Trial Outcomes & Findings for Effect of Dihydrotestosterone (DHT) on Prostate Tissue [Short Title: DHT-3] (NCT NCT00490022)

Results Overview

After 4 weeks of either daily dihydrotestosterone transdermal gel or placebo gel, subjects underwent a prostate biopsy. Intraprostatic hormone concentrations, specifically DHT and Testosterone, were measured. Unit of measure is ng/g.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

31 participants

Primary outcome timeframe

28-days

Results posted on

2011-06-27

Participant Flow

Up to 55 normal, healthy men between the ages of 35-55 will be recruited for this study. All subject activities will occur at the University of Washington in Seattle Washington.

Subjects must meet all study protocol inclusion criteria such as informed consent, normal lab values, normal physical examination and normal prostate ultrasound, and not have exclusion criteria such as a first degree relative with or personal history of prostate cancer, PSA \>2.0 or a history of a bleeding disorder or need for anticoagulation.

Participant milestones

Participant milestones
Measure	Placebo DHT Gel Placebo gel for one month	DHT Gel DHT gel (70 mg/day) for one month
Overall Study STARTED	16	15
Overall Study COMPLETED	15	12
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo DHT Gel Placebo gel for one month	DHT Gel DHT gel (70 mg/day) for one month
Overall Study Adverse Event	0	2
Overall Study Withdrawal by Subject	1	0
Overall Study Subject failed to disclose concommitant	0	1

Baseline Characteristics

Effect of Dihydrotestosterone (DHT) on Prostate Tissue [Short Title: DHT-3]

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo DHT Gel n=16 Participants Placebo gel for one month	DHT Gel n=15 Participants DHT gel (70 mg/day) for one month	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=99 Participants	15 Participants n=107 Participants	31 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age Continuous	44.4 years STANDARD_DEVIATION 6.7 • n=99 Participants	42.7 years STANDARD_DEVIATION 1.6 • n=107 Participants	43.6 years STANDARD_DEVIATION 4.2 • n=206 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Male	16 Participants n=99 Participants	15 Participants n=107 Participants	31 Participants n=206 Participants
Region of Enrollment United States	16 participants n=99 Participants	15 participants n=107 Participants	31 participants n=206 Participants

PRIMARY outcome

Timeframe: 28-days

After 4 weeks of either daily dihydrotestosterone transdermal gel or placebo gel, subjects underwent a prostate biopsy. Intraprostatic hormone concentrations, specifically DHT and Testosterone, were measured. Unit of measure is ng/g.

Outcome measures

Outcome measures
Measure	Placebo DHT Gel n=15 Participants Placebo gel for one month	DHT Gel n=12 Participants DHT gel (70 mg/day) for one month
Prostate Tissue DHT and Testosterone Levels After 28 Days of Treatment With Dihydrotestosterone [DHT] Gel Versus Placebo Gel. DHT concentrations	2.8 ng/g Standard Deviation 0.2	3.1 ng/g Standard Deviation 0.5
Prostate Tissue DHT and Testosterone Levels After 28 Days of Treatment With Dihydrotestosterone [DHT] Gel Versus Placebo Gel. Testosterone Concentrations	0.6 ng/g Standard Deviation 0.2	0.4 ng/g Standard Deviation 0.1

SECONDARY outcome

Timeframe: 28-days

Prostate epithelial cell proliferation in the prostate biopsy tissue was measured using Ki-67 immunohistochemical staining of prostate epithelium as a marker of cell proliferation (values are number of Ki-67 positive stained cells per 100 prostate epithelial cells). The placebo and treatment groups were compared.

Outcome measures

Outcome measures
Measure	Placebo DHT Gel n=15 Participants Placebo gel for one month	DHT Gel n=12 Participants DHT gel (70 mg/day) for one month
Prostate Epithelial Cell Proliferation	1.3 #pos.Ki-67cells per100 prst. epth cells Standard Deviation 0.5	0.7 #pos.Ki-67cells per100 prst. epth cells Standard Deviation 0.9

Adverse Events

Placebo DHT Gel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

DHT Gel

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo DHT Gel n=16 participants at risk Placebo gel for one month	DHT Gel n=15 participants at risk DHT gel (70 mg/day) for one month
Gastrointestinal disorders Rectal Bleed	0.00% 0/16	6.7% 1/15 • Number of events 1

Other adverse events

Other adverse events
Measure	Placebo DHT Gel n=16 participants at risk Placebo gel for one month	DHT Gel n=15 participants at risk DHT gel (70 mg/day) for one month
Renal and urinary disorders Urinary Frequency	0.00% 0/15	6.7% 1/15 • Number of events 1

Additional Information

Dr. Stephanie Page, PhD, MD

University of Washington

Phone: 206.616.0483

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place