Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men
Public ClinicalTrials.gov record NCT03198728. 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
A 12-Month, Randomized, Active-controlled, Open-label Study of the Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men (RE-TUne)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This will be a randomized, multicenter, open-label, active-controlled, efficacy, and safety study in adult hypogonadal men. The study duration is 12 months (365 days), including a 90-day, open-label efficacy period and a 9-month (275-day) safety evaluation period.
Study identification
- NCT ID
- NCT03198728
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 314 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 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 4, 2017
- Primary completion
- Apr 30, 2020
- Completion
- Apr 30, 2020
- Last update posted
- Jun 27, 2023
2017 – 2020
United States locations
- U.S. sites
- 36
- U.S. states
- 21
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Central Research Associates, Inc. | Birmingham | Alabama | 35205 | — |
| Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | 35235 | — |
| Coastal Clinical Research, Inc. | Mobile | Alabama | 36608 | — |
| Quality of Life Medical and Research Centers, LLC | Tucson | Arizona | 85712 | — |
| San Diego Sexual Medicine | San Diego | California | 92120 | — |
| South Florida Medical Research | Aventura | Florida | 33180 | — |
| PAB Clinical Research | Brandon | Florida | 33511 | — |
| Innovative Research of West Florida, Inc. | Clearwater | Florida | 33756 | — |
| Jacksonville Impotence Treatment Center | Jacksonville | Florida | 32223 | — |
| Health Awareness, Inc. | Jupiter | Florida | 33458 | — |
| Meridien Research | Lakeland | Florida | 33805 | — |
| My Community Research Center | Miami | Florida | 33155 | — |
| Oviedo Medical Research, LLC | Oviedo | Florida | 32765 | — |
| Meridien Research | St. Petersburg | Florida | 33709 | — |
| Primary Care Research Group | Atlanta | Georgia | 30312 | — |
| Northwest Clinical Trials | Boise | Idaho | 83704 | — |
| Advanced Clinical Research | Meridian | Idaho | 83642 | — |
| Central Kentucky Research Associates | Lexington | Kentucky | 40509 | — |
| Centex Studies, Inc. | Lake Charles | Louisiana | 70601 | — |
| Men's Health Boston | Chestnut Hill | Massachusetts | 02467 | — |
| Quality Clinical Research, Inc. | Omaha | Nebraska | 68114 | — |
| Palm Research Center, Inc. | Las Vegas | Nevada | 89148 | — |
| Accumed Research Associates | Garden City | New York | 11530 | — |
| Manhattan Medical Research Practice, PLLC | New York | New York | 10016 | — |
| Rapha Institute For Clinical Research | Fayetteville | North Carolina | 28314 | — |
| Aventiv Research, Inc. | Columbus | Ohio | 43213 | — |
| Urologic Consultants of SE Pennsylvania | Bala-Cynwyd | Pennsylvania | 19004 | — |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | — |
| University Diabetes Endocrine Consultants | Chattanooga | Tennessee | 37411 | — |
| Centex Studies, Inc. | Houston | Texas | 77058 | — |
| Pioneer Research Solutions, Inc. | Houston | Texas | 77099 | — |
| Advanced Clinical Research | West Jordan | Utah | 84088 | — |
| Clinical Research Associates of Tidewater | Norfolk | Virginia | 23507 | — |
| National Clinical Research, Inc. | Richmond | Virginia | 23294 | — |
| Rainier Clinical Research Center, Inc. | Renton | Washington | 98057 | — |
| Mid-Columbia Research | Richland | Washington | 99352 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03198728, 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 27, 2023 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03198728 live on ClinicalTrials.gov.