- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01893281
The Effect of Testosterone Topical Solution (LY900011) in Hypogonadal Men With Suboptimal Response to a Topical Testosterone Gel
October 21, 2014 updated by: Eli Lilly and Company
This study will evaluate if testosterone solution can raise testosterone hormone levels into the normal range after treatment for up to 9 Weeks, in those participants with a documented history of subtherapeutic levels [total testosterone <300 nanograms per deciliter (ng/dL)] when previously treated with a topical testosterone gel.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
78
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Encinitas, California, United States, 92024
- 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.
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San Diego, California, United States, 92103
- 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.
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Colorado
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Parker, Colorado, United States, 80134
- 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.
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Georgia
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Gainesville, Georgia, United States, 30501
- 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.
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Idaho
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Coeur D' Alene, Idaho, United States, 83814
- 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.
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Indiana
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Anderson, Indiana, United States, 46011
- 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.
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Jeffersonville, Indiana, United States, 47130
- 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.
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Montana
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Billings, Montana, United States, 59101
- 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.
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Nebraska
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Elkhorn, Nebraska, United States, 68022
- 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.
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New Jersey
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Marlton, New Jersey, United States, 08053
- 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.
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New York
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Garden City, New York, United States, 11530
- 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.
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Poughkeepsie, New York, United States, 12601
- 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.
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North Carolina
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Cary, North Carolina, United States, 27518
- 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.
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Concord, North Carolina, United States, 28025
- 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.
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Salisbury, North Carolina, United States, 28144
- 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.
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Tennessee
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Knoxville, Tennessee, United States, 37920
- 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.
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Texas
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Austin, Texas, United States, 78731
- 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.
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Marshall, Texas, United States, 75670
- 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.
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Round Rock, Texas, United States, 78681
- 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.
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San Antonio, Texas, United States, 78228
- 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.
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Washington
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Seattle, Washington, United States, 98104
- 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.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Able to read, understand, and provide signed informed consent before starting trial activities related to this study (including discontinuing testosterone replacement therapy prior to Screening)
- Male participants with a diagnosis of hypogonadism and documented biochemical failure (total testosterone <300 ng/dL) when treated with the highest dose of a topical testosterone gel tolerated by the participant. Documentation of biochemical failure includes: the name and dose of the topical testosterone gel, a lab report showing a total testosterone level <300 ng/dL while on therapy, or a written chart report stating that there was a clear lack of efficacy, including the participant's serum total testosterone level at the time of failure
- Screening serum total testosterone level of <300 ng/dL (based on the average of 2 morning blood samples taken at least 30 minutes apart) at Screening
- Prostate Specific Antigen (PSA) <4 nanogram per milliliter (ng/mL) at Screening
- If the participant is receiving testosterone replacement therapy and is willing to discontinue testosterone replacement therapy to enter the study, their screening total testosterone level cannot be checked until at least 14 days after discontinuing topical therapies, or after at least 28 days for participants using short-acting intramuscular (IM) therapies
Exclusion Criteria:
- Any previous treatment with testosterone topical solution (LY900011)
- 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
- Severe sleep apnea (untreated or unsuccessfully treated) in the opinion of the study investigator
- Use of long-acting IM testosterone undecanoate in the 6-month period prior to Screening
- History of the use of an implanted testosterone pellets (Testopel)
- International Prostate Symptom Score (IPSS) total score >19 at Screening
- Hematocrit ≥50% at Screening. For sites located at elevations ≥4500 feet, participants will be excluded with hematocrit >54% according to investigator discretion. Any participant with a hematocrit >54% at later study visits will be withdrawn from the study
- Significant history of allergy and/or sensitivity to the drug products or excipients, including any history of sensitivity to testosterone and/or sunscreens
- Dermatologic condition in underarm area that might interfere with testosterone absorption (for example, eczema) or that could be exacerbated by topical testosterone replacement therapy
- History of luteinizing hormone-releasing hormone (LHRH) antagonist or agonist treatment in the 6 months prior to Screening
- Exhibit any evidence of congestive heart failure [New York Heart Association (NYHA) Class 2 or above] within 6 months prior to Screening
- Exhibit evidence of severe renal impairment [creatinine clearance <30 milliliter per minute (mL/min) as determined by the Cockcroft-Gault formula] at Screening
- Exhibit a history of severe liver disease or clinical evidence of hepatic impairment at Screening
- Any condition that would interfere with the participant's ability to provide informed consent, or comply with study instructions, or would place the participant at increased risk, or might confound the interpretation of the study results
- Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
- Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device (other than the investigational product used in this study), or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Topical Testosterone Solution
Topical Testosterone Solution 30 milligrams up to 120 milligrams per day (mg/day) administered topically to axillae titrated based on testosterone levels.
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Administered topically to axillae.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants Achieving Normal Serum Testosterone Levels
Time Frame: Baseline through Study Completion (Up to 9 Weeks)
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Normal serum testosterone level is defined as ≥300 to ≤1050 nanograms/deciliter (ng/dL).
Serum testosterone levels were measured by liquid chromatography and tandem mass spectrometry (LC/MS-MS).
Percentage of participants = (number of participants who achieved normal serum testosterone level) / (number of treated participants who had serum testosterone level measured) * 100.
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Baseline through Study Completion (Up to 9 Weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Serum Testosterone Levels
Time Frame: Baseline, Study Completion (Up to 9 Weeks)
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Serum testosterone levels were measured by LC/MS-MS.
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Baseline, Study Completion (Up to 9 Weeks)
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Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Time Frame: Study Days 15, 22, 36, 43, 57, 64 and endpoint
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PGI-I for sexual drive is a participant-rated questionnaire that measure change in sexual drive after a participant begins the study drug.
The questionnaire was completed at every visit post baseline using a 7-point scale where a score of 1 indicated that the participant's sexual drive was "very much better," a score of 4 indicated that the participant had experienced "no change" in sexual drive and a score of 7 indicated that the participant's sexual drive was "very much worse".
Percentage of participants = (number of participants in the category) / (total number of participants who responded to the questionnaire) * 100.
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Study Days 15, 22, 36, 43, 57, 64 and endpoint
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Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Time Frame: Study Days 15, 22, 36, 43, 57, 64 and endpoint
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PGI-I for energy level is a participant-rated questionnaire that measures change in energy level after a participant begins the study drug.
The questionnaire was completed at every visit post baseline using a 7-point scale where a score of 1 indicated that the participant's energy level was "very much better," a score of 4 indicated that the participant had experienced "no change" in energy level and a score of 7 indicated that the participant's energy level was "very much worse".
Percentage of participants = (number of participants in the category) / (total number of participants who responded to the questionnaires) * 100.
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Study Days 15, 22, 36, 43, 57, 64 and endpoint
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
July 2, 2013
First Submitted That Met QC Criteria
July 2, 2013
First Posted (Estimate)
July 9, 2013
Study Record Updates
Last Update Posted (Estimate)
October 27, 2014
Last Update Submitted That Met QC Criteria
October 21, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Gonadal Disorders
- Hypogonadism
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Androgens
- Anabolic Agents
- Pharmaceutical Solutions
- Testosterone
- Methyltestosterone
- Testosterone undecanoate
- Testosterone enanthate
- Testosterone 17 beta-cypionate
Other Study ID Numbers
- 14980
- I5E-US-TSBC (Other Identifier: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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