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NCT00398580 · ClinicalTrials.gov registry record · Phase 2
28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men
A Phase 2 study of Hypogonadism and Hypogonadism, Male, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
- 7
- Study locations
NCT00398580: Completed Phase 2 study of Hypogonadism and Hypogonadism, Male, sponsored by GlaxoSmithKline.
NCT00398580 is a Phase 2 study of Hypogonadism and Hypogonadism, Male that has completed, run by GlaxoSmithKline. The registered enrollment target is 43 participants, below the 118-participant average among 21 other Hypogonadism trials with a reported enrollment target (64% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00398580, a Phase 2 study of Hypogonadism and Hypogonadism, Male, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
- 7
- Study locations
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 |
What the finished NCT00398580 record still lists
NCT00398580 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 118-participant average among 21 other Hypogonadism trials with a reported enrollment target (64% lower).
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.
NCT00398580 lists 7 locations in 6 states (Washington, California, Kentucky).
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.
What interventions are being tested in trial NCT00398580?
The interventions under investigation include: Nanomilled testosterone (DRUG), Nanomilled dutasteride (DRUG), commercially available dutasteride (DRUG).
Who is sponsoring clinical trial NCT00398580?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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
Similar trials for Hypogonadism
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00398580's enrollment target sits among peer trials
43 13th of 21 higher than 9 of 21 other Hypogonadism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypogonadism trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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