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CompletedNCT00702650Updated Jul 25, 2011Results posted

A Titration Trial to Determine the Effectiveness of Testosterone MD-Lotion (Cutaneous Solution) Formulations

A Phase 3 interventional study of Testosterone MD-Lotion in Hypogonadism, sponsored by Eli Lilly and Company. Completed at 27 sites in 6 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-07-25.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
155
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study summary

Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product- Testosterone MD-Lotion (cutaneous solution), and this study will evaluate the efficacy via pharmacokinetics of various doses of this product. The study will also assess safety of the product.

02

Conditions studied

  • Hypogonadism

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03

In context

Hypogonadism

345 studies on the registry are indexed under Hypogonadism; 43 are open to participants now.

This study's enrollment of 155 is above the median of 56 across 260 interventional studies indexed under Hypogonadism.

Browse Hypogonadism studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Male subjects with a prior documented definitive diagnosis of hypogonadism as evidenced by previously documented:

    • Hypothalamic, pituitary or testicular disorder or age related idiopathic hypogonadism
    • Screening serum testosterone of less than or equal to 300 ng/dL (based on the average of two morning samples taken at least 30 minutes apart)
  • Were currently receiving treatment for hypogonadism in accordance with approved labelling, or in the Investigator's opinion are eligible to receive such treatment
  • Body Mass Index (BMI) \< 35.0 kg/m\^2
  • Haemoglobin levels at screening greater than or equal to 11.5 g/dL
  • Adequate venous access on left or right arm to allow collection of a number of samples by venipuncture
  • Ability to communicate with the trial staff, understand the Trial Information Sheet and sign the Written Informed Consent Forms; willing to follow the Protocol requirements and comply with Protocol restrictions and procedures

Exclusion criteria

Exclusion Criteria:

  • Current use of long acting testosterone injectables such as Nebido®
  • Any significant history of allergy and/or sensitivity to the drug products or their excipients, including any history of sensitivity to testosterone and/or sunscreens
  • Any clinically significant chronic illness or finding on screening physical exam and/or laboratory testing that makes it undesirable for the Investigator to enrol the trial subject in the trial and/or that in the Investigator's opinion, would interfere with the trial objectives or safety of the subject
  • Chronic skin disorder (e.g. eczema, psoriasis) likely to interfere with transdermal drug absorption
  • Men with suspected reversible hypogonadism

  • Any man in whom testosterone therapy was contraindicated, which included those with:

    • Known or suspected carcinoma (or history of carcinoma) of the prostate or clinically significant symptoms of benign prostatic hyperplasia and/or clinically significant symptoms of lower urinary obstruction and International Prostate Symptom Scores (IPSS) scores of greater than or equal to 19
    • Known or suspected carcinoma (or history of carcinoma) of the breast
    • Severe liver disease (i.e. cirrhosis, hepatitis or liver tumours or liver function tests >2 times the upper limit of the normal range values)
    • Active deep vein thrombosis, thromboembolic disorders or a documented history of these conditions
    • Current significant cerebrovascular or coronary artery disease
    • Untreated sleep apnoea
    • Haematocrit of > 51
    • Untreated moderate to severe depression
  • Men with clinically significant prostate exam (such as irregularities or nodules palpated) or clinically significant elevated serum Prostate Specific Antigen (PSA) levels (>4 ng/mL), or age adjusted reference range of PSA values
  • Current or history of drug or alcohol abuse (more than 4 standard drinks per day and/or abnormal liver function tests >2 times the upper limit of the normal range values)
  • Men taking concomitant medications (prescribed, over-the-counter or complementary) that would affect sex hormone binding globulin (SHBG) or testosterone concentrations or metabolism, warfarin, insulin, opiates, Gonadotropin-releasing hormone (GnRH), 5 alpha reductase inhibitors, propanolol, oxyphenbutazone, corticosteroids (except for physiological replacement doses), estradiol
  • Men involved in sport in which there is screening for anabolic steroids
  • Men with uncontrolled diabetes (haemoglobin A1c [HbA1c] greater than or equal to 10%)
  • Men currently taking any investigational product, or have received an investigational product within 28 days prior to screening or 5 half-lives
  • Any contraindication to blood sampling
  • Subjects intending to have any surgical procedure during the course of the trial
  • Subjects with a partner of child bearing potential who are not willing to use adequate contraception for the duration of the trial
  • Subjects whose partners are pregnant
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
155 participants (actual)

