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 States76 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 range26 Years
SexMALE
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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…
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