A Study of Ejaculatory Dysfunction in Men With Low Testosterone Levels

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01419236
First received: August 16, 2011
Last updated: January 8, 2014
Last verified: January 2014

August 16, 2011
January 8, 2014
August 2011
December 2013   (final data collection date for primary outcome measure)
Change from Baseline in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF) Ejaculatory Function Score at 16 Weeks [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01419236 on ClinicalTrials.gov Archive Site
  • Change from Baseline in Ejaculate Volume at 16 Weeks [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Sexual Activity Log at 16 Weeks [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in the International Index of Erectile Function-Orgasmic Function Domain Score at 16 Weeks [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in MSHQ-EjD-SF Bother/Satisfaction Score at 16 Weeks [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Ejaculatory Dysfunction in Men With Low Testosterone Levels
A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Explore the Impact of Testosterone Solution 2% on Symptoms of Ejaculatory Dysfunction in Men With Testosterone Deficiency

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Ejaculatory Dysfunction
  • Hypogonadism
  • Drug: Testosterone Solution 2%
    Administered topically
    Other Names:
    • Axiron
    • LY900011
  • Drug: Placebo Solution
    Administered topically
  • Experimental: Testosterone Solution 2% 60 mg
    Testosterone Solution 2% 60 mg applied topically once daily with possible 1-time titration to 30 mg/day or 90 mg/day for 16 weeks
    Intervention: Drug: Testosterone Solution 2%
  • Placebo Comparator: Placebo
    Placebo solution applied topically once daily for 16 weeks
    Intervention: Drug: Placebo Solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
146
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Total testosterone level <10.4 nmol/L (300 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 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 kg/m2 at screening
  • Significant peripheral neuropathy affecting erectile, ejaculatory, or orgasmic function
  • Hematocrit ≥50% at screening
  • Exhibit systolic blood pressure >170 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 (eg, 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)
Male
26 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01419236
13981, I5E-MC-TSAB
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP