HypogonadismPhase 2NCT00857961

A Study of the Pharmacokinetics of Testosterone Metered Dose (MD)-Lotion Formulations

A Phase 2 study testing Testosterone MD-Lotion in people with Hypogonadism, run by Eli Lilly and Company at 4 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

Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study will evaluate pharmacokinetics of testosterone MD-Lotion formulations.The study will also assess safety of the product. Read more about this study

Who is it for?: Ages 18 to 70 years, men only
Conditions the study is for: Hypogonadism
What is being tested?: Testosterone MD-Lotion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 4 sitesUnited States
Study dates: Oct 2007to Jan 2008
Phase: Phase 2
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 to 70 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Male study participants with a prior documented diagnosis of hypoandrogenism as evidenced by previously documented: Hypothalamic, pituitary or testicular disorder or a Serum testosterone less than or equal to 300 ng/dL
Were receiving, or in the investigator's opinion were eligible to receive treatment for hypoandrogenism
Body Mass Index (BMI) less than 35 kg/m^2
Passed the required laboratory and physical screening tests
Haemoglobin levels at screening greater than or equal to 13.0 g/dL
Adequate venous access on left or right arm
Able to communicate with study staff, understand the study information sheet and sign the written Informed Consent forms; willing to follow and comply with study procedures

Who cannot join

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
Chronic skin disorder (e.g. eczema, psoriasis) likely to interfere with transdermal drug absorption
Men with suspected reversible hypoandrogenism (i.e. due to medications, stress)
Any man in whom testosterone therapy is contraindicated, which included those with:
Known or suspected carcinoma (or history of carcinoma) of the prostate or symptoms of benign prostatic hyperplasia and/or symptoms of lower urinary obstruction,

Show all 22Show fewer

Known or suspected carcinoma (or history of carcinoma) of the breast,
Severe liver damage i.e. cirrhosis, hepatitis or liver tumours,
Active deep vein thrombosis, thromboembolic disorders or a documented history of these conditions,
Significant cerebrovascular or coronary artery disease,
Known or suspected sleep apnoea,
Hematocrit > 51%
Men with clinically significant prostate exam or clinically significant elevated serum prostate specific antigen (PSA) level, or age adjusted reference range of PSA values.
Current history of drug or alcohol abuse (more than 4 standard drinks per day and/or abnormal liver function tests 3 times the upper limit of the normal range values)
Men taking concomitant medications that affect sex hormone binding globulin (SHBG) or testosterone concentrations or metabolism, or that were cytochrome P450 inducers or inhibitors, anti-coagulants (warfarin), or diabetic medications (insulin), anti-histamines
Men involved in sport in which there was screening for anabolic steroids
Men with uncontrolled diabetes (hemoglobin A1c [HbA1c] greater than or equal to 10%)
Men taking any Investigational Product, or who had received an Investigational Product within 28 days prior to screening or 5 half-lives (whichever was the longer)
Any contraindication to blood sampling
Study participants who planned to have a surgical procedure during the course of the study
Study participants with a partner of child bearing potential who was not willing to use adequate contraception (i.e. condoms) for the duration of the study
Study participants whose partners were pregnant

Trial locations and contacts

4 sites in 1 country.

United States4 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.
Burbank, California
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.
New Britain, Connecticut
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
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

Other trials in United States

About this study

Official title: A Phase II, Randomised, Four-way Crossover Study to Compare the Steady State Pharmacokinetics of Testosterone Following Application of Different Testosterone Metered Dose (MD) Lotion® Formulations and Doses in Hypogonadal Men

Conditions: Hypogonadism
Being tested: Testosterone MD-Lotion
Medical subject headings: Hypogonadism

What participants receive

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

Testosterone MD-LotionDrug
Also called LY900011, Axiron
Administered Topically

Study groups in NCT00857961
Study group	Role	What they receive
3 mL (30 mg) of 1% Testosterone MD-Lotion	Experimental	Applied once daily for 7 days to both axilla (1.5 mL to each axilla). All study participants are randomized to each of the 4 study treatments. Receives: Drug: Testosterone MD-Lotion
1.5 mL (30 mg) of 2% Testosterone MD-Lotion	Experimental	Applied once daily for 7 days to one axilla. All study participants are randomized to each of the 4 study treatments. Receives: Drug: Testosterone MD-Lotion
3 mL (60 mg) of 2% Testosterone MD-Lotion	Experimental	Applied once daily for 7 days to both axilla (1.5 mL to each axilla). All study participants are randomized to each of the 4 study treatments. Receives: Drug: Testosterone MD-Lotion
4.5 mL (90 mg) of 2% Testosterone MD-Lotion	Experimental	Applied once daily for 7 days by three doses to both axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla). All study participants are randomized to each of the 4 study treatments. Receives: Drug: Testosterone MD-Lotion

