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NCT00802321 · ClinicalTrials.gov registry record · NA
Pharmacokinetic Study of Single Dose Dutasteride in Healthy Subjects
A NA study of Alcoholism and Alcohol Abuse, sponsored by UConn Health.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT00802321 is a NA study of Alcoholism and Alcohol Abuse that has completed, run by UConn Health. The registered enrollment target is 40 participants, below the 374-participant average among 65 other Alcoholism trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00802321, a NA study of Alcoholism and Alcohol Abuse, has completed, sponsored by UConn Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
To monitor the inhibition of 5a-reductase (5AR) enzyme activity at 1, 3, 7, 14, 21, 28 and 42 days following administration of a single dose of dutasteride (2, 3, or 4 mg) by measuring the change in blood levels of 3a-androstanediol glucuronide (3a-diolG) and the ratio of dihydrotestosterone (DHT) to testosterone. To accomplish this aim, an open-label, between-subjects dose comparison study design will be employed with subjects receiving a 2, 3, or 4 mg dosage. Subjects (up to n=40 enrolled to allow a minimum of 24 completers) will be randomly assigned to one of the 3 dose levels. Results of this study will inform the dose selection for a subsequent placebo-controlled, within-subject, crossover study of dutasteride on the effects of alcohol. A secondary aim of this study is to examine the correlation of a genetic variation in the type I 5AR gene and baseline DHT/T ratio and effect of dutasteride at day 3. A variation in this gene which is one of the targets of dutasteride has been reported to be associated with higher baseline levels of DHT.
Conditions Studied
Interventions
- DRUG Dutasteride
Study Locations (1)
Connecticut
- Unversity of Connecticut Health Center - Farmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2006-04 |
| Est. Completion | 2006-11 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00802321
The ClinicalTrials.gov registry entry for NCT00802321 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 374-participant average among 65 other Alcoholism trials with a reported enrollment target (89% lower). The listed sponsor is UConn Health, which has 178 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Alcoholism appearing as the primary indexed condition, and to 1 intervention - of which Dutasteride is the first listed.
NCT00802321 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.
Frequently Asked Questions
What is clinical trial NCT00802321 about?
NCT00802321 is a clinical study titled "Pharmacokinetic Study of Single Dose Dutasteride in Healthy Subjects". To monitor the inhibition of 5a-reductase (5AR) enzyme activity at 1, 3, 7, 14, 21, 28 and 42 days following administration of a single dose of dutasteride (2, 3, or 4 mg) by measuring the change in blood levels of 3a-androstanediol glucuronide (3a-diolG) and the ratio of dihydrotestosterone (DHT) t...
What is the current status of trial NCT00802321?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2006-04. Estimated completion is 2006-11.
What conditions does trial NCT00802321 study?
This clinical trial studies the following conditions: Alcoholism, Alcohol Abuse, Alcohol-Related Disorders.
What interventions are being tested in trial NCT00802321?
The interventions under investigation include: Dutasteride (DRUG).
Who is sponsoring clinical trial NCT00802321?
This trial is sponsored by UConn Health, which has 178 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00802321 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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