Efficacy Study for Use of Dutasteride (Avodart) With Testosterone Replacement (NCT00752869) | Clinical Trial Compass
CompletedPhase 4
Efficacy Study for Use of Dutasteride (Avodart) With Testosterone Replacement
United States24 participantsStarted 2008-09
Plain-language 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.
Who can participate
Age range
40 Years – 85 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects currently on stable testosterone replacement therapy for 3 months' duration using either the approved transdermal products Androgel® or Testim®, or injections of testosterone enanthate or cypionate with a morning serum testosterone concentration within the normal range (300 - 1000 ng/dl). These will dispensed either by prescription or for injections by the PI or co-PI in the office.
. Total Serum PSA \>1.5 - 10 ng/mL
. Subject is able to read and comprehend the informed consent document.
. If the subject is on current replacement therapy for hypopituitarism or other multiple endocrine abnormalities, the subject must be on stable doses of thyroid hormone and/or adrenal replacement hormones for at least 14 days prior to enrollment.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Use of medications including those interactive with dutasteride from prior studies
. Hematocrit greater than 51%
. Prostate cancer in men found to have a prostate nodule on initial exam and subsequent positive biopsy
. No prostate surgery within 2 months of entry
. No prior use of finasteride, dutasteride within 6 months prior
. A history of hepatic impairment or abnormal liver function tests (defined as ALT, AST, alkaline phosphatase or bilirubin \>1.5 times the upper limit of normal) with the exception that bilirubin elevations up to 2.0 times the upper limit of normal in the presence of normal liver enzymes will be permitted in patients with documented Gilbert's Disease. Subjects with Gilbert's disease not to be excluded.
. No serum creatinine greater than 2.0 times upper limit of normal