Study arms

  • Experimental
    Testosterone MD-Lotion

    Participants received Testosterone Metered Dose (MD)-Lotion for 120 days. Participants started by receiving 3.0 mL (60 mg) of 2% Testosterone MD-Lotion, and based upon restoration to eugonadal levels, may have had their dose of testosterone adjusted upwards or downwards on Days 45 and 90. Doses could be titrated to one of the following: 1.5 mL (30 mg) of 2% Testosterone MD-Lotion applied daily by 1 dose to the axilla (1.5 mL to one axilla). 3.0 mL (60 mg) of 2% Testosterone MD-Lotion applied daily by 2 doses to the axilla (1.5 mL to each axilla). 4.5 mL (90 mg) of 2% Testosterone MD-Lotion applied daily by 3 doses to the axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla). 6.0 mL (120 mg) of 2% Testosterone MD-Lotion applied daily by 4 doses to the axilla (2 x 1.5 mL to each axilla).

    Drug: Testosterone MD-Lotion

Interventions

  • DrugTestosterone MD-Lotion

    30 mg to 120 mg administered topically once daily for 120 days

    Also known as: LY900011, Axiron

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With 24-Hour Average Concentration [Cavg(0-24h)] Total Testosterone Within Normal Range at Day 120

    Cavg(0-24) is the average serum concentration calculated over the 24 hour period on Day 120. Calculated as the AUC(0-24) divided by 24 hours. Normal range for Total Testosterone was defined as 300 - 1050 nanograms per deciliter (ng/dL).

    Time frame: Day 120

Secondary outcomes

  1. Percentage of Participants With Maximum Serum Concentration (Cmax) >1500 ng/dL

    Cmax is the maximum observed serum concentration (\>1500 ng/dL) during the 24 hour period on Day 120.

    Time frame: Day 120

  2. Percentage of Participants With Cmax Between 1800 and 2500 ng/dL

    Cmax is the maximum observed serum concentration (between 1800 and 2500 ng/dL) during the 24 hour period on Day 120.

    Time frame: Day 120

  3. Percentage of Participants With Cmax >2500 ng/dL

    Cmax is the maximum observed serum concentration (\>2500 ng/dL) during the 24 hour period on Day 120.

    Time frame: Day 120

  4. Percentage of Participants With Minimum Concentration (Cmin) <300 ng/dL

    Cmin is the minimum observed serum concentration (\<300 ng/dL) during the 24 hour period on Day 120.

    Time frame: Day 120

  5. Change From Baseline to Endpoint in Psychosexual Daily Questionnaire

    Questions included: Sexual Desire (0=none to 7=very high), Overall Sexual Activity Score (calculated as average of weekly values on scale from 0=none to 7=Frequent), Erection Maintained for Satisfactory Duration (0=not satisfactory to 7=very satisfactory), and Positive and Negative Mood (individual mood variables on scale from 0=Not at all true to 7=very true). Positive mood: sum of 4 positive mood variables-alert, full of pep/energetic, friendly, and well/good (range from 0-28). Negative mood: sum of 5 negative mood variables-angry, irritable, sad/blue, tired, and nervous (range from 0-35).

    Time frame: Baseline, Day 120

  6. Change From Baseline to Endpoint in the 36-Item Short-Form Health Survey (SF-36)

    The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). MCS and PCS scores=0-100 (higher scores indicate better health status).

    Time frame: Baseline, Day 120

  7. Change From Baseline to Endpoint in Fasting Insulin

    Time frame: Baseline, up to Day 120

  8. Change From Baseline to Endpoint in Fasting Glucose

    Time frame: Baseline, up to Day 120

  9. Change From Baseline to Endpoint in Prostate Specific Antigen (PSA)

    Time frame: Baseline, Day 120

  10. Change From Baseline to Endpoint in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)

    Time frame: Baseline, up to Day 120

  11. Change From Baseline to Endpoint in Estradiol

    Time frame: Baseline, up to Day 120

  12. Change From Baseline to Endpoint in Haemoglobin

    Time frame: Baseline, up to Day 120

  13. Change From Baseline to Endpoint in Haematocrit

    Haematocrit: percentage of total blood volume made up of blood cells

    Time frame: Baseline, up to Day 120

  14. Change From Baseline to Endpoint in Draize Score

    Draize score is a measurement of skin irritability of the application site based on erythema/eschar and oedema. Erythema/eschar scoring ranges from 0 (no erythema) to 4 (severe erythema \[beet redness\] to slight eschar formation \[injuries in depth\]). Oedema scoring ranges from 0 (no oedema) to 4 (severe oedema \[raised more than 1 millimeter and extending beyond area of exposure\]. The total Draize score ranges from 0 to 8.

