Efficacy Study for Use of Dutasteride (Avodart) With Testosterone Replacement (DUT/T)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Dutasteride in Men Receiving Testosterone Therapy: Impact on Serum PSA, Testosterone, DHT Levels and Prostate Volume: "Implications for Prostate Safety"|
- PSA reduction [ Time Frame: with up to 12 months of treatment ] [ Designated as safety issue: Yes ]
- PV reduction with up to 12 months of treatment [ Time Frame: 1 year treatment ] [ Designated as safety issue: Yes ]
- DHT and T levels: serum [ Time Frame: 1 year treatment ] [ Designated as safety issue: Yes ]
- Prostatic TRUS pre and post treatment [ Time Frame: 1 year treatment ] [ Designated as safety issue: Yes ]
- IIEF; MHSQ: Questionnaires examining the domains of erectile and orgasmic function in men in the two treatment arms [ Time Frame: 1 year treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2008|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Placebo Comparator: B
This group will meet the same inclusion and exclusion criteria as the group receiving the study drug
one tablet per day for 1 year
Other Name: Inactive substance
Active Comparator: A
This arm will receive the active medication dutasteride
0.5mg by mouth one time per day for 1 year
- Serum AST or ALT > 3 times ULN
Total serum bilirubin > 1.5 times ULN
- no study termination of a patient with documented Gilberts disease for an isolated bilirubin elevation unless it exceeds 2.5x the upper limit of normal.
- Hematocrit > 55%
- Subject experiences any unacceptable or intolerable adverse effect.
- Subject is non-compliant with the study protocol.
- Subject needs to take any medication that would interfere with study measurements
- Subject develops prostate or breast cancer
|United States, Massachusetts|
|Men's Health Boston|
|Boston, Massachusetts, United States, 002445|
|United States, Rhode Island|
|The Miriam Hospital|
|Providence, Rhode Island, United States, 02906|
|Principal Investigator:||Martin M Miner, MD||The Miriam Hospital|
|Principal Investigator:||Abraham Morgentaler, MD||Men's Health Boston|