A Study of Ejaculatory Dysfunction in Men With Low Testosterone Levels
Condition: Ejaculatory Dysfunction; Hypogonadism
MeSH terms: Hypogonadism
Intervention: Testosterone Solution 2%; Placebo Solution
Intervention description: Administered topically; Administered topically
Intervention MeSH terms: Pharmaceutical Solutions; Testosterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 76.0
Sex: Male
Minimum age: 26 Years
Healthy volunteers: No
Keywords: Ejaculatory Dysfunction; Orgasmic Dysfunction; Sexual Dysfunction; Climax Dysfunction; Erectile Dysfunction; Impotence; Hypogonadism; Low testosterone; Low t

Summary:

      The purpose of this study is to see if testosterone solution 2% can impact symptoms of
      ejaculatory dysfunction in men with low testosterone.
    

Eligibility criteria:

        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 <90 mm Hg or
             diastolic blood pressure >100 mm Hg or <50 mm Hg at screening (if stress is suspected,
             retest under basal conditions at screening), or have history of malignant hypertension

          -  History of any of the following coronary conditions within 90 days of screening:
             myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary
             intervention (for example, angioplasty or stent placement)

          -  Known or suspected carcinoma (or history of carcinoma) of the prostate or suspicious
             nodules on digital rectal exam at screening

          -  Known or suspected breast cancer (or history of breast cancer) or other active cancer
             (with the exception of nonmelanotic skin cancer)