Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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 |
Interested in This 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, categorized as Phase 2. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 118-participant average among 21 other Hypogonadism trials with a reported enrollment target (64% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
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 reports 7 study locations spanning 6 distinct geographic areas - top geographies include 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.
-
Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury
RECRUITING · Phase 2
-
A Preliminary Clinical Study to Evaluate Fispemifene in the Treatment of Hypogonadism
COMPLETED · Phase 2
-
Pharmacokinetics, Metabolism, Efficacy, and Safety Study of Two Testosterone Matrix Transdermal Systems
COMPLETED · Phase 2
-
Testosterone and Growth Hormone for Bone Loss in Men
COMPLETED · Phase 2
-
The Effect of Various Amounts of Fat on PK of Oral Testosterone Undecanoate
COMPLETED · Phase 2
-
Observation of Environment and Reproductive-Endocrine Effects
RECRUITING
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.