Male HypogonadismPhase 3NCT01403116
Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
A Phase 3 study testing Oral testosterone undecanoate and topical testosterone gel in people with Male Hypogonadism, run by Clarus Therapeutics, Inc. at 30 sites in 2 countries.
Trial summary
The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone. 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 and topical testosterone gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 30 sitesin 2 countries
- Study dates
- Jul 2011to Sep 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 on two occasions within one week (may wash out from previous oral, topical or buccal testosterone therapy)
Who cannot join
- Significant intercurrent disease of any type, in particular liver, kidney, uncontrolled or poorly controlled heart disease, or psychiatric illness
- Recent history of stroke, not including transient ischemic attack
- Untreated, sever 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 mgk/dL
- BMI > or equal to 36
Show all 16Show fewer
- Stable doses of lipid-lowering medication for less than 3 months
- Stable doses of oral medication for diabetes for less than 2 months
- Abnormal prostate DRE [palpable nodule(s)], elevated PSA (>4 ng/mL), IPSS score > or equal to 19 points.
- History of breast cancer
- Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary supplements that may increase serum testosterone within previous 4 weeks
- Known malabsorption syndrome and/or current treatment with oral lipase inhibitors
- History of abuse of alcohol or any drug substance within 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 the initial study dose.
Trial locations and contacts
30 sites in 2 countries.
30 sites in 2 countries
United States25 sites
South Florida Medical Research
Aventura, Florida, 33180
Urologic Consultants of Southeast Pennsylvania
Bala-Cynwyd, Pennsylvania, 19004
Johns Hopkins University
Baltimore, Maryland, 21287
Alabama Clinical Therapeutics, Inc.
Birmingham, Alabama, 35235
Alabama Internal Medicine, PC
Birmingham, Alabama, 35235
Boston University School of Medicine
Boston, Massachusetts, 02118
Maimonides Medical Center
Brooklyn, New York, 11235
Providence Clinical Research
Burbank, California, 91505
Alabama Clinical Therapeutics
Calera, Alabama, 35040
Research Across America
Carrollton, Texas, 75010
Research Across America
Dallas, Texas, 75234
Bruce R. Gilbert, MD, PhD
Great Neck, New York, 11021
Medical Affliated Research Center, Inc.
Huntsville, Alabama, 35801
South Orange County Endocrinology
Laguna Hills, California, 92653
Tower Urology
Los Angeles, California, 90048
David Geffen School of Medicine
Los Angeles, California, 90095
University of Louisville
Louisville, Kentucky, 40202
Sunstone Medical Research
Medford, Oregon, 97504
Connecticut Clinical Research Center/ConnecTrials
Middlebury, Connecticut, 06762
University of CT School of Medicine
New Haven, Connecticut, 06511
University Urology Associates
New York, New York, 10016
Michael A. Werner, MD, PC
Purchase, New York, 10577
University of Washington
Seattle, Washington, 98195
Harbor-UCLA Medical Center, LA Biomedical Research Institute
Torrance, California, 90502
Quality of Life Medical and Research Centers, LLC
Tucson, Arizona, 85712
Germany5 sites
University of Bonn, Clinic for Dermatology and Allergy
Bonn
University of Halle, Center for Reproduction and Androlgoy
Halle
Praxis Dr. Szymula
Leipzig
Praxis Dr. Schulze
Markkleeberg
University of Muenster, Center for Reproduction and Andrology
Münster
About this study
Official title: Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.
Read the detailed description
This was a randomized, open-label, 2-arm, active controlled, 12-month study of Oral TU that planned to enroll ≈ 300 hypogonadal men (≈ 150/group) at multiple study sites. Incorporated in the design was dose titration based on serum T concentration assessed 4-6 hrs post AM dose. Following a 2-visit screening period during which a serum T concentration was measured, eligible subjects were randomized to either Oral TU (Group A) or transdermal T-gel (Group B) for dosing during Treatment Period 1 (Days 0 to 42). Group A was initially dosed with 400 mg T daily (two 100 mg capsules, orally, twice a day [BID]), and Group B was initially dosed with 5 g of transdermal 1% T-gel.
Serum T sampling was done on Day 30, 4-6 hours after the morning dose and these T concentration results were used to determine the need for dose titration. Dose titration occurred on Day 42 for Treatment Period 2, until Day 90. Subjects whose dose was titrated on Day 42 were re-evaluated on Day 60 , with dose adjustments made as necessary on Day 74.
Serum T sampling was performed on Day 90, for Oral TU subjects who had dose titration on Day 74, on Day 105. If the serum T level was > 1800 ng/dL, the sample was repeated; subjects were discontinued if the second assayed T concentration was > 1800 ng/dL. An additional dose titration was done for subjects whose Day 180 occurred after a protocol amendment. Subjects taking 150 mg T BID with serum T over 1500 ng/dL on two separate draws were discontinued.