    Time frame: Baseline, Day 120

07

Results

Posted Jan 5, 2011

Participant flow

Participant flow — Overall Study
MilestoneTestosterone MD-Lotion
Started155
Completed135
Not completed20
Withdrew: Withdrawal by subject9
Withdrew: Non-compliance of study drug3
Withdrew: Lost to follow-up2
Withdrew: Non-compliance with site directives1
Withdrew: Sponsor request1
Withdrew: Screening testosterone levels >300 ng/dl1
Withdrew: Adverse event3

Outcome measures

PrimaryPercentage of Participants With 24-Hour Average Concentration [Cavg(0-24h)] Total Testosterone Within Normal Range at Day 120

Cavg(0-24) is the average serum concentration calculated over the 24 hour period on Day 120. Calculated as the AUC(0-24) divided by 24 hours. Normal range for Total Testosterone was defined as 300 - 1050 nanograms per deciliter (ng/dL).

Time frame:
Day 120
Reported as:
Number · percentage of participants
Percentage of Participants With 24-Hour Average Concentration [Cavg(0-24h)] Total Testosterone Within Normal Range at Day 120
percentage of participantsTestosterone MD-Lotion
Percentage of Participants With 24-Hour Average Concentration [Cavg(0-24h)] Total Testosterone Within Normal Range at Day 12084.1 (77.95 to 90.17)
Statistical analysis
  • Testosterone MD-Lotion · One-Sample Binomial (Wald) test, 2-sided · p = <0.001
SecondaryPercentage of Participants With Maximum Serum Concentration (Cmax) >1500 ng/dL

Cmax is the maximum observed serum concentration (\>1500 ng/dL) during the 24 hour period on Day 120.

Time frame:
Day 120
Reported as:
Number · percentage of participants
Percentage of Participants With Maximum Serum Concentration (Cmax) >1500 ng/dL
percentage of participantsTestosterone MD-Lotion
Percentage of Participants With Maximum Serum Concentration (Cmax) >1500 ng/dL5.2
SecondaryPercentage of Participants With Cmax Between 1800 and 2500 ng/dL

Cmax is the maximum observed serum concentration (between 1800 and 2500 ng/dL) during the 24 hour period on Day 120.

Time frame:
Day 120
Reported as:
Number · percentage of participants
Percentage of Participants With Cmax Between 1800 and 2500 ng/dL
percentage of participantsTestosterone MD-Lotion
Percentage of Participants With Cmax Between 1800 and 2500 ng/dL3.0
SecondaryPercentage of Participants With Cmax >2500 ng/dL

Cmax is the maximum observed serum concentration (\>2500 ng/dL) during the 24 hour period on Day 120.

Time frame:
Day 120
Reported as:
Number · percentage of participants
Percentage of Participants With Cmax >2500 ng/dL
percentage of participantsTestosterone MD-Lotion
Percentage of Participants With Cmax >2500 ng/dL0.7
SecondaryPercentage of Participants With Minimum Concentration (Cmin) <300 ng/dL

Cmin is the minimum observed serum concentration (\<300 ng/dL) during the 24 hour period on Day 120.

Time frame:
Day 120
Reported as:
Number · percentage of participants
Percentage of Participants With Minimum Concentration (Cmin) <300 ng/dL
percentage of participantsTestosterone MD-Lotion
Percentage of Participants With Minimum Concentration (Cmin) <300 ng/dL64.4
SecondaryChange From Baseline to Endpoint in Psychosexual Daily Questionnaire

Questions included: Sexual Desire (0=none to 7=very high), Overall Sexual Activity Score (calculated as average of weekly values on scale from 0=none to 7=Frequent), Erection Maintained for Satisfactory Duration (0=not satisfactory to 7=very satisfactory), and Positive and Negative Mood (individual mood variables on scale from 0=Not at all true to 7=very true). Positive mood: sum of 4 positive mood variables-alert, full of pep/energetic, friendly, and well/good (range from 0-28). Negative mood: sum of 5 negative mood variables-angry, irritable, sad/blue, tired, and nervous (range from 0-35).

