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 range40 Years – 85 Years
SexMALE
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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
✕. 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 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
✕. No history of alcohol abuse with last 12 months