Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men
NCT00398580 · View on ClinicalTrials.gov ↗
Study Summary
The combination of testosterone and dutasteride is intended for use in hypogonadal men. This study will evaluate the effect of 28-day repeat dosing of this combination with varying BID doses of testosterone (T), in combination with a fixed BID dose of dutasteride (D), as well as a testosterone alone arm, on T and D levels in the blood. The rationale is to look for the effects of each compound on the other, and to look for any safety problems that may result when the 2 drugs are given together.
Conditions Studied
Interventions
- DRUG Nanomilled testosterone
- DRUG Nanomilled dutasteride
- DRUG commercially available dutasteride
Study Locations (7)
Washington
- GSK Investigational Site — Seattle
- GSK Investigational Site — Seattle
California
- GSK Investigational Site — Torrance
Kentucky
- GSK Investigational Site — Louisville
Maryland
- GSK Investigational Site — Baltimore
North Carolina
- GSK Investigational Site — Durham
Texas
- GSK Investigational Site — San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2006-10 |
| Est. Completion | 2007-10 |
| Phase | Phase 2 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00398580
The ClinicalTrials.gov registry entry for NCT00398580 describes a study currently listed as completed. It is categorized as Phase 2, 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 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Hypogonadism appearing as the primary indexed condition, and to 3 interventions — of which Nanomilled testosterone 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: NCT00398580 reports 7 study locations spanning 6 distinct geographic areas — top geographies include Washington, California, Kentucky. 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 NCT00398580 about?
NCT00398580 is a clinical study titled "28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men". The combination of testosterone and dutasteride is intended for use in hypogonadal men. This study will evaluate the effect of 28-day repeat dosing of this combination with varying BID doses of testosterone (T), in combination with a fixed BID dose of dutasteride (D), as well as a testosterone alone...
What is the current status of trial NCT00398580?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2006-10. Estimated completion is 2007-10.
What conditions does trial NCT00398580 study?
This clinical trial studies the following conditions: Hypogonadism, Hypogonadism, Male. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00398580?
The interventions under investigation include: Nanomilled testosterone (DRUG), Nanomilled dutasteride (DRUG), commercially available dutasteride (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00398580?
This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00398580 being conducted?
This trial has 7 study locations across California, Kentucky, Maryland, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.