Safety and Efficacy of Intranasal TBS-1 Treatment of Male Hypogonadism
Public ClinicalTrials.gov record NCT01446042. 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 90-Day, Randomized, Dose-Ranging Study, Including Potential Dose Titration, Evaluating the Efficacy and Safety of Intranasal TBS-1 in the Treatment of Male Hypogonadism With Sequential Safety Extension Periods of 90 and 180 Days
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine the efficacy (based on the pharmacokinetic profile of testosterone) and safety of TBS-1 in the treatment of hypogonadal men
Study identification
- NCT ID
- NCT01446042
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 306 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 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 31, 2011
- Primary completion
- Nov 30, 2012
- Completion
- Feb 28, 2013
- Last update posted
- Jun 12, 2018
2011 – 2013
United States locations
- U.S. sites
- 30
- U.S. states
- 17
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Clinical Therapeutics LLC | Birmingham | Alabama | 35235 | — |
| Medical Affiliated Research Center, Inc. | Huntsville | Alabama | 35801 | — |
| Coastal Clinical Research | Mobile | Alabama | 36608 | — |
| Quality of Life Medical Research Center | Tucson | Arizona | 85712 | — |
| SC Clinical Research Inc | Garden Grove | California | 92844 | — |
| Diablo Clinical Reseach Inc. | Walnut Creek | California | 94598 | — |
| Innovative Research of West Florida | Clearwater | Florida | 33756 | — |
| Clinical Research of South Florida | Coral Gables | Florida | 33134 | — |
| Pharmax Research Clinic | Miami | Florida | 33126 | — |
| Compass Research East LLC | Oviedo | Florida | 32765 | — |
| Central Kentucky Research Associates | Lexington | Kentucky | 40509 | — |
| Commonwealth Biomedical Research LLC | Madisonville | Kentucky | 42431 | — |
| Regional Urology LLC | Shreveport | Louisiana | 71106 | — |
| Center for Pharmaceutical Research | Kansas City | Missouri | 61114 | — |
| Clinical Research Center of Nevada | Las Vegas | Nevada | 89104 | — |
| Rochester Clinical Research | Rochester | New York | 14609 | — |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | — |
| The Clinical Trial Center | Jenkintown | Pennsylvania | 19046 | — |
| Omega Medical Research | Warwick | Rhode Island | 02886 | — |
| Coastal Carolina Research Center Inc | Mt. Pleasant | South Carolina | 29464 | — |
| Austin Center for Clinical Research | Austin | Texas | 78756 | — |
| Reseach Across America | Dallas | Texas | 75234 | — |
| Centex Research | Houston | Texas | 77062 | — |
| Clinical Trial Network | Houston | Texas | 77074 | — |
| Cetero Research | San Antonio | Texas | 78229 | — |
| Granger Medical Clinic | West Valley City | Utah | 84120 | — |
| National Clinical Research - Norfolk | Norfolk | Virginia | 23502 | — |
| National Clinical Research | Richmond | Virginia | 23294 | — |
| Capital Clinical Reseach Center | Olympia | Washington | 98502 | — |
| Rainier Clinical Research Center | Renton | Washington | 98057 | — |
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 NCT01446042, 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 12, 2018 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01446042 live on ClinicalTrials.gov.