Time frame:
Baseline, Day 120
Reported as:
Mean · units on a scale
Change From Baseline to Endpoint in Psychosexual Daily Questionnaire
units on a scaleTestosterone MD-Lotion
Sexual Desire1.49 ± 1.84
Overall Sexual Activity Score0.94 ± 1.43
Erection Maintained for Satisfactory Duration1.11 ± 2.0
Positive Mood0.56 ± 1.25
Negative Mood-0.50 ± 1.33
Statistical analysis
  • Testosterone MD-Lotion · t-test, 2 sided · p = <0.0001 (P-value is for Sexual Desire based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.)
  • Testosterone MD-Lotion · t-test, 2 sided · p = <0.0001 (P-value is for Overall Sexual Activity Score based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.)
  • Testosterone MD-Lotion · t-test, 2 sided · p = <0.0001 (P-value is for Erection Maintained for Satisfactory Duration based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.)
  • Testosterone MD-Lotion · t-test, 2 sided · p = <0.0001 (P-value is for Positive Mood based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.)
  • Testosterone MD-Lotion · t-test, 2 sided · p = <0.0001 (P-value is for Negative Mood based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.)
SecondaryChange From Baseline to Endpoint in the 36-Item Short-Form Health Survey (SF-36)

The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). MCS and PCS scores=0-100 (higher scores indicate better health status).

Time frame:
Baseline, Day 120
Reported as:
Mean · units on a scale
Change From Baseline to Endpoint in the 36-Item Short-Form Health Survey (SF-36)
units on a scaleTestosterone MD-Lotion
Physical Component Score1.55 ± 7.72
Mental Component Score4.54 ± 9.20
Statistical analysis
  • Testosterone MD-Lotion · t-test, 2 sided · p = 0.0254 (p-value for Physical Component Score based on a one-sample t-test comparing Day 120 and Baseline values.)
  • Testosterone MD-Lotion · t-test, 2 sided · p = <0.0001 (p-value for Mental Component Score based on a one-sample t-test comparing Day 120 and Baseline values.)
SecondaryChange From Baseline to Endpoint in Fasting Insulin
Time frame:
Baseline, up to Day 120
Reported as:
Mean · uIU/mL
Change From Baseline to Endpoint in Fasting Insulin
uIU/mLTestosterone MD-Lotion
Change From Baseline to Endpoint in Fasting Insulin1.93 ± 12.02
SecondaryChange From Baseline to Endpoint in Fasting Glucose
Time frame:
Baseline, up to Day 120
Reported as:
Mean · mg/dL
Change From Baseline to Endpoint in Fasting Glucose
mg/dLTestosterone MD-Lotion
Change From Baseline to Endpoint in Fasting Glucose-0.41 ± 20.02
SecondaryChange From Baseline to Endpoint in Prostate Specific Antigen (PSA)
Time frame:
Baseline, Day 120
Reported as:
Mean · ng/mL
Change From Baseline to Endpoint in Prostate Specific Antigen (PSA)
ng/mLTestosterone MD-Lotion
Change From Baseline to Endpoint in Prostate Specific Antigen (PSA)0.13 ± 0.68
SecondaryChange From Baseline to Endpoint in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)
Time frame:
Baseline, up to Day 120
Reported as:
Mean · mIU/mL
Change From Baseline to Endpoint in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)
mIU/mLTestosterone MD-Lotion
Luteinizing Hormone (N=48)-2.04 ± 5.36
Follicle Stimulating Hormone (N=54)-2.41 ± 9.72
SecondaryChange From Baseline to Endpoint in Estradiol
Time frame:
Baseline, up to Day 120
Reported as:
Mean · pg/mL
Change From Baseline to Endpoint in Estradiol
pg/mLTestosterone MD-Lotion
Change From Baseline to Endpoint in Estradiol-2.16 ± 12.32
SecondaryChange From Baseline to Endpoint in Haemoglobin
Time frame:
Baseline, up to Day 120
Reported as:
Mean · g/dL
Change From Baseline to Endpoint in Haemoglobin
g/dLTestosterone MD-Lotion
Change From Baseline to Endpoint in Haemoglobin0.51 ± 1.08
SecondaryChange From Baseline to Endpoint in Haematocrit

Haematocrit: percentage of total blood volume made up of blood cells

Time frame:
Baseline, up to Day 120
Reported as:
Mean · percentage of red blood cells
Change From Baseline to Endpoint in Haematocrit
percentage of red blood cellsTestosterone MD-Lotion
Change From Baseline to Endpoint in Haematocrit0.02 ± 0.04
SecondaryChange From Baseline to Endpoint in Draize Score

Draize score is a measurement of skin irritability of the application site based on erythema/eschar and oedema. Erythema/eschar scoring ranges from 0 (no erythema) to 4 (severe erythema \[beet redness\] to slight eschar formation \[injuries in depth\]). Oedema scoring ranges from 0 (no oedema) to 4 (severe oedema \[raised more than 1 millimeter and extending beyond area of exposure\]. The total Draize score ranges from 0 to 8.

