MedTrace Logo

Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men

NCT01699178 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2021-06-28

Study results available
· View outcomes & findings →

Summary

The purpose of this one year extension (follow-up) study is to gather additional safety data in hypogonadal men treated with oral TU or AndroGel who have completed the 12-month Phase III study CLAR-09007.

Conditions

  • Male Hypogonadism

Interventions

DRUG

Oral testosterone undecanoate

Total daily dose of T = 200 mg T (as 316 mg TU) to 600 mg T (as 948 mg TU), taken as 100 mg to 300 mg T BID

DRUG

Transdermal testosterone gel (AndroGel)

Total daily dose of T = 2.5 to 10 g of gel (25 mg to 100 mg T) QD

Sponsors & Collaborators

  • Clarus Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Ronald Swerdloff, MD · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States
  • Germany

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 NCT01699178 on ClinicalTrials.gov