What is being measured

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

Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax)
Tmax is the time at which the maximum concentration (Cmax) was attained during the 24 hour period on Day 7.
Measured: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
Pharmacokinetics of Total Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)
Cmax is the maximum observed serum concentration of total testosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.
Measured: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)
Cmax is the maximum observed serum concentration of dihydrotestosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.
Measured: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)
Cmax is the maximum observed serum concentration of free testosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.
Measured: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Degree of Fluctuation (DF)
Degree of fluctuation in serum concentration calculated as ((Cmax-Cmin)/Cavg) x 100%.
Measured: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Area Under the Time Concentration Curve [AUC(0-24h)]
Area under the serum concentration versus time curve was calculated using the linear trapezoidal rule from time 0 to 24 hours on Day 7.
Measured: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment

Secondary outcomes (1)

Number of Participants With Adverse Events
A listing of adverse events is located in the Reported Adverse Events module.
Measured: Baseline through 7 days of each cycle of four treatments and follow-up (up to 38 days)

Timeline

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

Oct 2007Jan 2008

First posted9 Mar 2009 (estimated)
Study startOct 2007
Primary completionJan 2008
Study completionJan 2008

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00857961
Sponsor's protocol ID: 14271
Other IDs: MTE07, I5E-MC-TSAG
Status last verified: Jan 2011
First submitted: 4 Mar 2009
Last updated: 7 Jan 2011
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

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

All Hypogonadism trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomised, Four-way Crossover Study to Compare the Steady State Pharmacokinetics of Testosterone Following Application of Different Testosterone Metered Dose (MD) Lotion® Formulations and Doses in Hypogonadal Men
ClinicalTrials.gov ID: NCT00857961
Acronym / sponsor ID: 14271
Conditions: Hypogonadism
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Jan 2008 (actual)
Study completion: Jan 2008 (actual)
First posted: 9 Mar 2009 (estimated)
Results: Posted 7 Jan 2011

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: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
3 mL (30 mg) of 1% Testosterone MD-Lotion	Experimental	Drug: Testosterone MD-LotionApplied once daily for 7 days to both axilla (1.5 mL to each axilla). All study participants are randomized to each of the 4 study treatments.
1.5 mL (30 mg) of 2% Testosterone MD-Lotion	Experimental	Drug: Testosterone MD-LotionApplied once daily for 7 days to one axilla. All study participants are randomized to each of the 4 study treatments.
3 mL (60 mg) of 2% Testosterone MD-Lotion	Experimental	Drug: Testosterone MD-LotionApplied once daily for 7 days to both axilla (1.5 mL to each axilla). All study participants are randomized to each of the 4 study treatments.
4.5 mL (90 mg) of 2% Testosterone MD-Lotion	Experimental	Drug: Testosterone MD-LotionApplied once daily for 7 days by three doses to both axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla). All study participants are randomized to each of the 4 study treatments.

Who may qualify

Ages: 18 to 70 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Male study participants with a prior documented diagnosis of hypoandrogenism as evidenced by previously documented: Hypothalamic, pituitary or testicular disorder or a Serum testosterone less than or equal to 300 ng/dL
Were receiving, or in the investigator's opinion were eligible to receive treatment for hypoandrogenism
Body Mass Index (BMI) less than 35 kg/m^2
Passed the required laboratory and physical screening tests
Haemoglobin levels at screening greater than or equal to 13.0 g/dL

Key exclusion criteria (22 listed)

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
Chronic skin disorder (e.g. eczema, psoriasis) likely to interfere with transdermal drug absorption
Men with suspected reversible hypoandrogenism (i.e. due to medications, stress)
Any man in whom testosterone therapy is contraindicated, which included those with:

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 MD-LotionAlso: LY900011, AxironAdministered Topically	Drug	1.5 mL (30 mg) of 2% Testosterone MD-Lotion, 3 mL (30 mg) of 1% Testosterone MD-Lotion, 3 mL (60 mg) of 2% Testosterone MD-Lotion, 4.5 mL (90 mg) of 2% Testosterone MD-Lotion

Primary outcome

Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax)
Time frame: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
Tmax is the time at which the maximum concentration (Cmax) was attained during the 24 hour period on Day 7.
Pharmacokinetics of Total Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)
Time frame: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
Cmax is the maximum observed serum concentration of total testosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.
Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)
Time frame: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
Cmax is the maximum observed serum concentration of dihydrotestosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.
Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)
Time frame: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
Cmax is the maximum observed serum concentration of free testosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.
Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Degree of Fluctuation (DF)
Time frame: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
Degree of fluctuation in serum concentration calculated as ((Cmax-Cmin)/Cavg) x 100%.
Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Area Under the Time Concentration Curve [AUC(0-24h)]
Time frame: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
Area under the serum concentration versus time curve was calculated using the linear trapezoidal rule from time 0 to 24 hours on Day 7.

