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Pilot Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men

NCT02697188 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-11-01

Study results available
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Summary

Determine the serum pharmacokinetic profile for two oral formulations of T-esters (one TE and one TU) administered once -(QD) and twice-daily (BID) to hypogonadal men.

Conditions

  • Hypogonadism

Interventions

DRUG

Testosterone undecanoate

Single-day dose as QD or BID for 3 of 5 crossover periods

DRUG

Testosterone enanthate

Single-day dose for 2 of 5 crossover periods

Sponsors & Collaborators

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    collaborator OTHER

  • Clarus Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Ronald S Swerdloff, MD · Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  • Sherwyn Schwartz, MD · dgd Research, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-04-30
Completion
2008-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02697188 on ClinicalTrials.gov