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NCT02921386 · ClinicalTrials.gov registry record · Phase 2
The Effect of Various Amounts of Fat on PK of Oral Testosterone Undecanoate
A Phase 2 study of Hypogonadism, sponsored by Clarus Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 2
- Study locations
NCT02921386: Completed Phase 2 study of Hypogonadism, sponsored by Clarus Therapeutics.
NCT02921386 is a Phase 2 study of Hypogonadism that has completed, run by Clarus Therapeutics. The registered enrollment target is 18 participants, below the 119-participant average among 21 other Hypogonadism trials with a reported enrollment target (85% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02921386, a Phase 2 study of Hypogonadism, has completed, sponsored by Clarus Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
- 2
- Study locations
Study Summary
A Phase 2, open-label, randomized, cross-over, pharmacokinetic study designed to determine the effect of meals of various amounts of fat given immediately prior to dosing on the pharmacokinetics of oral testosterone undecanoate. Approximately 20 hypogonadal subjects will be dosed for a 14 day run-in period. This will be followed by a randomized sequence of five periods over a 6 day confinement period. Subjects will receive a randomly ordered sequence of breakfast meals containing various amounts of fat, fasting, 15 g, 30 g, 45 g and a high fat breakfast consistent Guidance for Industry on Food-Effect Bioavailability and Fed Bioequivalence Studies.
Primary Outcome
Peak Concentration after morning dose (Cmax) for oral testosterone undecanoate taken after a fasting breakfast of varying fat content.
Conditions Studied
Interventions
- DRUG Oral Testosterone Undecanoate
Study Locations (2)
California
- Harbor-UCLA Medical Center - Torrance
Florida
- Orlando Clinical Research Center - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2016-10 |
| Est. Completion | 2017-01-21 |
| Phase | Phase 2 |
What the finished NCT02921386 record still lists
NCT02921386 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 119-participant average among 21 other Hypogonadism trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Hypogonadism appearing as the primary indexed condition, and to 1 intervention - of which Oral Testosterone Undecanoate is the first listed.
NCT02921386 reports a single indexed study location in California, Florida.
Frequently Asked Questions
What is clinical trial NCT02921386 about?
NCT02921386 is a clinical study titled "The Effect of Various Amounts of Fat on PK of Oral Testosterone Undecanoate". A Phase 2, open-label, randomized, cross-over, pharmacokinetic study designed to determine the effect of meals of various amounts of fat given immediately prior to dosing on the pharmacokinetics of oral testosterone undecanoate. Approximately 20 hypogonadal subjects will be dosed for a 14 day run-in...
What is the current status of trial NCT02921386?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2016-10. Estimated completion is 2017-01-21.
What conditions does trial NCT02921386 study?
This clinical trial studies the following conditions: Hypogonadism.
What interventions are being tested in trial NCT02921386?
The interventions under investigation include: Oral Testosterone Undecanoate (DRUG).
Who is sponsoring clinical trial NCT02921386?
This trial is sponsored by Clarus Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02921386 being conducted?
This trial has 2 study locations across California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hypogonadism
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02921386's enrollment target sits among peer trials
18 21st of 21 higher than 1 of 21 other Hypogonadism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypogonadism 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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