Safety measures included physical examination, vital signs, fasting laboratory analysis (hematology, chemistry, urinalysis), CV biomarker monitoring [hs-CRP, Lp-PLA2, Lp(a), and ApoA1], measurement of sex hormone binding globulin (SHBG); luteinizing hormone (LH), follicle-stimulating hormone (FSH); prostate specific antigen (PSA), and the American Urological Association/International Prostate Symptom Score (AUA/I-PSS).
- Conditions
- Male Hypogonadism
- Being tested
- Oral testosterone undecanoate, topical testosterone gel
- 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
Also called Oral TU
Starting dose: 200 mg T (as TU) BID. Doses may be titrated up to a maximum dose of 300 mg T (as TU) BID or down to a minimum dose of 100 mg T (as TU) BID based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.
topical testosterone gelDrug
Also called T-gel
Starting dose: 5 g T applied once daily. Doses may be titrated up to a maximum dose of 10 g daily or down to a minimum dose of 2.5 g daily based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.
| Study group | Role | What they receive |
|---|---|---|
| Oral testosterone undecanoate (TU) | Experimental | Treatment Period 1: 100 mg capsules, BID, with food
Treatment Period 2: One of the following dosages:
* 100 mg BID
* 150 mg BID
* 100 mg BID
* 100 mg and 150 mg BID
* 150 mg capsules BID
Safety Follow-up Phase:
Initial dose: ~84 doses Maintenance dose-Titrated dose: ~96 doses Safety follow-up at maintenance dose: ~540 doses Receives: Drug: Oral testosterone undecanoate |
| topical testosterone gel | Active comparator | Treatment Period 1: 5 g of 1% transdermal T-gel applied QD
Treatment Period 2:
* 2.5 g of 1% transdermal T-gel applied QD
* 5 g of 1% transdermal T-gel applied QD
* 7.5 g of 1% transdermal T-gel applied QD
* 10 g of 1% transdermal T-gel applied QD
Safety Follow-up Phase:
Initial dose: ~42 doses Maintenance dose-Titrated dose: ~48 doses Safety follow-up at maintenance dose: ~270 doses Receives: Drug: topical testosterone gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Treated Patients With Average Serum Testosterone (T) Concentrations (Cavg) Between 300 and 1000 ng/dL
The percentages of treated subjects that had 24-hour serum testosterone (T) average concentrations (Cavg) between 300 and 1000 ng/dL
Measured: Following 90 days of treatment
Secondary outcomes (1)
% of Oral TU Subjects With 24-hour Maximum Serum T Concentrations (Cmax) Greater Than 1500 ng/dL on Day 90
Percentage of Oral TU treated patients who reached study day 90 and had a maximum serum T concentrations (Cmax) values greater than 1500 ng/dL(objective to meet <15%).
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionSep 2013
- Study completionSep 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clarus Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PharmaNet, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Responsible party
- Sponsor
- Investigators
- Ronald Swerdloff, MD, Principal investigator, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403116
- Sponsor's protocol ID
- CLAR-09007
- Status last verified
- Jul 2018
- First submitted
- 25 Jul 2011
- Last updated
- 14 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to share IPD
Publications
Honig S, Gittelman M, Kaminetsky J, Wang C, Amory JK, Rohowsky N, Dudley RE, Woun Seo B, Newmark J, Swerdloff R. Two-Year Analysis of a New Oral Testosterone Undecanoate (TU) Formulation in Hypogonadal Men: Efficacy, Impact on Psychosexual Function, and Safety. J Sex Med. 2022 Dec;19(12):1750-1758. doi: 10.1016/j.jsxm.2022.09.002. Epub 2022 Oct 20.
PubMed 36272969
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
- ClinicalTrials.gov ID
- NCT01403116
- Acronym / sponsor ID
- CLAR-09007
- Conditions
- Male Hypogonadism
- Keywords
- testosterone, male hypogonadism, low testosterone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Clarus Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- PharmaNet, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Study start
- Jul 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 27 Jul 2011 (estimated)
- Results
- Posted 14 Aug 2018
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 this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.
Detailed description
This was a randomized, open-label, 2-arm, active controlled, 12-month study of Oral TU that planned to enroll ≈ 300 hypogonadal men (≈ 150/group) at multiple study sites. Incorporated in the design was dose titration based on serum T concentration assessed 4-6 hrs post AM dose. Following a 2-visit screening period during which a serum T concentration was measured, eligible subjects were randomized to either Oral TU (Group A) or transdermal T-gel (Group B) for dosing during Treatment Period 1 (Days 0 to 42). Group A was initially dosed with 400 mg T daily (two 100 mg capsules, orally, twice a day [BID]), and Group B was initially dosed with 5 g of transdermal 1% T-gel.
