A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel
Public ClinicalTrials.gov record NCT01665599. 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.
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Official title
A Phase 3, Open-label, Non-randomized, Clinical Trial to Evaluate the Efficacy and Safety of FE 999303 (Testosterone Gel) in Adult Hypogonadal Males
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 3 clinical trial in adult hypogonadal males with baseline serum testosterone concentrations \<300 ng/dL. The purpose of this study is to evaluate the safety and efficacy of testosterone gel (2%) delivered using an applicator.
Study identification
- NCT ID
- NCT01665599
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 180 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 2012 (Type not available)
- Primary completion
- Apr 2013 (Actual)
- Completion
- May 2013 (Actual)
- Last update posted
- Oct 26, 2017
2012 – 2013
United States locations
- U.S. sites
- 17
- U.S. states
- 14
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Medical Affiliated Research Cente | Huntsville | Alabama | — | — |
| California Professional Research | Newport Beach | California | — | — |
| San Diego Sexual Medicine | San Diego | California | — | — |
| Connecticut Clinical Research | Middlebury | Connecticut | — | — |
| South Florida Medical Research | Aventura | Florida | — | — |
| Michigan Institute of Urology | Saint Clair Shores | Michigan | — | — |
| Quality Clinical Research | Omaha | Nebraska | — | — |
| Premier Urology Associates | Lawrenceville | New Jersey | — | — |
| University Urology | New York | New York | — | — |
| Premier Medical Group of the Hudson Valley | Poughkeepsie | New York | — | — |
| PMG Research of Wilmington | Winston-Salem | North Carolina | — | — |
| Tristate Urologic Services | Cincinnati | Ohio | — | — |
| Omega Medical Research | Warwick | Rhode Island | — | — |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | — | — |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | — | — |
| Clinical Research Associates | Nashville | Tennessee | — | — |
| Urology Clinics of North Texas | Dallas | Texas | — | — |
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 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01665599, 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 Oct 26, 2017 · Synced Nov 6, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01665599 live on ClinicalTrials.gov.