HypogonadismPhase 4NCT01893281

The Effect of Testosterone Topical Solution (LY900011) in Hypogonadal Men With Suboptimal Response to a Topical Testosterone Gel

A Phase 4 study testing Topical Testosterone Solution in people with Hypogonadism, run by Eli Lilly and Company at 21 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Hypogonadism
What is being tested?: Topical Testosterone Solution
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: 21 sitesUnited States
Study dates: Jul 2013to Jan 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Show all 17Show fewer

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

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

United States21 sites

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.
Anderson, Indiana, 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.
Austin, Texas, 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.
Billings, Montana, 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.
Cary, North Carolina, 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.
Coeur d'Alene, Idaho, 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.
Concord, North Carolina, 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.
Elkhorn, Nebraska, 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.
Encinitas, California, 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.
Gainesville, Georgia, 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.
Garden City, New York, 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.
Jeffersonville, Indiana, 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.
Knoxville, Tennessee, 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.
Marlton, New Jersey, 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.
Marshall, Texas, 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.
Parker, Colorado, 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.
Poughkeepsie, New York, 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.
Round Rock, Texas, 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.
Salisbury, North Carolina, 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.
San Antonio, Texas, 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.
San Diego, California, 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.
Seattle, Washington, 98104

Other trials in United States

About this study

Conditions: Hypogonadism
Being tested: Topical Testosterone Solution
Medical subject headings: Hypogonadism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Topical Testosterone SolutionDrug
Also called LY900011, Axiron, Testosterone Solution 2%
Administered topically to axillae.

Study groups in NCT01893281
Study group	Role	What they receive
Topical Testosterone Solution	Experimental	Topical Testosterone Solution 30 milligrams up to 120 milligrams per day (mg/day) administered topically to axillae titrated based on testosterone levels. Receives: Drug: Topical Testosterone Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Achieving Normal Serum Testosterone Levels
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.
Measured: Baseline through Study Completion (Up to 9 Weeks)

Secondary outcomes (3)

Change From Baseline in Serum Testosterone Levels
Serum testosterone levels were measured by LC/MS-MS.
Measured: Baseline, Study Completion (Up to 9 Weeks)
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
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.
Measured: Study Days 15, 22, 36, 43, 57, 64 and endpoint
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
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.
Measured: Study Days 15, 22, 36, 43, 57, 64 and endpoint

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Jan 2014

First posted9 Jul 2013 (estimated)
Study startJul 2013
Primary completionJan 2014
Study completionJan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypogonadismStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01893281
Sponsor's protocol ID: 14980
Other IDs: I5E-US-TSBC
Status last verified: Oct 2014
First submitted: 2 Jul 2013
Last updated: 27 Oct 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Anticipated Stigma, Illness Identity, and Quality of Life in Male Hypogonadism
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RecruitingPhase 3
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Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
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RecruitingObservational study
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All Hypogonadism trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Testosterone Topical Solution (LY900011) in Hypogonadal Men With Suboptimal Response to a Topical Testosterone Gel
ClinicalTrials.gov ID: NCT01893281
Acronym / sponsor ID: 14980
Conditions: Hypogonadism
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jul 2013
Primary completion: Jan 2014 (actual)
Study completion: Jan 2014 (actual)
First posted: 9 Jul 2013 (estimated)
Results: Posted 27 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Topical Testosterone Solution	Experimental	Drug: Topical Testosterone SolutionTopical Testosterone Solution 30 milligrams up to 120 milligrams per day (mg/day) administered topically to axillae titrated based on testosterone levels.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Topical Testosterone SolutionAlso: LY900011, Axiron, Testosterone Solution 2%Administered topically to axillae.	Drug	Topical Testosterone Solution

Primary outcome

Percentage of Participants Achieving Normal Serum Testosterone Levels
Time frame: Baseline through Study Completion (Up to 9 Weeks)
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.

3 secondary outcomes

Change From Baseline in Serum Testosterone Levels
Time frame: Baseline, Study Completion (Up to 9 Weeks)
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
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

Results and safety

Results posted to the registry on 27 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Topical Testosterone Solution	78	75

Primary outcome: Percentage of Participants Achieving Normal Serum Testosterone Levels

Time frame: Baseline through Study Completion (Up to 9 Weeks). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Topical Testosterone Solution n = 76
Value	94.7 (87 to 99)

Population analysed: All enrolled participants who received at least 1 dose of study drug and had serum testosterone level measurement.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Topical Testosterone Solution	0 of 78 (0%)	22 of 78 (28.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypogonadism

RecruitingObservational study
Anticipated Stigma, Illness Identity, and Quality of Life in Male Hypogonadism
Hypogonadism, Male, Endocrine Disease
Recruiting
Feasibility of a Digital Self-help Program for Functional Hypothalamic Amenorrhea (HEAL-FHA Pilot)
Functional Hypothalamic Amenorrhea
RecruitingPhase 3
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
Hypogonadism, Male
RecruitingPhase 4
Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
Prostate Cancer, Hypogonadism, Male
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

21 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Topical Testosterone Solution in people with Hypogonadism, run by Eli Lilly and Company at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Normal Serum Testosterone Levels (time frame: Baseline through Study Completion (Up to 9 Weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01893281.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2014.