28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men
Public ClinicalTrials.gov record NCT00398580. 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 Phase II, 28-Day, Randomized, Parallel-Group, Open-Label Study Evaluating the Efficacy and Safety of Twice Daily Oral Doses of Testosterone (150-400mg) Co-administered With 0.25mg Dutasteride Compared With 400mg Testosterone Alone and 0.25mg Dutasteride Alone in the Treatment of Hypogonadism
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00398580
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 43 participants
Conditions and interventions
Conditions
Interventions
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 70 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
- Oct 2006 (Type not available)
- Primary completion
- Oct 2007 (Actual)
- Completion
- Oct 2007 (Actual)
- Last update posted
- May 30, 2017
2006 – 2007
United States locations
- U.S. sites
- 7
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Torrance | California | 90502 | — |
| GSK Investigational Site | Louisville | Kentucky | 40202 | — |
| GSK Investigational Site | Baltimore | Maryland | 21287 | — |
| GSK Investigational Site | Durham | North Carolina | 27710 | — |
| GSK Investigational Site | San Antonio | Texas | 78229 | — |
| GSK Investigational Site | Seattle | Washington | 98108 | — |
| GSK Investigational Site | Seattle | Washington | 98195 | — |
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 NCT00398580, 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 May 30, 2017 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00398580 live on ClinicalTrials.gov.