A Study of Ejaculatory Dysfunction in Men With Low Testosterone Levels

Hypogonadism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01419236
• Other study ID #: 13981
• Secondary ID: I5E-MC-TSAB
• Status: Completed
• Phase: Phase 2
• First received: August 16, 2011
• Last updated: December 12, 2014
• Start date: August 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaMexico: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 26 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ejaculatory Dysfunction
• Hypogonadism

Intervention

Drug:
• Testosterone Solution 2%
Administered topically
• Placebo Solution
Administered topically

Locations

Country	Name	City	State
Canada	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Quebec City	Quebec
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Brookline	Massachusetts
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Great Neck	New York
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Los Angeles	California
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	New Orleans	Louisiana
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	New York	New York
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF) Ejaculatory Function Score at 16 Weeks	MSHQ-EjD-SF: 4 item, self-reported questionnaire assessing ejaculatory dysfunction. MSHQ-EjD-SF Ejaculatory Function Score: sum of scores for questions (Q)1 through Q3 about frequency and strength of ejaculations and volume of ejaculate for sexual activity attempts during past month. Ejaculation frequency was rated 1 (could not ejaculate) to 5 (all the time); strength and volume from 0 (could not ejaculate) to 5 (as strong/much as it always has been). Total Ejaculatory Function Score ranged from 1 to 15. Least-squares (LS) mean of change from baseline calculated using repeated measures mixed-effects model (MMRM) including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level [=200 nanograms per deciliter (ng/dL) versus (vs.) <200 ng/dL], baseline erectile dysfunction (ED) severity (normal, mild, moderate, severe), and centered baseline ejaculatory function score as fixed effects, and unstructured covariance structure for modeling correlation.	Baseline, 16 weeks	No
Secondary	Change From Baseline in Ejaculate Volume at 16 Weeks	The change from baseline in ejaculate volume was determined by actual measurement of semen volume in milliliters (mL). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (=200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline ejaculatory volume as fixed effects, and unstructured covariance structure for modeling correlation.	Baseline, 16 weeks	No
Secondary	Change From Baseline in Sexual Activity Log: Perceived Volume of Ejaculate at 16 Weeks	The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Ejaculatory functioning included perceived volume of ejaculate, perceived force of ejaculation, delayed ejaculation, and frequency. Reported is the perceived volume of ejaculate rated from 0 (no ejaculate) to 10 (high volume of ejaculate). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (=200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline ejaculatory volume as fixed effects, and unstructured covariance structure for modeling correlation.	Baseline, 16 weeks	No
Secondary	Change From Baseline in Sexual Activity Log: Perceived Force of Ejaculation at 16 Weeks	The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Ejaculatory functioning included perceived volume of ejaculate, perceived force of ejaculation, delayed ejaculation, and frequency. Reported is the perceived force of ejaculation rated from 0 (could not ejaculate) to 10 (strong ejaculation). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (=200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline perceived force of ejaculation as fixed effects, and unstructured covariance structure for modeling correlation.	Baseline, 16 weeks	No
Secondary	Change From Baseline in Sexual Activity Log: Delayed Ejaculation at 16 Weeks	The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Ejaculatory functioning included perceived volume of ejaculate, perceived force of ejaculation, delayed ejaculation, and frequency. Reported is delayed ejaculation rated from 0 (did not ejaculate) to 10 (optimal/best ejaculate time). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (=200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline delayed ejaculation as fixed effects, and unstructured covariance structure for modeling correlation.	Baseline, 16 weeks	No
Secondary	Change From Baseline in Sexual Activity Log: Frequency of Sexual Attempts at 16 Weeks	The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Ejaculatory functioning included perceived volume of ejaculate, perceived force of ejaculation, delayed ejaculation, and frequency. Reported is the change from baseline number of sexual attempts at 16 weeks. LS mean of change from baseline was calculated using an analysis of covariance (ANCOVA) including treatment group, region, baseline total testosterone level, baseline ED severity (normal, mild, moderate, severe) as fixed effects, and centered baseline as a covariate.	Baseline, up to 16 weeks	No
Secondary	Change From Baseline in Sexual Activity Log: Orgasmic Pleasure at 16 Weeks	The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Reported is orgasmic pleasure rated from 0 (no pleasure) to 10 (excellent). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (=200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline orgasmic pleasure as fixed effects, and unstructured covariance structure for modeling correlation.	Baseline, 16 weeks	No
Secondary	Change From Baseline in the International Index of Erectile Function (IIEF)-Orgasmic Function Domain Score at 16 Weeks	IIEF: 15 item, self-reported questionnaire assessing overall erectile function and satisfaction during past month. Orgasmic Function Domain Score: sum of IIEF scores for Q9 and Q10. In Q9, participants (pts) identified how often they ejaculated when having sexual stimulation or intercourse. In Q10, pts identified how often they had a feeling of an orgasm with or without ejaculation when having sexual stimulation or intercourse. For each Q, scores ranged from 0 (no sexual stimulation or intercourse), 1 (almost never or never) to 5 (almost always or always). Total Orgasmic Function Domain Scores ranged from 0 to 10. LS mean of change from baseline calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (=200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline Orgasmic Function Domain Score as fixed effects, and unstructured covariance structure for modeling correlation.	Baseline, 16 weeks	No
Secondary	Change From Baseline in MSHQ-EjD-SF Bother/Satisfaction Score at 16 Weeks	The MSHQ-EjD-SF was a 4 item, self-reported questionnaire used for the assessment of EjD during the past month. The MSHQ-EjD-SF Bother/Satisfaction Score was based on Q4: "If you have had any ejaculation difficulties or have been unable to ejaculate, have you been bothered by this?" Scores ranged from 0 (no problem with ejaculation), 1 (not at all bothered) to 5 (extremely bothered). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (=200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline Bother/Satisfaction Score as fixed effects, and unstructured covariance structure for modeling correlation.	Baseline, 16 weeks	No