NCT01816295

Brief 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. The study will last about 16 weeks, followed by an optional 24 week open label treatment phase to investigate the long term safety of testosterone solution.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
715

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2013

Geographic Reach
9 countries

85 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

First Submitted

Initial submission to the registry

March 19, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 22, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
6 months until next milestone

Results Posted

Study results publicly available

October 2, 2015

Completed
Last Updated

December 28, 2015

Status Verified

November 1, 2015

Enrollment Period

1.4 years

First QC Date

March 19, 2013

Results QC Date

September 1, 2015

Last Update Submit

November 24, 2015

Conditions

Hypogonadism

Outcome Measures

Primary Outcomes (1)

  • 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).

    Week 12

Secondary Outcomes (3)

  • Change From Baseline to Week 12 in Sexual Arousal, Interest, and Drive (SAID) Scale Scores

    Baseline, Week 12

  • Change From Baseline to Week 12 in Hypogonadism Energy Diary (HED) Scores

    Baseline, Week 12

  • Number of Participants With Prostate Specific Antigen (PSA) >4 Nanogram/Milliliter (ng/mL)

    Double Blind Baseline, Week 12, Open Label Baseline, Week 36

Other Outcomes (1)

  • Change From Baseline in Total International Prostate Symptom Score (IPSS)

    Baseline, Week 12, Week 36

Study Arms (2)

Placebo Solution

PLACEBO COMPARATOR

Placebo Solution applied topically once daily for 12 weeks.

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.

Drug: Testosterone Solution

Interventions

Testosterone SolutionDRUG

Administered topically to axillae.

Also known as: Axiron, Testosterone Solution 2%, LY900011
Testosterone Solution
Placebo SolutionDRUG

Administered topically to axillae.

Placebo Solution

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (85)

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Homewood, Alabama, United States

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Chandler, Arizona, United States

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Glendale, Arizona, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Tempe, Arizona, United States

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Tucson, Arizona, United States

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Escondido, California, United States

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Irvine, California, United States

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Los Angeles, California, United States

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Spring Valley, California, United States

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Colorado Springs, Colorado, United States

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Coral Springs, Florida, United States

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Daytona Beach, Florida, United States

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Fort Lauderdale, Florida, United States

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Jacksonville, Florida, United States

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Oviedo, Florida, United States

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Plantation, Florida, United States

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St. Petersburg, Florida, United States

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Idaho Falls, Idaho, United States

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Meridian, Idaho, United States

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Crystal Lake, Illinois, United States

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Fort Wayne, Indiana, United States

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Indianapolis, Indiana, United States

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Des Moines, Iowa, United States

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Topeka, Kansas, United States

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Shreveport, Louisiana, United States

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Greenbelt, Maryland, United States

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Springfield, Missouri, United States

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Las Vegas, Nevada, United States

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Englewood, New Jersey, United States

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Toms River, New Jersey, United States

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Raleigh, North Carolina, United States

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Wilmington, North Carolina, United States

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Columbus, Ohio, United States

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Bala-Cynwyd, Pennsylvania, United States

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Greer, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Kingsport, Tennessee, United States

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Austin, Texas, United States

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Houston, Texas, United States

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Clinton, Utah, United States

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Bellevue, Washington, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Buenos Aires, Argentina

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Caba, Argentina

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Calgary, Alberta, Canada

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Victoria, British Columbia, Canada

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Barrie, Ontario, Canada

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Burlington, Ontario, Canada

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Kingston, Ontario, Canada

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Kitchener, Ontario, Canada

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London, Ontario, Canada

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Sherbrooke, Quebec, Canada

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Berlin, Germany

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Halle, Germany

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Hamburg, Germany

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Hettstedt, Germany

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Holzminden, Germany

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Marburg, Germany

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Münster, Germany

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Ancona, Italy

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Bergamo, Italy

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Bologna, Italy

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Catania, Italy

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Florence, Italy

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Rome, Italy

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Rozzano, Italy

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Torino, Italy

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San Juan, Puerto Rico

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Goyang-si, South Korea

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Jeonju, South Korea

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Kwangju, South Korea

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Pusan, South Korea

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Seoul, South Korea

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A Coruña, Spain

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Aravaca, Spain

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Barcelona, Spain

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Coslada, Spain

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Madrid, Spain

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Majadahonda, Spain

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London, Greater London, United Kingdom

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Hathersage Road, Manchester, United Kingdom

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Barnsley, United Kingdom

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

  • 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.

    PMID: 26498057DERIVED

MeSH Terms

Conditions

Hypogonadism

Interventions

Testosterone Propionate

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

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 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2013

First Posted

March 22, 2013

Study Start

May 1, 2013

Primary Completion

October 1, 2014

Study Completion

April 1, 2015

Last Updated

December 28, 2015

Results First Posted

October 2, 2015

Record last verified: 2015-11

Locations

DE(7)US(45)PR(1)KR(5)AR(2)ES(6)CA(8)IT(8)GB(3)