WithdrawnPhase 2

ITT-5 Mechanisms of Spermatogenesis in Man

Stopped: No funding was obtained for this study.

United States0Started 2019-06

Plain-language summary

The purpose of this investigational drug study is to determine how much male hormone, testosterone, is needed to maintain sperm production in the testis.

Who can participate

Age range

18 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 age 18-55 * In general good health based on normal screening evaluation * Normal serum testosterone, lutenizing hormone (LH) and follicle stimulating hormone (FSH) * Prostate Specific Antigen (PSA) \< 3.0 * Agrees not to donate blood or participate in another research study during the study * Informed consent * Must be willing to use a reliable form of contraception during the study Exclusion Criteria: * Participation in a long-term male contraceptive study within the past three months * History of testosterone or anabolic steroid abuse in the past * History of or current skin disorder that will interfere with testosterone gel * Poor general health or significantly abnormal screening blood results * History of or current testicular or prostate disease * History of a bleeding disorder or need for anticoagulation * History of untreated sleep apnea and/or major psychiatric problems * BMI \> 32 * History of or current liver disease * Chronic pain syndrome * Current use of terfenidine, astemizole, cisapride, budesonide, felodipine, fluticasone, lovastatin, midazolam, sildenafil, or vardenafil * Use of glucocorticoids or underlying adrenal insufficiency * Active drug or alcohol abuse within the past year

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

Sperm concentration

Timeframe: 16 weeks

Trial details

NCT IDNCT02147964

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12

View on ClinicalTrials.gov More Gonadotropin Deficiency trials