NCT01419236

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2011

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1 year until next milestone

Results Posted

Study results publicly available

December 19, 2014

Completed
Last Updated

December 19, 2014

Status Verified

December 1, 2014

Enrollment Period

2.3 years

First QC Date

August 16, 2011

Results QC Date

December 12, 2014

Last Update Submit

December 12, 2014

Conditions

Ejaculatory DysfunctionHypogonadism

Keywords

Ejaculatory DysfunctionOrgasmic DysfunctionSexual DysfunctionClimax DysfunctionErectile DysfunctionImpotenceHypogonadismLow testosteroneLow t

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (8)

  • Change From Baseline in Ejaculate Volume at 16 Weeks

    Baseline, 16 weeks

  • Change From Baseline in Sexual Activity Log: Perceived Volume of Ejaculate at 16 Weeks

    Baseline, 16 weeks

  • Change From Baseline in Sexual Activity Log: Perceived Force of Ejaculation at 16 Weeks

    Baseline, 16 weeks

  • Change From Baseline in Sexual Activity Log: Delayed Ejaculation at 16 Weeks

    Baseline, 16 weeks

  • Change From Baseline in Sexual Activity Log: Frequency of Sexual Attempts at 16 Weeks

    Baseline, up to 16 weeks

  • +3 more secondary outcomes

Study Arms (2)

Testosterone Solution 2% 60 milligrams (mg)

EXPERIMENTAL

Testosterone Solution 2% 60 mg applied topically once daily with possible 1-time titration to 30 milligrams per day (mg/day) or 90 mg/day for 16 weeks

Drug: Testosterone Solution 2%

Placebo

PLACEBO COMPARATOR

Placebo solution applied topically once daily for 16 weeks

Drug: Placebo Solution

Interventions

Testosterone Solution 2%DRUG

Administered topically

Also known as: Axiron, LY900011
Testosterone Solution 2% 60 milligrams (mg)
Placebo SolutionDRUG

Administered topically

Placebo

Eligibility Criteria

Age26 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

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, 90048, United States

Location

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, 92120, United States

Location

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, 70112, United States

Location

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, 02445, United States

Location

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, 11021, United States

Location

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, 10021, United States

Location

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.

Québec, Quebec, G1N 4V3, Canada

Location

Related Publications (2)

  • Lee H, Hwang EC, Oh CK, Lee S, Yu HS, Lim JS, Kim HW, Walsh T, Kim MH, Jung JH, Dahm P. Testosterone replacement in men with sexual dysfunction. Cochrane Database Syst Rev. 2024 Jan 15;1(1):CD013071. doi: 10.1002/14651858.CD013071.pub2.

    PMID: 38224135DERIVED

  • 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.

    PMID: 26158605DERIVED

MeSH Terms

Conditions

Ejaculatory DysfunctionHypogonadismSexual Dysfunctions, PsychologicalSexual Dysfunction, PhysiologicalErectile Dysfunction

Interventions

Testosterone Propionate

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesGonadal DisordersEndocrine System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

TestosteroneAndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2011

First Posted

August 18, 2011

Study Start

August 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 19, 2014

Results First Posted

December 19, 2014

Record last verified: 2014-12

Locations

US(6)CA(1)