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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01699178

Public ClinicalTrials.gov record NCT01699178. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 2:59 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Open-Label Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01699178
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Clarus Therapeutics, Inc.
Industry
Enrollment
182 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 2012 (Type not available)
Primary completion
Apr 2014 (Actual)
Completion
Apr 2014 (Actual)
Last update posted
Jun 28, 2021

2012 – 2014

United States locations

U.S. sites
25
U.S. states
13
U.S. cities
23
Facility City State ZIP Site status
Alabama Clinical Therapeutics, Inc. Birmingham Alabama 35235 —
Alabama Internal Medicine, PC Birmingham Alabama 35235 —
Alabama Clinical Therapeutics Calera Alabama 35040 —
Medical Affiliated Research Center, Inc Huntsville Alabama 35801 —
Quality of Life Medical and Research Centers, LLC Tucson Arizona 85712 —
Providence Clinical Research Burbank California 91505 —
South Orange County Endocrinology Laguna Hills California 92653 —
Tower Urology Los Angeles California 90048 —
David Geffen School of Medicine, UCLA Los Angeles California 90095 —
Harbor-UCLA Medical Center, LA Biomedical Research Institute Torrance California 90502 —
Connecticut Clinical Research Center/ConnecTrials Middlebury Connecticut 06762 —
University of CT School of Medicine New Haven Connecticut 06511 —
South Florida Medical Research Aventura Florida 33180 —
University of Louisville Louisville Kentucky 40202 —
Johns Hopkins University Baltimore Maryland 21287 —
Boston University School of Medicine Boston Massachusetts 02118 —
Maimonides Medical Center Brooklyn New York 11235 —
Bruce R. Gilbert, MD, PhD Great Neck New York 11021 —
University Urology Associates New York New York 10016 —
Michael A. Werner Purchase New York 10577 —
Sunstone Medical Research Medford Oregon 97504 —
Urologic Consultants of Southeast Pennsylvania Bala-Cynwyd Pennsylvania 19004 —
Research Across America Carrollton Texas 75010 —
Research Across America Dallas Texas 75234 —
University of Washington Seattle Washington 98195 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01699178, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 28, 2021 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01699178 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →