Hypogonadism, Benign Prostatic Hyperplasia
Conditions
Keywords
androgen deficiency, testosterone, Benign Prostatic Hyperplasia, hypogonadism, prostate, BPH
Brief summary
The purpose of this research study is to determine whether the combination of the male hormone testosterone \[T\] in gel form and the oral drug dutasteride \[D\], used to shrink large prostate glands can safely reduce the size of the prostate gland and symptoms of prostate enlargement (called benign prostatic hyperplasia \[BPH\]) compared to T treatment alone in men with low testosterone (called hypogonadism).
Detailed description
The primary aim of this study is to determine whether correction of hypogonadism using a combination of testosterone and dutasteride spares subjects from increases in prostate size and symptoms of BPH which may be associated with T alone. We will also determine the effects of changes in serum T and dihydrotestosterone (DHT) on both the hormonal milieu and genetic program within the prostate gland itself. The technology employed will allow us to determine which genes are androgen responsive within each prostate tissue compartment. Together, these data may determine whether the combination of testosterone and dutasteride safely corrects the symptoms of BPH and hypogonadism and minimizes growth stimulus to the prostate at the genetic level. We will also assess the effects of the combination of T and dutasteride on cognitive function. This is a six-month, double-blind, randomized, placebo-controlled, single-site study of older hypogonadal men with mild to moderate BPH. Within each treatment group, a sub-group of subjects will undergo additional procedures as part of a Prostate Biopsy sub-study to obtain prostate tissue for hormonal and genetic analyses. Selection of subjects will be based on clinical indication and/or willingness to undergo prostate biopsies.
Interventions
DRUGDutasteride
Dutasteride 0.5 mg orally daily
DRUGTestosterone gel
Testosterone gel 7.5 g daily topical
placebo dutasteride orally daily
Sponsors
GlaxoSmithKline
Seattle Institute for Biomedical and Clinical Research
VA Office of Research and Development
Solvay Pharmaceuticals
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Generally healthy older men 50 years old or older * Hypogonadism; low testosterone (total T less than 280 ng/dL on one occasion or an average of equal to or less than 300 ng/dl on two occasions) * Prostate volume equal to or more than 30 cc by prostate MRI * Prostate Specific Antigen (PSA) equal to or more than 1.5 ng/mL and equal to or less than 10 ng/mL * Subjects with a PSA greater than 4.0 ng/ml must have a negative prostate biopsy * International Prostate Symptom Score (IPSS) greater than or equal to 8 and less than or equal to 20 at screening * Comply with study procedures for the full 10 months * No contraindications to MRI Subjects with symptomatic Benign Prostatic Hyperplasia (BPH) will be recruited from the Urology and General Internal Medicine Clinics at the VA Puget Sound Health Care System and University of Washington Medical Center in Seattle.
Exclusion criteria
* A history of prostate or breast cancer * Invasive therapy for BPH in the past * History of acute urinary retention in the 3 months prior to screening * Previous treatment with a 5 alpha-reductase inhibitor (finasteride or dutasteride) * Medical therapy for BPH within the past month (alpha-blocker, phytotherapy) * Use of androgenic or antiandrogenic drugs in the past year * History or evidence of prostate cancer including suspicious DRE or history of high-grade PIN on prostate biopsy. * Severe systemic illness (renal, liver, cardiac, lung disease, cancer, diabetes) * Known untreated obstructive sleep apnea * Hematocrit greater than 52 * Severe skin disease which may interfere with testosterone gel absorption * Hypersensitivity to any of the drugs used in the study * History of a bleeding disorder or need for chronic anticoagulation * Participation in a drug study concurrently or in the last 90 days * History or current evidence of drug or alcohol abuse within 12 mo. * Weight more than 300 lbs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effects of Testosterone Gel Alone or in Combination With Oral Dutasteride on Prostate Volume in Hypogonadal Men With Benign Prostatic Hyperplasia. | Baseline, Month 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum and Intraprostatic Hormone Levels: Prostate Specific Antigen (PSA) | Baseline, Month 6 | — |
| The Effects of T Alone or in Combination With Dutasteride on Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men With Benign Prostatic Hyperplasia. (International Prostate Symptom Score) | Baseline, Month 3, Month 6 | International Prostate Symptom Score to assess lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Minimum score = 0, maximum score = 35; mildly symptomatic score = 0-7; moderately symptomatic score = 8-19; severely symptomatic score = 20-35; no subscales. |
| Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men (Uroflow) | Baseline, 3-months, 6-months | — |
| Signs and Symptoms Benign Prostatic Hyperplasia (BPH): Post-voiding Residual (PVR) Urinary Volume | Baseline, 3-months, 6-months | — |
| Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Baseline, 3-months, 6-months | — |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from the VA Puget Sound Health Care System, Seattle, WA. 102 men were screened and 53 were randomized.
