HypogonadismPhase 1/2NCT02670343
Phlebotomy Study of Testosterone Undecanoate
A Phase 1/2 study testing Oral Testosterone Undecanoate in people with Hypogonadism, run by Clarus Therapeutics, Inc. at 1 site in United States.
Trial summary
An open-label, single oral TU dose study was conducted in eight (8) hypogonadal men at a single study site. Each study participant received a single oral TU dose immediately prior to a standardized breakfast meal comprised of 800 to 1000 calories and approximately 30 g of fat. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- 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
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Mar 2016
- Phase
- Phase 1/2
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, 18 to 65 years of age, inclusive, with a diagnosis of hypogonadism and a screening total serum T of < 300 ng/dL.
- Adequate venous access to allow blood sample collections via venous cannula.
- Naïve to androgen-replacement therapy or willing to temporarily cease current T treatment and willing to remain off all forms of T except for study medication throughout study.
- Voluntarily provide written informed consent to participate in this study.
Who cannot join
- Subjects meeting any of the following exclusion criteria will not be eligible:
- Significant intercurrent disease (especially liver, kidney, heart disease, uncontrolled diabetes mellitus or psychiatric illness)
- Abnormal prostate digital rectal examination, elevated PSA (PSA > 4 ng/mL), AUA Symptom Score ≥ 15 points and/or history of prostate CA.
- BMI less than 18 kg/m2 or greater than 37 kg/m2
- Serum transaminases > 2 times upper limit of normal (ULN) or serum bilirubin >2.0 mg/dL.
- History of severe or multiple allergies, or severe adverse drug reaction. A known hypersensitivity to lidocaine or all surgical dressings which may be used in the study procedures.
Show all 19Show fewer
- History of abnormal bleeding tendencies or thrombophlebitis unrelated to venipuncture or intravenous cannulation.
- Oral, topical or buccal T therapy within previous one week, or intramuscular T injection within previous 4 weeks.
- Parenteral T-undecanoate therapy within the past 6 months.
- Use of dietary supplements that may increase serum T, within previous 4 weeks.
- Known malabsorption syndrome and/or current treatment with oral lipase inhibitors, bile acid-binding resins, colestipol, fibric acid derivatives, clofibrate, gemfibrozil, and probucol.
- Smokers unable to refrain from smoking during required confinement period.
- History of, or current evidence of, abuse of alcohol or any drug substance.
- Receipt of any research study drug within 30 days of study.
- Blood donation within the 12 week period before the initial study dose.
- Hematocrit less than 35% or greater than 50%.
- History of clinically significant polycythemia following treatment with a testosterone replacement product.
- Current use of paroxetine, clomipramine, antiandrogens, estrogens, potent P450 enzyme inducers, or barbiturates.
- History of uncontrolled sleep apnea.
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles Biomedical Research Institute
Torrance, California, 90502
About this study
Official title: Evaluation of Blood Collection Methodology Following Administration of a Single-Dose of an Oral Testosterone Undecanoate Formulation In Hypogonadal Men
An open-label, single oral TU dose study was conducted in eight (8) hypogonadal men at a single study site. Each study participant received a single oral TU dose immediately prior to a standardized breakfast meal comprised of 800 to 1000 calories and approximately 30 g of fat. Blood samples were collected 30 minutes prior dose administration and at 0 pre-dose and post dose at the following hours post-dose; 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours.
Read the detailed description
This open-label, single oral dose, phlebotomy study was designed to clarify the issue of the influence of blood collection tubes on T, DHT, TU and DHTU measurements by collecting blood samples into various collection tubes from a small number of hypogonadal men dosed with a single oral TU dose in the form of a SEDDS formulation.
- Conditions
- Hypogonadism
- Being tested
- Oral Testosterone Undecanoate
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Testosterone UndecanoateDrug
Also called testosterone undecanoate
Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone.
| Study group | Role | What they receive |
|---|---|---|
| Oral Testosterone Undecanoate | Experimental | A single dose of oral testosterone undecanoate equivalent to 200 mg of testosterone in the form of two soft gelatin capsules containing 158 mg of testosterone undecanoate will be administered to each subject. Receives: Drug: Oral Testosterone Undecanoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of Mean Difference in T Concentration Compared to Plain Collection Tube
The measured outcome presented is the difference as a percent of mean of T results when comparing T Concentrations measured in three different types of NaF containing collection tubes (NaF+EDTA, NaF+Oxalate and NaF) to T measured in blood collected in plain tubes. The % of Mean Difference in T concentration for each tube type was obtained by taking the average at each time point a T concentration was obtained, and calculating the mean difference between the test ((NaF+EDTA, NaF+Oxalate and NaF) tubes and the control (plain) tube.
