Phase 2
N=76
A Study of Ejaculatory Dysfunction in Men With Low Testosterone Levels
Ejaculatory Dysfunction · Hypogonadism
Bottom Line
View on ClinicalTrials.gov: NCT01419236 ↗Enrolled (actual)
76
Serious AEs
2.6%
Results posted
Dec 2014
Primary outcome: Primary: Change From Baseline in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF) Ejaculatory Function Score at 16 Weeks — 3.61; 2.95 units on a scale — p=0.380
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Testosterone Solution 2% (Drug); Placebo Solution (Drug)
- Age
- Adult, Older Adult · 26+ yrs
- Sex
- Male
- Sponsor
- Eli Lilly and Company
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF) Ejaculatory Function Score at 16 Weeks |
3.61; 2.95 | 0.380 |
| SECONDARY Change From Baseline in Ejaculate Volume at 16 Weeks |
-0.12; 0.32 | 0.164 |
| SECONDARY Change From Baseline in Sexual Activity Log: Perceived Volume of Ejaculate at 16 Weeks |
1.85; 1.43 | 0.342 |
| SECONDARY Change From Baseline in Sexual Activity Log: Perceived Force of Ejaculation at 16 Weeks |
2.28; 1.47 | 0.079 |
| SECONDARY Change From Baseline in Sexual Activity Log: Delayed Ejaculation at 16 Weeks |
1.68; 1.38 | 0.535 |
| SECONDARY Change From Baseline in Sexual Activity Log: Frequency of Sexual Attempts at 16 Weeks |
0.89; -0.14 | 0.172 |
| SECONDARY Change From Baseline in Sexual Activity Log: Orgasmic Pleasure at 16 Weeks |
1.37; 1.05 | 0.473 |
| SECONDARY Change From Baseline in the International Index of Erectile Function (IIEF)-Orgasmic Function Domain Score at 16 Weeks |
1.21; 1.29 | 0.885 |
| SECONDARY Change From Baseline in MSHQ-EjD-SF Bother/Satisfaction Score at 16 Weeks |
-1.65; -1.62 | 0.938 |
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 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 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)
Data sourced from ClinicalTrials.gov (NCT01419236). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.