Clinical trial NCT01419236: A Study of Ejaculatory Dysfunction in Men With Low Testosterone Levels
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ejaculatory Dysfunction
Hypogonadism
Keywords: Ejaculatory Dysfunction
Orgasmic Dysfunction
Sexual Dysfunction
Climax Dysfunction
Erectile Dysfunction
Impotence
Hypogonadism
Low testosterone
Low t
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2011-08-18
Enrollment: 76
Sex: MALE
Minimum age (years): 26
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

Primary outcomes:
measure: Change From Baseline in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF) Ejaculatory Function Score at 16 Weeks
timeFrame: Baseline, 16 weeks
Secondary outcomes:
measure: Change From Baseline in Ejaculate Volume at 16 Weeks
timeFrame: Baseline, 16 weeks
measure: Change From Baseline in Sexual Activity Log: Perceived Volume of Ejaculate at 16 Weeks
timeFrame: Baseline, 16 weeks
measure: Change From Baseline in Sexual Activity Log: Perceived Force of Ejaculation at 16 Weeks
timeFrame: Baseline, 16 weeks
measure: Change From Baseline in Sexual Activity Log: Delayed Ejaculation at 16 Weeks
timeFrame: Baseline, 16 weeks
measure: Change From Baseline in Sexual Activity Log: Frequency of Sexual Attempts at 16 Weeks
timeFrame: Baseline, up to 16 weeks
measure: Change From Baseline in Sexual Activity Log: Orgasmic Pleasure at 16 Weeks
timeFrame: Baseline, 16 weeks
measure: Change From Baseline in the International Index of Erectile Function (IIEF)-Orgasmic Function Domain Score at 16 Weeks
timeFrame: Baseline, 16 weeks
measure: Change From Baseline in MSHQ-EjD-SF Bother/Satisfaction Score at 16 Weeks
timeFrame: Baseline, 16 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: 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.
state: California
city: San Diego
country: United States
facility: 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.
state: California
city: New Orleans
country: United States
facility: 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.
state: Louisiana
city: Brookline
country: United States
facility: 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.
state: Massachusetts
city: Great Neck
country: United States
facility: 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.
state: New York
city: New York
country: United States
facility: 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.
state: New York
city: Quebec City
country: Canada
facility: 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.
state: Quebec
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: Paduch DA, Polzer PK, Ni X, Basaria S. Testosterone Replacement in Androgen-Deficient Men With Ejaculatory Dysfunction: A Randomized Controlled Trial. J Clin Endocrinol Metab. 2015 Aug;100(8):2956-62. doi: 10.1210/jc.2014-4434. Epub 2015 Jul 9.