A Study of Ejaculatory Dysfunction in Men With Low Testosterone Levels (NCT01419236) | Clinical Trial Compass
CompletedPhase 2
A Study of Ejaculatory Dysfunction in Men With Low Testosterone Levels
United States, Canada76 participantsStarted 2011-08
Plain-language summary
The purpose of this study is to see if testosterone solution 2% can impact symptoms of ejaculatory dysfunction in men with low testosterone.
Who can participate
Age range
26 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 \<10.4 nanomoles per liter (nmol/L) \[300 nanograms per deciliter (ng/dL)\] at screening
* Presents with 1 or more of the following symptom(s) of ejaculatory dysfunction: delayed ejaculation, anejaculation, decreased force of ejaculation, or decreased ejaculatory volume, as determined by investigator assessment
* Prostate-Specific Antigen (PSA) \<4 nanograms per milliliter (ng/mL) at screening
Exclusion Criteria:
* Sexual partner who is or becomes pregnant at any time during the study
* Premature ejaculation as determined by investigator assessment
* Currently receiving testosterone replacement therapy or have a history of insufficient response to testosterone replacement therapy for ejaculatory dysfunction symptoms
* Currently receiving treatment with cancer chemotherapy or antiandrogens
* History of use of estrogenizing agents
* Current use of warfarin
* History of selective serotonin reuptake inhibitor (SSRI) and/or serotonin-norepinephrine reuptake inhibitor (SNRI) treatment in the 6 months prior to screening
* History of frequent opioid use within 30 days prior to screening, with exception of treatment for chronic pain as determined by investigator.
* Body Mass Index (BMI) \>35 kilograms per square meter (kg/m\^2) at screening
* Significant peripheral neuropathy affecting erectile, ejaculatory, or orgasmic function
* Hematocrit ≥50% at screening
* Exhibit systolic blood pressure \>170 millimeters of mercury (mm Hg) or \<9…
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
Change From Baseline in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF) Ejaculatory Function Score at 16 Weeks