CompletedPhase 2

Oral T7 Oral Testosterone in Man

United States11 participantsStarted 2009-07

Plain-language summary

The purpose of this study is to test how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future.

Who can participate

Age range

18 Years – 50 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 between 18 and 50 years of age * In good health based on normal screening evaluation (consisting of a medical history, physical exam normal serum chemistry, hematology, and baseline hormone levels. * Must agree to not participate in another research drug study * Must agree to not donate blood * Must be willing to comply with the study protocol and procedures Exclusion Criteria: * Men in poor general health, with abnormal blood results (clinical laboratory tests or hormone values) * A known history of alcohol or drug abuse * Participation in a long-term male contraceptive study within the past month * History of bleeding disorders or current use of anti-coagulants * History of sleep apnea * History of major psychiatric disorder * Body mass index \> 37 * Infertility * Hematocrit \> 55 or \< 30 * PSA \>4

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

Maximum Testosterone Concentration

Timeframe: 0,1,2,4,8,and 12-hour post dose

Serum Dihydrotestosterone Concentration

Timeframe: 0,1,2,4,8,and 12-hour post dose

Serum Estradiol Concentration

Timeframe: 0,1,2,4,8,and 12-hour post dose

Trial details

NCT IDNCT00842751

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-11

Results submitted2011-03-21

View on ClinicalTrials.gov More Healthy Males trials

Who can participate

Age range

18 Years – 50 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.