MedTrace Logo

Phlebotomy Study of Testosterone Undecanoate

NCT02670343 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2018-03-09

Study results available
· View outcomes & findings →

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.

Conditions

  • Hypogonadism

Interventions

DRUG

Oral Testosterone Undecanoate

Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone.

Sponsors & Collaborators

  • Clarus Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Christina Wang, M.D. · Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02670343 on ClinicalTrials.gov