HypogonadismPhase 3NCT01816295

A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and Energy

A Phase 3 study testing Testosterone Solution in people with Hypogonadism, run by Eli Lilly and Company at 85 sites in 9 countries.

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

The main purpose of this study is to evaluate if testosterone solution can raise testosterone hormone levels into the normal range, and also improve levels of sexual arousal, interest and drive and/or energy level, in men with low testosterone and decreased sexual arousal, interest and drive and/or decreased energy. 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?: Testosterone Solution
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 715 participants
Where: 85 sitesin 9 countries
Study dates: May 2013to Apr 2015
Phase: Phase 3
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

Total testosterone level <300 nanogram per deciliter (ng/dL) [10.4 nanomole per Liter (nmol/L)] at each of 2 screening visits
At least 1 symptom of testosterone deficiency, which must include decreased energy or decreased sexual drive
Prostate Specific Antigen (PSA) <4 nanogram per milliliter (ng/ml) at screening

Who cannot join

Sexual partner who is or becomes pregnant at any time during the study
Use of long-acting intramuscular (IM) testosterone undecanoate or testosterone pellets in the 6-month period prior to screening
Body Mass Index (BMI) >37 kilogram per square meter (kg/m^2) at screening
Severe lower urinary tract symptoms and/or significant prostate enlargement
Prolactin lab test result of >30 ng/mL at screening
Hemoglobin A1c (HbA1c) >11% at screening

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Hematocrit ≥50% (>54% at elevated altitude) at screening
Current use of any medications, herbal, and/or nutritional supplements that can interfere with testosterone
Dermatologic condition in underarm area that might interfere with testosterone absorption (for example, eczema) or be exacerbated by topical testosterone replacement therapy
Currently receiving treatment with cancer chemotherapy or antiandrogens
Chronic use of systemic glucocorticoids (use for >14 days within the 3 months prior to screening); use of non-testosterone anabolic steroids within 12 months prior to screening
Competitive athletes involved in a sport in which they may be screened for anabolic steroids
History of use of estrogenizing agents within 12 months prior to screening
History of luteinizing hormone-releasing hormone antagonist or agonist treatment in the last 6 months prior to screening
History of clomiphene or other anti-estrogen treatment in the 3 months prior to screening
Use of finasteride within 3 months prior to screening, or use of dutasteride within 6 months prior to screening
Current use of warfarin or phenprocoumon
History of frequent opioid use: >1 time/week during any week within 30 days prior to screening
Current use of dopamine receptor agonists (cabergoline, pergolide, bromocriptine)
Have a history of significant central nervous system injuries or disease (including stroke, spinal cord injury, or multiple sclerosis) within 6 months prior to screening
Systolic blood pressure >170 or <90 millimeter of mercury (mm Hg) or diastolic blood pressure >100 or <50 mm Hg at screening or a history of malignant hypertension
History of unstable angina as defined by Braunwald Classification of Unstable Angina or angina occurring during sexual intercourse in the last 6 months
History of any of the following coronary conditions within 90 days of screening: myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention (angioplasty or stent placement)
Have any supraventricular arrhythmia with an uncontrolled ventricular response [mean heart rate >100 beats per minute (bpm)] at rest, or have any history of spontaneous or induced sustained ventricular tachycardia (heart rate >100 bpm for ≥30 seconds), or use of an automatic internal cardioverter-defibrillator
Have a history of sudden cardiac arrest
Exhibit any evidence of congestive heart failure [New York Heart Association (NYHA) Class 2 or above], within 6 months prior to screening
Have had a new, significant cardiac conduction defect within 90 days prior to screening
Clinical suspicion (or history) of prostate cancer during digital rectal examination at screening
Known or suspected breast cancer (or history of breast cancer) or other active cancer (with the exception of nonmelanotic skin cancer)
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
Have a history of human immunodeficiency virus (HIV) infection
Severe sleep apnea
Untreated hypothyroidism, hypercortisolism or other significant endocrinopathy (other than hypogonadism) that contributes to symptoms of low energy or fatigue

Trial locations and contacts

85 sites in 9 countries.

Country

City, postcode or hospital

85 sites in 9 countries

United States45 sites

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Austin, Texas
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Bala-Cynwyd, Pennsylvania
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Bellevue, Washington
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Chandler, Arizona
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Clinton, Utah
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Colorado Springs, Colorado
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Columbus, Ohio
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Coral Springs, Florida
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Crystal Lake, Illinois
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Daytona Beach, Florida
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Des Moines, Iowa
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Englewood, New Jersey
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Escondido, California
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Fort Lauderdale, Florida
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Fort Wayne, Indiana
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Glendale, Arizona
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Greenbelt, Maryland
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Greer, South Carolina
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Homewood, Alabama
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Houston, Texas
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Idaho Falls, Idaho
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Indianapolis, Indiana
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Irvine, California
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Jacksonville, Florida
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Kingsport, Tennessee
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Las Vegas, Nevada
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Los Angeles, California
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Meridian, Idaho
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Mesa, Arizona
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Mt. Pleasant, South Carolina
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Oviedo, Florida
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Phoenix, Arizona
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Plantation, Florida
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Raleigh, North Carolina
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Seattle, Washington
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Shreveport, Louisiana
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Spokane, Washington
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Spring Valley, California
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Springfield, Missouri
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St. Petersburg, Florida
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Tempe, Arizona
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Toms River, New Jersey
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Topeka, Kansas
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Tucson, Arizona
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Wilmington, North Carolina