1 secondary outcome

Number of Participants With Adverse Events
Time frame: Baseline through 7 days of each cycle of four treatments and follow-up (up to 38 days)

Results and safety

Results posted to the registry on 7 Jan 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Testosterone MD-Lotion	21	21

Primary outcome: Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax)

Time frame: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment. Median (Full Range). Unit: hours (h)

Measure	3 mL (30 mg) of 1% Testosterone MD-Lotion n = 21	1.5 mL (30 mg) of 2% Testosterone MD-Lotion n = 21	3 mL (60 mg) of 2% Testosterone MD-Lotion n = 21	4.5 mL (90 mg) of 2% Testosterone MD-Lotion n = 21
Total Testosterone	8.00 (1.93 to 24.00)	12.00 (1.95 to 23.93)	4.25 (0.00 to 20.00)	15.98 (1.92 to 23.97)
Dihydrotestosterone	8.00 (1.93 to 24.00)	11.93 (0.00 to 23.93)	4.25 (0.00 to 24.00)	15.98 (0.00 to 24.00)
Free Testosterone	8.00 (1.93 to 24.00)	12.00 (1.95 to 23.93)	4.25 (0.00 to 20.00)	15.98 (1.92 to 23.97)

Population analysed: All participants received all four doses of testosterone MD-lotion.

Primary outcome: Pharmacokinetics of Total Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)

Time frame: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment. Mean (Standard Deviation). Unit: ng/dL

Measure	3 mL (30 mg) of 1% Testosterone MD-Lotion n = 21	1.5 mL (30 mg) of 2% Testosterone MD-Lotion n = 21	3 mL (60 mg) of 2% Testosterone MD-Lotion n = 21	4.5 mL (90 mg) of 2% Testosterone MD-Lotion n = 21
Cmax	546 (266)	430 (259)	590 (289)	626 (264)
Cmin	164 (63)	171 (59)	221 (101)	238 (135)
Cavg (n=21, n=20, n=21, n=21)	338 (100)	294 (150)	389 (152)	432 (185)

Population analysed: All participants received all four doses of testosterone-MD lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.

Primary outcome: Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)

Time frame: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment. Mean (Standard Deviation). Unit: ng/dL

Measure	3 mL (30 mg) of 1% Testosterone MD-Lotion n = 21	1.5 mL (30 mg) of 2% Testosterone MD-Lotion n = 21	3 mL (60 mg) of 2% Testosterone MD-Lotion n = 21	4.5 mL (90 mg) of 2% Testosterone MD-Lotion n = 21
Cmax	90.7 (64.1)	69.4 (58.6)	96.4 (46.2)	98.6 (46.1)
Cmin	33.3 (14.4)	34.6 (26.5)	47.8 (29.4)	49.4 (26.7)
Cavg (n=21, n=20, n=21, n=21)	62.3 (34.0)	53.0 (45.4)	71.4 (35.1)	76.5 (35.9)

Primary outcome: Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)

Time frame: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment. Mean (Standard Deviation). Unit: ng/dL

Measure	3 mL (30 mg) of 1% Testosterone MD-Lotion n = 21	1.5 mL (30 mg) of 2% Testosterone MD-Lotion n = 21	3 mL (60 mg) of 2% Testosterone MD-Lotion n = 21	4.5 mL (90 mg) of 2% Testosterone MD-Lotion n = 21
Cmax	14.6 (7.5)	11.3 (5.9)	15.9 (7.8)	16.5 (6.2)
Cmin	4.4 (1.7)	4.5 (1.3)	5.9 (2.7)	6.4 (3.6)
Cavg n=21, n=20, n=21, n=21)	8.9 (2.6)	7.6 (3.1)	10.4 (3.9)	11.4 (4.6)

Population analysed: All participants received all four doses of testosterone MD-lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
3 mL (30 mg) of 1% Testosterone MD-Lotion	0 of 21 (0%)	4 of 21 (19%)	Not reported
1.5 mL (30 mg) of 2% Testosterone MD-Lotion	0 of 21 (0%)	5 of 21 (23.8%)	Not reported
3 mL (60 mg) of 2% Testosterone MD-Lotion	0 of 21 (0%)	6 of 21 (28.6%)	Not reported
4.5 mL (90 mg) of 2% Testosterone MD-Lotion	0 of 21 (0%)	5 of 21 (23.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypogonadism

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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 1-31- Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Testosterone MD-Lotion in people with Hypogonadism, run by Eli Lilly and Company at 4 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 7 inclusion and 22 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 7 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 7 Jan 2011). 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?

Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax) (time frame: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment). The study lists 6 primary outcomes in all. 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 NCT00857961.

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 7 Jan 2011.