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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 is a Phase 1 study that has completed, run by Clarus Therapeutics. The registered enrollment target is 8 participants.

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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.

Interventions

  • DRUG Oral Testosterone Undecanoate

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2016-01
Est. Completion 2016-03
Phase Phase 1

Sponsor

Clarus Therapeutics

11 total trials

What the Registry Record Tells You About NCT02670343

The ClinicalTrials.gov registry entry for NCT02670343 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Clarus Therapeutics, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Oral Testosterone Undecanoate is the first listed.

NCT02670343 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.