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Canada8 sites

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Barrie, Ontario
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Burlington, Ontario
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Calgary, Alberta
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Kingston, Ontario
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Kitchener, Ontario
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London, Ontario
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Sherbrooke, Quebec
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Victoria, British Columbia

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Italy8 sites

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Ancona
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Bergamo
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Bologna
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Catania
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Florence
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Rome
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Rozzano
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Torino

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Germany7 sites

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Berlin
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Halle
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Hamburg
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Hettstedt
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Holzminden
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Marburg
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Münster

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Spain6 sites

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A Coruña
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Aravaca
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Barcelona
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Coslada
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Madrid
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Majadahonda

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South Korea5 sites

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Goyang-si
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Jeonju
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Kwangju
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Pusan
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Seoul

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United Kingdom3 sites

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Barnsley
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Hathersage Road, Manchester
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London, Greater London

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Argentina2 sites

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Buenos Aires
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Caba

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Puerto Rico1 site

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San Juan

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About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Parallel Study With an Open-Label Extension to Assess the Impact of Testosterone Solution on Total Testosterone, Sex Drive and Energy in Hypogonadal Men

Conditions: Hypogonadism
Being tested: Testosterone Solution, Placebo Solution
Medical subject headings: Hypogonadism

What participants receive

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

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

Study groups in NCT01816295
Study group	Role	What they receive
Placebo Solution	Placebo comparator	Placebo Solution applied topically once daily for 12 weeks. Receives: Drug: Placebo Solution
Testosterone Solution	Experimental	Testosterone Solution 60 milligram (mg) applied topically once daily with possible titration down to 30 milligram per day (mg/day) or up to 120 mg/day for 12 weeks and optional extension for 24 weeks. Receives: Drug: Testosterone Solution

What is being measured

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

Number of Participants With Total Serum Testosterone Concentration Within Normal Range at Week 12
Normal range for total serum testosterone was defined as 300 to 1050 nanograms per deciliter (ng/dL).
Measured: Week 12

Secondary outcomes (3)

Change From Baseline to Week 12 in Sexual Arousal, Interest, and Drive (SAID) Scale Scores
The SAID Scale is a self-administered instrument used to assess sexual arousal, interest, and sex drive in men with symptomatic hypogonadism. The SAID consists of 5 questions that were scored on a scale from 1 to 5, with "5" corresponding to greater levels of sexual arousal, interest, or drive. The SAID Scale total score was computed by summing the item scores and linearly transforming the sum to a 0 to 100 scale, with higher scores corresponding to greater sexual arousal, interest, and drive. Least squares (LS) mean change from baseline was calculated using an analysis of covariance (ANCOVA) with treatment group and the baseline value as covariates.
Measured: Baseline, Week 12
Change From Baseline to Week 12 in Hypogonadism Energy Diary (HED) Scores
The HED is a self-administered instrument used to assess real-time energy levels in men with symptomatic hypogonadism. It consists of 2 questions that were scored on a scale from 0 to 10, with "10" corresponding to "Full of Energy" or "Not Tired at All" (The Tiredness scale was reverse-mapped, as it was collected with "10" corresponding to "Extreme Tiredness"). The questionnaire was completed 3 times daily (forming 6 unique items) for 7 consecutive days. Item scores were computed by averaging the values for each item across 7 days. If more than 2 days were missing for an item, the item score was missing. The total score was computed by summing the item scores and linearly transforming the sum to a 0 to 100 scale, with higher scores corresponding to greater energy. If any item score was missing, the total score was missing. LS mean change from baseline was calculated using ANCOVA with treatment group and the baseline value as covariates.
Measured: Baseline, Week 12
Number of Participants With Prostate Specific Antigen (PSA) >4 Nanogram/Milliliter (ng/mL)
Measured: Double Blind Baseline, Week 12, Open Label Baseline, Week 36

Timeline

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

May 2013Apr 2015

First posted22 Mar 2013 (estimated)
Study startMay 2013
Primary completionOct 2014
Study completionApr 2015

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.
Publications (2)Papers the sponsor has linked to this study.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 715 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01816295
Sponsor's protocol ID: 14396
Other IDs: I5E-MC-TSAT, 2012-004866-16
Status last verified: Nov 2015
First submitted: 19 Mar 2013
Last updated: 28 Dec 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 38224135
Brock G, Heiselman D, Maggi M, Kim SW, Rodriguez Vallejo JM, Behre HM, McGettigan J, Dowsett SA, Hayes RP, Knorr J, Ni X, Kinchen K. Effect of Testosterone Solution 2% on Testosterone Concentration, Sex Drive and Energy in Hypogonadal Men: Results of a Placebo Controlled Study. J Urol. 2016 Mar;195(3):699-705. doi: 10.1016/j.juro.2015.10.083. Epub 2015 Oct 20.
PubMed 26498057

