A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testoster… (NCT01816295) | Clinical Trial Compass
CompletedPhase 3
A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and Energy
United States, Argentina, Canada715 participantsStarted 2013-05
Plain-language summary
The main purpose of this study is to evaluate if testosterone solution can raise testosterone hormone levels into the normal range, and also improve levels of sexual arousal, interest and drive and/or energy level, in men with low testosterone and decreased sexual arousal, interest and drive and/or decreased energy. The study will last about 16 weeks, followed by an optional 24 week open label treatment phase to investigate the long term safety of testosterone solution.
Who can participate
Age range
18 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:
* Total testosterone level \<300 nanogram per deciliter (ng/dL) \[10.4 nanomole per Liter (nmol/L)\] at each of 2 screening visits
* At least 1 symptom of testosterone deficiency, which must include decreased energy or decreased sexual drive
* Prostate Specific Antigen (PSA) \<4 nanogram per milliliter (ng/ml) at screening
Exclusion Criteria:
* Sexual partner who is or becomes pregnant at any time during the study
* Use of long-acting intramuscular (IM) testosterone undecanoate or testosterone pellets in the 6-month period prior to screening
* Body Mass Index (BMI) \>37 kilogram per square meter (kg/m\^2) at screening
* Severe lower urinary tract symptoms and/or significant prostate enlargement
* Prolactin lab test result of \>30 ng/mL at screening
* Hemoglobin A1c (HbA1c) \>11% at screening
* Hematocrit ≥50% (\>54% at elevated altitude) at screening
* Current use of any medications, herbal, and/or nutritional supplements that can interfere with testosterone
* Dermatologic condition in underarm area that might interfere with testosterone absorption (for example, eczema) or be exacerbated by topical testosterone replacement therapy
* Currently receiving treatment with cancer chemotherapy or antiandrogens
* Chronic use of systemic glucocorticoids (use for \>14 days within the 3 months prior to screening); use of non-testosterone anabolic steroids within 12 months prior to screening
* Competitive athletes involved in a sport in which they may be screened f…
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
Number of Participants With Total Serum Testosterone Concentration Within Normal Range at Week 12