Effect of Dihydrotestosterone (DHT) on Prostate Tissue [Short Title: DHT-3] (NCT00490022) | Clinical Trial Compass
CompletedPhase 1/2
Effect of Dihydrotestosterone (DHT) on Prostate Tissue [Short Title: DHT-3]
United States31 participantsStarted 2007-06
Plain-language summary
The purpose of this research study is to understand the effects of a male hormone normally made in the body called Dihydrotestosterone (DHT) on the prostate gland that is located under the bladder. The knowledge gained from this study may be used to help in the future to develop a safe male hormonal contraceptive to prevent pregnancy, in the safe treatment of low male hormone levels in men, and in the treatment and prevention of diseases of the prostate.
The investigators will be giving DHT in a gel form, to be applied to the skin, or a placebo gel (with no active drug in it). The investigators want to see the effects of DHT on levels of hormones in the blood and in the prostate gland itself. In addition, the investigators will be studying the effects of DHT on the cells and genes expressed within the prostate.
The effect of DHT on the prostate is not known. Some studies suggest blocking production of DHT in the prostate helps growth of the gland with aging (a condition known as benign prostatic hyperplasia, or BPH for short) and may prevent prostate cancer. On the other hand, DHT administration may shrink the prostate, suggesting it may be beneficial for some men. Therefore, further studies looking at the effect of DHT on the prostate are needed.
Who can participate
Age range
35 Years – 55 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Males 35-55 years old
* Normal serum total testosterone (300 ng/dl-1000 ng/dl)
* Normal Luteinizing Hormone \[LH\] and Follicle Stimulating Hormone \[FSH\] levels
* Informed consent
* Taking no regular medications
* Normal baseline prostate ultrasound, hematology, and liver function tests
Exclusion Criteria:
* History of prostate cancer
* Prostate Specific Antigen \[PSA\] \> 2.0
* American Urological Association \[AUA\] prostate symptom score \> 10
* History of testosterone or anabolic steroid use in the past
* Chronic medical illness or prostate disease
* History of a bleeding disorder or need for anticoagulation
* A first-degree relative (i.e. father, brother) with a history of prostate cancer
* Abnormal digital rectal examination
* Skin condition that might interfere with or be exacerbated by DHT gel use
* History of untreated sleep apnea and/or psychiatric problems
* Participation in another study in the past 2 months
* Participating in a regular physical relationship with a pregnant woman
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prostate Tissue DHT and Testosterone Levels After 28 Days of Treatment With Dihydrotestosterone [DHT] Gel Versus Placebo Gel.