Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02921386
The ClinicalTrials.gov registry entry for NCT02921386 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 119-participant average among 21 other Hypogonadism trials with a reported enrollment target (85% lower). The listed sponsor is Clarus Therapeutics, which has 11 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.
-
Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury
RECRUITING · Phase 2
-
A Preliminary Clinical Study to Evaluate Fispemifene in the Treatment of Hypogonadism
COMPLETED · Phase 2
-
Pharmacokinetics, Metabolism, Efficacy, and Safety Study of Two Testosterone Matrix Transdermal Systems
COMPLETED · Phase 2
-
Testosterone and Growth Hormone for Bone Loss in Men
COMPLETED · Phase 2
-
28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men
COMPLETED · Phase 2
-
Observation of Environment and Reproductive-Endocrine Effects
RECRUITING
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.