Pre-assignment details
49 were excluded. 4 withdrew consent, 3 lost to follow-up, 42 for inclusion/exclusion criteria: 3 could not tolerate MRI, 3 were previously on testosterone therapy, 21 had prostate volume \<30cc, 12 had repeat serum testosterone \>280 ng/mL, and 3 had prostate cancer or prostate intraepithelial neoplasia at pre-treatment prostate biopsy.
Participants by arm
| Arm | Count |
|---|---|
| Testosterone Gel + Oral Placebo Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months | 27 |
| Testosterone Gel + Oral Dutasteride Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months | 26 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | lack of interest | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | withdrew due to edgy feeling | 1 | 0 |
Baseline characteristics
| Characteristic | Testosterone Gel + Oral Placebo | Testosterone Gel + Oral Dutasteride | Total |
|---|---|---|---|
| Age, Customized Between 50 and 82 years | 63.5 participants STANDARD_DEVIATION 8 | 63.6 participants STANDARD_DEVIATION 5.5 | 63.55 participants STANDARD_DEVIATION 6.8 |
| Region of Enrollment United States | 27 participants | 26 participants | 53 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 27 Participants | 26 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 27 | 4 / 26 |
| serious Total, serious adverse events | 2 / 27 | 0 / 26 |
Outcome results
Primary
Effects of Testosterone Gel Alone or in Combination With Oral Dutasteride on Prostate Volume in Hypogonadal Men With Benign Prostatic Hyperplasia.
Time frame: Baseline, Month 6
Population: per protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Testosterone Gel + Oral Placebo | Effects of Testosterone Gel Alone or in Combination With Oral Dutasteride on Prostate Volume in Hypogonadal Men With Benign Prostatic Hyperplasia. | Baseline, Day 0 | 54.2 cubic centimeters | Standard Deviation 38.1 |
| Testosterone Gel + Oral Placebo | Effects of Testosterone Gel Alone or in Combination With Oral Dutasteride on Prostate Volume in Hypogonadal Men With Benign Prostatic Hyperplasia. | Month 6 | 58.3 cubic centimeters | Standard Deviation 38.7 |
| Testosterone Gel + Oral Dutasteride | Effects of Testosterone Gel Alone or in Combination With Oral Dutasteride on Prostate Volume in Hypogonadal Men With Benign Prostatic Hyperplasia. | Baseline, Day 0 | 44.4 cubic centimeters | Standard Deviation 19.8 |
| Testosterone Gel + Oral Dutasteride | Effects of Testosterone Gel Alone or in Combination With Oral Dutasteride on Prostate Volume in Hypogonadal Men With Benign Prostatic Hyperplasia. | Month 6 | 38.6 cubic centimeters | Standard Deviation 18.4 |
Secondary
Serum and Intraprostatic Hormone Levels: Prostate Specific Antigen (PSA)
Time frame: Baseline, Month 6
Population: per protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Testosterone Gel + Oral Placebo | Serum and Intraprostatic Hormone Levels: Prostate Specific Antigen (PSA) | Baseline PSA | 2.8 ng/ ml | Standard Deviation 2.9 |
| Testosterone Gel + Oral Placebo | Serum and Intraprostatic Hormone Levels: Prostate Specific Antigen (PSA) | Month 6 PSA | 3.1 ng/ ml | Standard Deviation 2.9 |
| Testosterone Gel + Oral Dutasteride | Serum and Intraprostatic Hormone Levels: Prostate Specific Antigen (PSA) | Baseline PSA | 2.1 ng/ ml | Standard Deviation 1.3 |
| Testosterone Gel + Oral Dutasteride | Serum and Intraprostatic Hormone Levels: Prostate Specific Antigen (PSA) | Month 6 PSA | 1.4 ng/ ml | Standard Deviation 1.2 |
Secondary
Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione.
