Efficacy Study for Use of Dutasteride (Avodart) With Testosterone Replacement
Status:
Completed
Trial end date:
2012-03-01
Target enrollment:
Participant gender:
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.