Male HypogonadismPhase 3NCT01765179
Safety and Efficacy Trial of Testosterone Undecanoate
A Phase 3 study testing Oral testosterone undecanoate in people with Male Hypogonadism, run by Clarus Therapeutics, Inc. at 27 sites in United States.
Trial summary
The purpose of the study is to determine if oral testosterone undecanoate is effective and safe in the treatment of low testosterone in men. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Male Hypogonadism
- What is being tested?
- Oral testosterone undecanoate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 27 sitesUnited States
- Study dates
- Jan 2013to Jul 2013
- 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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Serum testosterone of less than or equal to 300 ng/dL (the mean of two samples collected 1 hour apart in the morning between 6:00 and 10:00 AM)
Who cannot join
- Significant intercurrent disease of any type, in particular liver, kidney, uncontrolled or poorly controlled heart disease including hypertension, CHF or CAD, or psychiatric illness including depression.
- Recent history of stroke, including transient ischemic attack (TIA) or acute coronary event
- Untreated, severe obstructive sleep apnea
- Hematocrit <35% or >48%
- Serum transaminases >2 times upper limit of normal, serum bilirubin >2.0 mg/dL, and serum creatinine >2.0 mg/dL
- BMI > or equal to 38
Show all 16Show fewer
- Stable doses of lipid-lowering medication for less than three months
- Stable doses of oral medication for diabetes for less than two months
- Abnormal prostate digital rectal examination [palpable nodule(s)], elevated PSA (serum PSA >3.9 ng/mL), IPSS score > or equal to 19 points, and /or history of prostate cancer.
- History of breast cancer
- Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary supplements that may increase serum T, such as androstenedione or DHEA with the previous 4 weeks
- Know malabsorption syndrome and/or current treatment iwht oral lipase inhibitors
- Known history of abuse of alcohol or any drug substance with the previous 2 years
- Current use of antiandrogens, estrogens, oral CYP3A4 inducers or inhibitors, or long-acting opioid analgesics
- Receipt of any drug as part of a research study within 30 days of initial dose administration in this study
- Blood donation within the 12 week period before initial dose administration in this study
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
South Florida Medical Research
Aventura, Florida, 33180
Unrologic Consultants of SE Pennsylvania
Bala-Cynwyd, Pennsylvania, 19004
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235
Alabama Internal Medicine, PC
Birmingham, Alabama, 35235
PAB Clinical Research
Brandon, Florida, 33511
Research Across America
Carrollton, Texas, 75010
Innovative Research of West Florida
Clearwater, Florida, 33756
Research Across America
Dallas, Texas, 75234
SC Clinical Research, Inc.
Garden Grove, California, 92844
Precision Trials/Valley Urologic Associates
Glendale, Arizona, 85308
Clinical Trial Network
Houston, Texas, 77074
Medical Affliated Research Center, Inc.
Huntsville, Alabama, 35801
Potenium Clinical Research, LLC
Hurst, Texas, 76053
Jacksonville Impotence Treatment Center
Jacksonville, Florida, 32223
South ORange County Endocrinology
Laguna Hill, California, 92653
Tower Urology, Tower Research Institute
Los Angeles, California, 90048
Sunstone Medical Research
Medford, Oregon, 97504
Conneticut Clinical Research Center
Middlebury, Connecticut, 06762
University Urology Associates
New York, New York, 10016
Premier Clinical Research Center
Phoenix, Arizona, 85027
Precision Trials/Valley Urologic Associates
Phoenix, Arizona, 85032
Rainer Clinical Research Center, Inc.
Renton, Washington, 98057
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
San Diego Sexual Medicine
San Diego, California, 92120
University of Washington
Seattle, Washington, 98195
LABiomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, 90502
Quality of LIfe Medical and Research Center
Tucson, Arizona, 85712
About this study
Official title: Phase III, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU)in Hypogonadal Men
The purpose of the study is to determine if oral testosterone undecanoate is effective and safe in the treatment of low testosterone in men.
- Conditions
- Male Hypogonadism
- Being tested
- Oral testosterone undecanoate
- Keywords
- testosterone, male hypogonadism, low testosterone
- Medical subject headings
- Eunuchism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral testosterone undecanoateDrug
Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.
| Study group | Role | What they receive |
|---|---|---|
| Oral testosterone undecanoate | Experimental | Not described Receives: Drug: Oral testosterone undecanoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Treated Patients With an Average Serum Testosterone (T) Concentration (Cavg) Between 300 and 1000 ng/dL
The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114.
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114
Secondary outcomes (1)
Percentage of Treated Patients With Maximum Serum T Concentrations (Cmax) Values in Selected Ranges on Day 114 Efficacy Population
The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114.
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2013
- Study completionJul 2013
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 Male HypogonadismStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clarus Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- inVentiv Health Clinical
- Responsible party
- Sponsor
- Investigators
- Ronald Swerdloff, MD, Principal investigator, Los Andgeles Biomedical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765179
- Sponsor's protocol ID
- CLAR-12011
- Status last verified
- Nov 2017
- First submitted
- 8 Jan 2013
- Last updated
- 12 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU)in Hypogonadal Men
- ClinicalTrials.gov ID
- NCT01765179
- Acronym / sponsor ID
- CLAR-12011
- Conditions
- Male Hypogonadism
- Keywords
- testosterone, male hypogonadism, low testosterone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Clarus Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- inVentiv Health Clinical
- Study start
- Jan 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 10 Jan 2013 (estimated)
- Results
- Posted 21 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine if oral testosterone undecanoate is effective and safe in the treatment of low testosterone in men.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral testosterone undecanoate | Experimental | Drug: Oral testosterone undecanoate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Serum testosterone of less than or equal to 300 ng/dL (the mean of two samples collected 1 hour apart in the morning between 6:00 and 10:00 AM)
Key exclusion criteria (16 listed)
- Significant intercurrent disease of any type, in particular liver, kidney, uncontrolled or poorly controlled heart disease including hypertension, CHF or CAD, or psychiatric illness including depression.
- Recent history of stroke, including transient ischemic attack (TIA) or acute coronary event
- Untreated, severe obstructive sleep apnea
- Hematocrit <35% or >48%
- Serum transaminases >2 times upper limit of normal, serum bilirubin >2.0 mg/dL, and serum creatinine >2.0 mg/dL
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 |
|---|---|---|
| Oral testosterone undecanoateInitial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments. | Drug | Oral testosterone undecanoate |
Primary outcome
Percentage of Treated Patients With an Average Serum Testosterone (T) Concentration (Cavg) Between 300 and 1000 ng/dL
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114
The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114.
1 secondary outcome
Percentage of Treated Patients With Maximum Serum T Concentrations (Cmax) Values in Selected Ranges on Day 114 Efficacy Population
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ronald Swerdloff, MD principal investigator
Los Andgeles Biomedical Research Institute
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oral testosterone undecanoate in people with Male Hypogonadism, run by Clarus Therapeutics, Inc. at 27 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 1 inclusion and 16 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 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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 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 21 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Treated Patients With an Average Serum Testosterone (T) Concentration (Cavg) Between 300 and 1000 ng/dL (time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2017.