Time frame: Baseline, 3-months, 6-months
Population: per protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Testosterone Gel + Oral Placebo | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Androstenedione, month 6 | 100 ng/ dL | Standard Deviation 57 |
| Testosterone Gel + Oral Placebo | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Total testosterone, baseline | 206 ng/ dL | Standard Deviation 109 |
| Testosterone Gel + Oral Placebo | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Total testosterone, month 3 | 494 ng/ dL | Standard Deviation 331 |
| Testosterone Gel + Oral Placebo | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Total testosterone, month 6 | 481 ng/ dL | Standard Deviation 329 |
| Testosterone Gel + Oral Placebo | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Free testosterone, baseline | 4.2 ng/ dL | Standard Deviation 2 |
| Testosterone Gel + Oral Placebo | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Free testosterone, month 3 | 11.3 ng/ dL | Standard Deviation 6.8 |
| Testosterone Gel + Oral Placebo | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Free testosterone, month 6 | 11.4 ng/ dL | Standard Deviation 11.1 |
| Testosterone Gel + Oral Placebo | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Dihydrotestosterone (DHT), baseline | 47 ng/ dL | Standard Deviation 94 |
| Testosterone Gel + Oral Placebo | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Dihydrotestosterone (DHT), month 3 | 145 ng/ dL | Standard Deviation 120 |
| Testosterone Gel + Oral Placebo | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Dihydrotestosterone (DHT), month 6 | 134 ng/ dL | Standard Deviation 87 |
| Testosterone Gel + Oral Placebo | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Dehydroepiandrosterone (DHEA), baseline | 72 ng/ dL | Standard Deviation 42 |
| Testosterone Gel + Oral Placebo | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Dehydroepiandrosterone (DHEA), month 3 | 98 ng/ dL | Standard Deviation 92 |
| Testosterone Gel + Oral Placebo | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Dehydroepiandrosterone (DHEA), month 6 | 97 ng/ dL | Standard Deviation 86 |
| Testosterone Gel + Oral Placebo | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Androstenedione, baseline | 45 ng/ dL | Standard Deviation 21 |
| Testosterone Gel + Oral Placebo | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Androstenedione, month 3 | 99 ng/ dL | Standard Deviation 72 |
| Testosterone Gel + Oral Dutasteride | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Androstenedione, month 6 | 123 ng/ dL | Standard Deviation 61 |
| Testosterone Gel + Oral Dutasteride | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Dihydrotestosterone (DHT), month 3 | 16 ng/ dL | Standard Deviation 11 |
| Testosterone Gel + Oral Dutasteride | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Total testosterone, baseline | 213 ng/ dL | Standard Deviation 68 |
| Testosterone Gel + Oral Dutasteride | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Dehydroepiandrosterone (DHEA), month 6 | 111 ng/ dL | Standard Deviation 90 |
| Testosterone Gel + Oral Dutasteride | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Total testosterone, month 3 | 525 ng/ dL | Standard Deviation 268 |
| Testosterone Gel + Oral Dutasteride | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Dihydrotestosterone (DHT), month 6 | 12 ng/ dL | Standard Deviation 7 |
| Testosterone Gel + Oral Dutasteride | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Total testosterone, month 6 | 534 ng/ dL | Standard Deviation 360 |
| Testosterone Gel + Oral Dutasteride | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Androstenedione, month 3 | 140 ng/ dL | Standard Deviation 60 |
| Testosterone Gel + Oral Dutasteride | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Free testosterone, baseline | 4.5 ng/ dL | Standard Deviation 1.8 |
| Testosterone Gel + Oral Dutasteride | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Dehydroepiandrosterone (DHEA), baseline | 99 ng/ dL | Standard Deviation 68 |
| Testosterone Gel + Oral Dutasteride | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Free testosterone, month 3 | 12.0 ng/ dL | Standard Deviation 6.1 |
| Testosterone Gel + Oral Dutasteride | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Androstenedione, baseline | 47 ng/ dL | Standard Deviation 28 |
| Testosterone Gel + Oral Dutasteride | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Free testosterone, month 6 | 12.3 ng/ dL | Standard Deviation 9.6 |
| Testosterone Gel + Oral Dutasteride | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Dehydroepiandrosterone (DHEA), month 3 | 109 ng/ dL | Standard Deviation 93 |
| Testosterone Gel + Oral Dutasteride | Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. | Dihydrotestosterone (DHT), baseline | 28 ng/ dL | Standard Deviation 15 |
Secondary
