Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
Public ClinicalTrials.gov record NCT01403116. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 3, Active-Controlled, Safety and Efficacy Trial 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 study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.
Study identification
- NCT ID
- NCT01403116
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 325 participants
Conditions and interventions
Conditions
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
- Jul 2011 (Type not available)
- Primary completion
- Sep 2013 (Actual)
- Completion
- Sep 2013 (Actual)
- Last update posted
- Aug 14, 2018
2011 – 2013
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 Affliated 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 | 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, MD, PC | 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 NCT01403116, 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 Aug 14, 2018 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01403116 live on ClinicalTrials.gov.