Serum T sampling was done on Day 30, 4-6 hours after the morning dose and these T concentration results were used to determine the need for dose titration. Dose titration occurred on Day 42 for Treatment Period 2, until Day 90. Subjects whose dose was titrated on Day 42 were re-evaluated on Day 60 , with dose adjustments made as necessary on Day 74.
Serum T sampling was performed on Day 90, for Oral TU subjects who had dose titration on Day 74, on Day 105. If the serum T level was > 1800 ng/dL, the sample was repeated; subjects were discontinued if the second assayed T concentration was > 1800 ng/dL. An additional dose titration was done for subjects whose Day 180 occurred after a protocol amendment. Subjects taking 150 mg T BID with serum T over 1500 ng/dL on two separate draws were discontinued.
Safety measures included physical examination, vital signs, fasting laboratory analysis (hematology, chemistry, urinalysis), CV biomarker monitoring [hs-CRP, Lp-PLA2, Lp(a), and ApoA1], measurement of sex hormone binding globulin (SHBG); luteinizing hormone (LH), follicle-stimulating hormone (FSH); prostate specific antigen (PSA), and the American Urological Association/International Prostate Symptom Score (AUA/I-PSS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral testosterone undecanoate (TU) | Experimental | Drug: Oral testosterone undecanoateTreatment Period 1: 100 mg capsules, BID, with food Treatment Period 2: One of the following dosages: * 100 mg BID * 150 mg BID * 100 mg BID * 100 mg and 150 mg BID * 150 mg capsules BID Safety Follow-up Phase: Initial dose: ~84 doses Maintenance dose-Titrated dose: ~96 doses Safety follow-up at maintenance dose: ~540 doses |
| topical testosterone gel | Active comparator | Drug: topical testosterone gelTreatment Period 1: 5 g of 1% transdermal T-gel applied QD Treatment Period 2: * 2.5 g of 1% transdermal T-gel applied QD * 5 g of 1% transdermal T-gel applied QD * 7.5 g of 1% transdermal T-gel applied QD * 10 g of 1% transdermal T-gel applied QD Safety Follow-up Phase: Initial dose: ~42 doses Maintenance dose-Titrated dose: ~48 doses Safety follow-up at maintenance dose: ~270 doses |
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 on two occasions within one week (may wash out from previous oral, topical or buccal testosterone therapy)
Key exclusion criteria (16 listed)
- Significant intercurrent disease of any type, in particular liver, kidney, uncontrolled or poorly controlled heart disease, or psychiatric illness
- Recent history of stroke, not including transient ischemic attack
- Untreated, sever 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 mgk/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 undecanoateAlso: Oral TUStarting dose: 200 mg T (as TU) BID. Doses may be titrated up to a maximum dose of 300 mg T (as TU) BID or down to a minimum dose of 100 mg T (as TU) BID based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60. | Drug | Oral testosterone undecanoate (TU) |
| topical testosterone gelAlso: T-gelStarting dose: 5 g T applied once daily. Doses may be titrated up to a maximum dose of 10 g daily or down to a minimum dose of 2.5 g daily based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60. | Drug | topical testosterone gel |
Primary outcome
Percentage of Treated Patients With Average Serum Testosterone (T) Concentrations (Cavg) Between 300 and 1000 ng/dL
Time frame: Following 90 days of treatment
The percentages of treated subjects that had 24-hour serum testosterone (T) average concentrations (Cavg) between 300 and 1000 ng/dL
1 secondary outcome
% of Oral TU Subjects With 24-hour Maximum Serum T Concentrations (Cmax) Greater Than 1500 ng/dL on Day 90
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36272969Honig S, Gittelman M, Kaminetsky J, Wang C, Amory JK, Rohowsky N, Dudley RE, Woun Seo B, Newmark J, Swerdloff R. Two-Year Analysis of a New Oral Testosterone Undecanoate (TU) Formulation in Hypogonadal Men: Efficacy, Impact on Psychosexual Function, and Safety. J Sex Med. 2022 Dec;19(12):1750-1758. doi: 10.1016/j.jsxm.2022.09.002. Epub 2022 Oct 20.
- Individual participant dataSharing planned: No. No plan to share IPD
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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
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
30 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oral testosterone undecanoate and topical testosterone gel in people with Male Hypogonadism, run by Clarus Therapeutics, Inc. at 30 sites in 2 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 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 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Germany. 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 14 Aug 2018). 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 Average Serum Testosterone (T) Concentrations (Cavg) Between 300 and 1000 ng/dL (time frame: Following 90 days of treatment). 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 NCT01403116, which also lists 1 linked publication.
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 14 Aug 2018.