Signs and Symptoms Benign Prostatic Hyperplasia (BPH): Post-voiding Residual (PVR) Urinary Volume
Time frame: Baseline, 3-months, 6-months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Testosterone Gel + Oral Placebo | Signs and Symptoms Benign Prostatic Hyperplasia (BPH): Post-voiding Residual (PVR) Urinary Volume | Baseline Post Residual Volume (PVR) | 43 cc | Standard Deviation 44 |
| Testosterone Gel + Oral Placebo | Signs and Symptoms Benign Prostatic Hyperplasia (BPH): Post-voiding Residual (PVR) Urinary Volume | 3 month Post Residual Volume | 36 cc | Standard Deviation 36 |
| Testosterone Gel + Oral Placebo | Signs and Symptoms Benign Prostatic Hyperplasia (BPH): Post-voiding Residual (PVR) Urinary Volume | 6 month Post Residual Volume | 39 cc | Standard Deviation 45 |
| Testosterone Gel + Oral Dutasteride | Signs and Symptoms Benign Prostatic Hyperplasia (BPH): Post-voiding Residual (PVR) Urinary Volume | Baseline Post Residual Volume (PVR) | 48 cc | Standard Deviation 55 |
| Testosterone Gel + Oral Dutasteride | Signs and Symptoms Benign Prostatic Hyperplasia (BPH): Post-voiding Residual (PVR) Urinary Volume | 3 month Post Residual Volume | 41 cc | Standard Deviation 42 |
| Testosterone Gel + Oral Dutasteride | Signs and Symptoms Benign Prostatic Hyperplasia (BPH): Post-voiding Residual (PVR) Urinary Volume | 6 month Post Residual Volume | 32 cc | Standard Deviation 36 |
Secondary
Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men (Uroflow)
Time frame: Baseline, 3-months, 6-months
Population: per protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Testosterone Gel + Oral Placebo | Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men (Uroflow) | Baseline Uroflow, Baseline | 13.8 cc/sec | Standard Deviation 3 |
| Testosterone Gel + Oral Placebo | Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men (Uroflow) | Uroflow after 3 months of treatment | 12.7 cc/sec | Standard Deviation 3.4 |
| Testosterone Gel + Oral Placebo | Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men (Uroflow) | Uroflow after 6 months of treatment | 13.8 cc/sec | Standard Deviation 5.1 |
| Testosterone Gel + Oral Dutasteride | Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men (Uroflow) | Baseline Uroflow, Baseline | 13.4 cc/sec | Standard Deviation 3.5 |
| Testosterone Gel + Oral Dutasteride | Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men (Uroflow) | Uroflow after 3 months of treatment | 13.2 cc/sec | Standard Deviation 5.8 |
| Testosterone Gel + Oral Dutasteride | Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men (Uroflow) | Uroflow after 6 months of treatment | 14.6 cc/sec | Standard Deviation 6.7 |
Secondary
The Effects of T Alone or in Combination With Dutasteride on Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men With Benign Prostatic Hyperplasia. (International Prostate Symptom Score)
International Prostate Symptom Score to assess lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Minimum score = 0, maximum score = 35; mildly symptomatic score = 0-7; moderately symptomatic score = 8-19; severely symptomatic score = 20-35; no subscales.
Time frame: Baseline, Month 3, Month 6
Population: per protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Testosterone Gel + Oral Placebo | The Effects of T Alone or in Combination With Dutasteride on Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men With Benign Prostatic Hyperplasia. (International Prostate Symptom Score) | Baseline IPSS | 13.5 score | Standard Deviation 2.7 |
| Testosterone Gel + Oral Placebo | The Effects of T Alone or in Combination With Dutasteride on Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men With Benign Prostatic Hyperplasia. (International Prostate Symptom Score) | Month 3- IPSS | 11.6 score | Standard Deviation 5 |
| Testosterone Gel + Oral Placebo | The Effects of T Alone or in Combination With Dutasteride on Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men With Benign Prostatic Hyperplasia. (International Prostate Symptom Score) | Month 6 IPSS | 11.1 score | Standard Deviation 5.2 |
| Testosterone Gel + Oral Dutasteride | The Effects of T Alone or in Combination With Dutasteride on Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men With Benign Prostatic Hyperplasia. (International Prostate Symptom Score) | Baseline IPSS | 13.3 score | Standard Deviation 3.1 |
| Testosterone Gel + Oral Dutasteride | The Effects of T Alone or in Combination With Dutasteride on Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men With Benign Prostatic Hyperplasia. (International Prostate Symptom Score) | Month 3- IPSS | 10.2 score | Standard Deviation 5.4 |
| Testosterone Gel + Oral Dutasteride | The Effects of T Alone or in Combination With Dutasteride on Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men With Benign Prostatic Hyperplasia. (International Prostate Symptom Score) | Month 6 IPSS | 10.3 score | Standard Deviation 6.6 |