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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All Hypogonadism trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled Parallel Study With an Open-Label Extension to Assess the Impact of Testosterone Solution on Total Testosterone, Sex Drive and Energy in Hypogonadal Men
ClinicalTrials.gov ID: NCT01816295
Acronym / sponsor ID: 14396
Conditions: Hypogonadism
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 715 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: May 2013
Primary completion: Oct 2014 (actual)
Study completion: Apr 2015 (actual)
First posted: 22 Mar 2013 (estimated)
Results: Posted 2 Oct 2015

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: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo Solution	Placebo comparator	Drug: Placebo SolutionPlacebo Solution applied topically once daily for 12 weeks.
Testosterone Solution	Experimental	Drug: Testosterone SolutionTestosterone Solution 60 milligram (mg) applied topically once daily with possible titration down to 30 milligram per day (mg/day) or up to 120 mg/day for 12 weeks and optional extension for 24 weeks.

Who may qualify

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

Key inclusion criteria (3 listed)

Total testosterone level <300 nanogram per deciliter (ng/dL) [10.4 nanomole per Liter (nmol/L)] at each of 2 screening visits
At least 1 symptom of testosterone deficiency, which must include decreased energy or decreased sexual drive
Prostate Specific Antigen (PSA) <4 nanogram per milliliter (ng/ml) at screening

Key exclusion criteria (34 listed)

Sexual partner who is or becomes pregnant at any time during the study
Use of long-acting intramuscular (IM) testosterone undecanoate or testosterone pellets in the 6-month period prior to screening
Body Mass Index (BMI) >37 kilogram per square meter (kg/m^2) at screening
Severe lower urinary tract symptoms and/or significant prostate enlargement
Prolactin lab test result of >30 ng/mL at 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
Testosterone SolutionAlso: Axiron, Testosterone Solution 2%, LY900011Administered topically to axillae.	Drug	Testosterone Solution
Placebo SolutionAdministered topically to axillae.	Drug	Placebo Solution

Primary outcome

Number of Participants With Total Serum Testosterone Concentration Within Normal Range at Week 12
Time frame: Week 12
Normal range for total serum testosterone was defined as 300 to 1050 nanograms per deciliter (ng/dL).

3 secondary outcomes

Change From Baseline to Week 12 in Sexual Arousal, Interest, and Drive (SAID) Scale Scores
Time frame: Baseline, Week 12
Change From Baseline to Week 12 in Hypogonadism Energy Diary (HED) Scores
Time frame: Baseline, Week 12
Number of Participants With Prostate Specific Antigen (PSA) >4 Nanogram/Milliliter (ng/mL)
Time frame: Double Blind Baseline, Week 12, Open Label Baseline, Week 36

Results and safety

Results posted to the registry on 2 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Solution	357	294
Testosterone Solution	358	302

Primary outcome: Number of Participants With Total Serum Testosterone Concentration Within Normal Range at Week 12

Time frame: Week 12. Number. Unit: participants

Measure	Placebo Solution n = 287	Testosterone Solution n = 297
Value	43	217

Placebo Solution vs Testosterone Solution: p <0.001, Chi-squared

Population analysed: All randomized participants who completed 12 weeks of treatment and had non-missing testosterone concentration at week 12.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Solution - Double Blind	8 of 356 (2.2%)	143 of 356 (40.2%)	Not reported
Testosterone Solution - Double Blind	4 of 354 (1.1%)	148 of 354 (41.8%)	Not reported
Testosterone Solution - OLE	24 of 558 (4.3%)	252 of 558 (45.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38224135Lee 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.
Derived from this study: PubMed 26498057Brock G, Heiselman D, Maggi M, Kim SW, Rodriguez Vallejo JM, Behre HM, McGettigan J, Dowsett SA, Hayes RP, Knorr J, Ni X, Kinchen K. Effect of Testosterone Solution 2% on Testosterone Concentration, Sex Drive and Energy in Hypogonadal Men: Results of a Placebo Controlled Study. J Urol. 2016 Mar;195(3):699-705. doi: 10.1016/j.juro.2015.10.083. Epub 2015 Oct 20.

Related trials for Hypogonadism

RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship
Not yet recruitingObservational study
Hematological Profile in Children With Numerical Chromosomal Disorders
Down Syndrome, Turner Syndrome
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 3
Safety and Efficacy of Weekly Testosterone Cypionate Auto-Injector in Men With Hypogonadism
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RecruitingObservational study
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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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

85 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Testosterone Solution in people with Hypogonadism, run by Eli Lilly and Company at 85 sites in 9 countries.

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 3 inclusion and 34 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 28 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in United States, Canada, Italy, Germany, Spain and 4 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 2 Oct 2015). 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?

Number of Participants With Total Serum Testosterone Concentration Within Normal Range at Week 12 (time frame: Week 12). 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 NCT01816295, which also lists 2 linked publications.

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 28 Dec 2015.