The concentration of total T will be determined in the serum/plasma samples of all subjects using validated LC/MS/MS methods at the Endocrine and Metabolic Research Lab.
Measured: Sample collection at -0.5, and 0 hours pre-dose and post-dose samples collected at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12, hours after a single dose of oral TU.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionMar 2016
- Study completionMar 2016
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.
- 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 1/2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clarus Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christina Wang, M.D., Principal investigator, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670343
- Sponsor's protocol ID
- CLAR-15013
- Status last verified
- Feb 2018
- First submitted
- 28 Jan 2016
- Last updated
- 9 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Individual participant data will be provided to each respective investigator at the end of the trial.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Blood Collection Methodology Following Administration of a Single-Dose of an Oral Testosterone Undecanoate Formulation In Hypogonadal Men
- ClinicalTrials.gov ID
- NCT02670343
- Acronym / sponsor ID
- CLAR-15013
- Conditions
- Hypogonadism
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Clarus Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 1 Feb 2016 (estimated)
- Results
- Posted 9 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label, single oral TU dose study was conducted in eight (8) hypogonadal men at a single study site. Each study participant received a single oral TU dose immediately prior to a standardized breakfast meal comprised of 800 to 1000 calories and approximately 30 g of fat. Blood samples were collected 30 minutes prior dose administration and at 0 pre-dose and post dose at the following hours post-dose; 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours.
Detailed description
This open-label, single oral dose, phlebotomy study was designed to clarify the issue of the influence of blood collection tubes on T, DHT, TU and DHTU measurements by collecting blood samples into various collection tubes from a small number of hypogonadal men dosed with a single oral TU dose in the form of a SEDDS formulation.
Study design
- Primary purpose
- Basic science
- 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 UndecanoateA single dose of oral testosterone undecanoate equivalent to 200 mg of testosterone in the form of two soft gelatin capsules containing 158 mg of testosterone undecanoate will be administered to each subject. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male, 18 to 65 years of age, inclusive, with a diagnosis of hypogonadism and a screening total serum T of < 300 ng/dL.
- Adequate venous access to allow blood sample collections via venous cannula.
- Naïve to androgen-replacement therapy or willing to temporarily cease current T treatment and willing to remain off all forms of T except for study medication throughout study.
- Voluntarily provide written informed consent to participate in this study.
Key exclusion criteria (19 listed)
- Significant intercurrent disease (especially liver, kidney, heart disease, uncontrolled diabetes mellitus or psychiatric illness)
- Abnormal prostate digital rectal examination, elevated PSA (PSA > 4 ng/mL), AUA Symptom Score ≥ 15 points and/or history of prostate CA.
- BMI less than 18 kg/m2 or greater than 37 kg/m2
- Serum transaminases > 2 times upper limit of normal (ULN) or serum bilirubin >2.0 mg/dL.
- History of severe or multiple allergies, or severe adverse drug reaction. A known hypersensitivity to lidocaine or all surgical dressings which may be used in the study procedures.
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: testosterone undecanoateSubjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone. | Drug | Oral Testosterone Undecanoate |
Primary outcome
% of Mean Difference in T Concentration Compared to Plain Collection Tube
Time frame: Sample collection at -0.5, and 0 hours pre-dose and post-dose samples collected at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12, hours after a single dose of oral TU.
The measured outcome presented is the difference as a percent of mean of T results when comparing T Concentrations measured in three different types of NaF containing collection tubes (NaF+EDTA, NaF+Oxalate and NaF) to T measured in blood collected in plain tubes. The % of Mean Difference in T concentration for each tube type was obtained by taking the average at each time point a T concentration was obtained, and calculating the mean difference between the test ((NaF+EDTA, NaF+Oxalate and NaF) tubes and the control (plain) tube. The concentration of total T will be determined in the serum/plasma samples of all subjects using validated LC/MS/MS methods at the Endocrine and Metabolic Research Lab.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Individual participant data will be provided to each respective investigator at the end of the trial.
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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.
Christina Wang, M.D. principal investigator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Oral Testosterone Undecanoate in people with Hypogonadism, run by Clarus Therapeutics, Inc. at 1 site 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 4 inclusion and 19 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 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 9 Mar 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?
% of Mean Difference in T Concentration Compared to Plain Collection Tube (time frame: Sample collection at -0.5, and 0 hours pre-dose and post-dose samples collected at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12, hours after a single dose of oral TU.). 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 9 Mar 2018.