completed, run by Clarus Therapeutics. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02670343, a Phase 1 study, has completed, sponsored by Clarus Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
An open-label, single oral TU dose study was conducted in eight (8) hypogonadal men at a single study site. Each study participant received a single oral TU dose immediately prior to a standardized breakfast meal comprised of 800 to 1000 calories and approximately 30 g of fat. Blood samples were collected 30 minutes prior dose administration and at 0 pre-dose and post dose at the following hours post-dose; 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours.
Primary Outcome
The measured outcome presented is the difference as a percent of mean of T results when comparing T Concentrations measured in three different types of NaF containing collection tubes (NaF+EDTA, NaF+Oxalate and NaF) to T measured in blood collected in plain tubes. The % of Mean Difference in T concentration for each tube type was obtained by taking the average at each time point a T concentration was obtained, and calculating the mean difference between the test ((NaF+EDTA, NaF+Oxalate and NaF)
Interventions
- DRUG Oral Testosterone Undecanoate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2016-01 |
| Est. Completion | 2016-03 |
| Phase | Phase 1 |
What the finished NCT02670343 record still lists
NCT02670343 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Oral Testosterone Undecanoate is the first listed.
NCT02670343 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02670343 about?
NCT02670343 is a clinical study titled "Phlebotomy Study of Testosterone Undecanoate". An open-label, single oral TU dose study was conducted in eight (8) hypogonadal men at a single study site. Each study participant received a single oral TU dose immediately prior to a standardized breakfast meal comprised of 800 to 1000 calories and approximately 30 g of fat. Blood samples were col...
What is the current status of trial NCT02670343?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2016-01. Estimated completion is 2016-03.
What interventions are being tested in trial NCT02670343?
The interventions under investigation include: Oral Testosterone Undecanoate (DRUG).
Who is sponsoring clinical trial NCT02670343?
This trial is sponsored by Clarus Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02670343's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 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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