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A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel
NCT01665599 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Testosterone gel (FE 999303)
Study Locations (19)
California
- California Professional Research — Newport Beach
- San Diego Sexual Medicine — San Diego
New York
- University Urology — New York
- Premier Medical Group of the Hudson Valley — Poughkeepsie
South Carolina
- Coastal Carolina Research Center — Mt. Pleasant
- Carolina Urologic Research Center — Myrtle Beach
Ontario
- St. Joseph's Healthcare — London
- Private Practice and Clinical Research — North Bay
Alabama
- Medical Affiliated Research Cente — Huntsville
Connecticut
- Connecticut Clinical Research — Middlebury
Florida
- South Florida Medical Research — Aventura
Michigan
- Michigan Institute of Urology — Saint Clair Shores
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2012-07 |
| Est. Completion | 2013-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01665599
The ClinicalTrials.gov registry entry for NCT01665599 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ferring Pharmaceuticals, which has 27 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Adult Male Hypogonadism appearing as the primary indexed condition, and to 1 intervention — of which Testosterone gel (FE 999303) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01665599 reports 19 study locations spanning 15 distinct geographic areas — top geographies include California, New York, South Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01665599 about?
NCT01665599 is a clinical study titled "A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel". 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.
What is the current status of trial NCT01665599?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 180 participants. The study started on 2012-07. Estimated completion is 2013-05.
What conditions does trial NCT01665599 study?
This clinical trial studies the following conditions: Adult Male Hypogonadism. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01665599?
The interventions under investigation include: Testosterone gel (FE 999303) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01665599?
This trial is sponsored by Ferring Pharmaceuticals, which has 27 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01665599 being conducted?
This trial has 19 study locations across Alabama, California, Connecticut, Florida, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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