Time frame:
Baseline, Day 120
Reported as:
Mean · units on a scale
Change From Baseline to Endpoint in Draize Score
units on a scaleTestosterone MD-Lotion
Change From Baseline to Endpoint in Draize Score0 ± 0.17

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Testosterone MD-Lotion—1/155 (0.6%)80/155 (51.6%)
Most frequent serious events
Most frequent serious events
EventTestosterone MD-Lotion
AppendicitisInfections and infestations1/155
Most frequent other events
Showing 10 of 40
Most frequent other events
EventTestosterone MD-Lotion
Application site irritationGeneral disorders11/155
Application site erythemaGeneral disorders8/155
HeadacheNervous system disorders8/155
NasopharyngitisInfections and infestations6/155
Haematocrit increasedInvestigations6/155
DiarrhoeaGastrointestinal disorders4/155
VomitingGastrointestinal disorders4/155
FatigueGeneral disorders3/155
PyrexiaGeneral disorders3/155
InfluenzaInfections and infestations3/155

Baseline characteristics

Age Continuous
Age Continuous(years)Testosterone MD-Lotion
Mean51.5 ± 12.7
Sex: Female, Male
Sex: Female, Male(Participants)Testosterone MD-Lotion
Female0
Male155
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Testosterone MD-Lotion
Asian1
Caucasian122
African American6
Hispanic13
Other - Not Specified2
Missing11
Region of Enrollment
Region of Enrollment(participants)Testosterone MD-Lotion
France11
United States104
Australia10
Germany9
United Kingdom10
Sweden11
Body Mass Index (BMI)
Body Mass Index (BMI)(kilograms per square meter (kg/m^2))Testosterone MD-Lotion
Mean29.53 ± 3.60
Baseline Total Testosterone Level
Baseline Total Testosterone Level(nanograms per deciliter (ng/dL))Testosterone MD-Lotion
Mean196.73 ± 91.04
08

Study locations

27 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.
    Birmingham, Alabama, United States
  • 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.
    Tuscon, Arizona, United States
  • 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.
    Burbank, California, United States
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    Torrance, California, United States
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    Colorado Springs, Colorado, United States
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    New Britain, Connecticut, United States
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    Ocala, Florida, United States
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    Boise, Idaho, United States
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    Shawnee Mission, Kansas, United States
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    Shreveport, Louisiana, United States
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    Omaha, Nebraska, United States
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    San Antonio, Texas, United States
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    Sydney, New South Wales, Australia
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    Adelaide, South Australia, Australia
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    Melbourne, Victoria, Australia
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    Perth, Western Australia, Australia
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    Lyon, France
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    Nice, France
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    Nimes, France
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    Bonn, Germany
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    Freiburg, Germany
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    Halle, Germany
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    Malmo, Sweden
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    Stockholm, Sweden
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    Barnsley, United Kingdom
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    Newcastle Upon Tyne, United Kingdom
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    Swansea, United Kingdom
09

References and documents

Publications

  • Wang C, Ilani N, Arver S, McLachlan RI, Soulis T, Watkinson A. Efficacy and safety of the 2% formulation of testosterone topical solution applied to the axillae in androgen-deficient men. Clin Endocrinol (Oxf). 2011 Dec;75(6):836-43. doi: 10.1111/j.1365-2265.2011.04152.x. PubMed 21689131 ↗
  • Muram D, Ni X. Utility of a single serum testosterone measurement to determine response to topical testosterone replacement in hypogonadal men. Curr Med Res Opin. 2016;32(2):263-9. doi: 10.1185/03007995.2015.1117434. Epub 2015 Dec 15. PubMed 26549704 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00702650
Lead sponsor
Eli Lilly and Company
First posted
Jun 20, 2008
Start date
Jun 2008
Primary completion
Jul 2009
Completion
Jul 2009
Results posted
Jan 5, 2011
Last update
Jul 25, 2011

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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