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NCT00752869 · ClinicalTrials.gov registry record · Phase 4
Efficacy Study for Use of Dutasteride (Avodart) With Testosterone Replacement
A Phase 4 study of Hypogonadism, sponsored by The Miriam Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 24
- Enrollment target
- 2
- Study locations
NCT00752869: Completed Phase 4 study of Hypogonadism, sponsored by The Miriam Hospital.
NCT00752869 is a Phase 4 study of Hypogonadism that has completed, run by The Miriam Hospital. The registered enrollment target is 24 participants, below the 119-participant average among 21 other Hypogonadism trials with a reported enrollment target (80% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00752869, a Phase 4 study of Hypogonadism, has completed, sponsored by The Miriam Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 24 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a study using two FDA approved medications: Testosterone and the study medication, Dutasteride (Avodart 0.5mg/day). Half of the subjects will receive dutasteride and half will receive a placebo. The study medication will be taken for 12 months. The subjects participating in the study are men who are already taking their own testosterone supplement because they have low testosterone levels which may cause them to experience sexual function difficulties, have fatigue or other symptoms. Testosterone can have an adverse effect of causing an enlarged prostate (Benign Prostatic Hypertrophy) (BPH). Dutasteride (Avodart) is an approved medication used to decrease the prostate size, prevent urinary symptoms and reduce the risk of surgery. The researchers would like to see if by taking dutasteride and testosterone at the same time they can prevent the adverse effects of testosterone and at the same time get the positive benefits of testosterone. There will be 6 scheduled visits for the study and 2 diagnostic tests called a TRUS (TransRectal UltraSound), to evaluate prostate size. The six visits at will include consenting, blood work, two sexual function questionnaires, a physical examination, physical measurements, study medication teaching and dispensing of study medication.
Conditions Studied
Interventions
- DRUG placebo
- DRUG dutasteride
Study Locations (2)
Massachusetts
- Men's Health Boston - Boston
Rhode Island
- The Miriam Hospital - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2008-09 |
| Est. Completion | 2012-03 |
| Phase | Phase 4 |
What the finished NCT00752869 record still lists
NCT00752869 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 119-participant average among 21 other Hypogonadism trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Hypogonadism appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00752869 reports a single indexed study location in Massachusetts, Rhode Island.
Frequently Asked Questions
What is clinical trial NCT00752869 about?
NCT00752869 is a clinical study titled "Efficacy Study for Use of Dutasteride (Avodart) With Testosterone Replacement". This is a study using two FDA approved medications: Testosterone and the study medication, Dutasteride (Avodart 0.5mg/day). Half of the subjects will receive dutasteride and half will receive a placebo. The study medication will be taken for 12 months. The subjects participating in the study are me...
What is the current status of trial NCT00752869?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2008-09. Estimated completion is 2012-03.
What conditions does trial NCT00752869 study?
This clinical trial studies the following conditions: Hypogonadism.
What interventions are being tested in trial NCT00752869?
The interventions under investigation include: placebo (DRUG), dutasteride (DRUG).
Who is sponsoring clinical trial NCT00752869?
This trial is sponsored by The Miriam Hospital, which has 136 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00752869 being conducted?
This trial has 2 study locations across Massachusetts, Rhode Island. 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 NCT00752869's enrollment target sits among peer trials
24 18th of 21 higher than 3 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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