Hypogonadism, MalePhase 1NCT03973840
Assessment of Blood From Men Receiving Oral TU in Various Collection Tubes
A Phase 1 study testing Testosterone Undecanoate in people with Hypogonadism, Male, run by Clarus Therapeutics, Inc. at 1 site in United States.
Trial summary
To describe the rate of post-collection TU to testosterone conversion, as manifested by increases in testosterone concentration, in Plain tubes held at room temperature and sodium fluoride (NaF)-ethylenediaminetetraacetic acid (EDTA) tubes held at room temperature or on ice prior to centrifugation Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypogonadism, Male
- What is being tested?
- Testosterone Undecanoate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2018to 31 Jul 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects were required to meet all of the following criteria in order to be eligible for the study:
- Male (gender at birth) 18 to 65 years of age, inclusive, and legally able to give informed consent, as applicable by law. The percentage of non-Hispanic and Hispanic men was specified to be approximately ≥ 70% and ≤ 30%, respectively.
- Adequate venous access in the left or right arm to allow collection of a number of blood samples via a venous cannula or needle sticks
- Naïve to androgen-replacement therapy
- Willing to consume the entire protocol-specified breakfast and dinner meals
- Average screening systolic blood pressure < 140 mmHg and/or diastolic blood pressure < 90 mmHg
- Voluntarily gave written informed consent to participate in this study -
Who cannot join
- Subjects who met any of the following criteria were not eligible for participation in this study:
- History of hypertension or taking anti-hypertensive medications
- Intercurrent disease deemed clinically significant, in the opinion of the Investigator, of any type; in particular, liver, kidney, uncontrolled or poorly controlled heart disease, including congestive heart failure, coronary heart disease, heart attack or cerebrovascular accident in prior 6 months, or psychiatric-illness, including severe depression
- Electrocardiogram which Principal Investigator, or designate, believed was clinically significantly abnormal
- Intercurrent process or disease which could have impacted the absorption of JATENZO, in particular vomiting, nausea, diarrhea, or inflammatory bowel disease
- Current use of the following groups of drugs that affect testosterone levels, testosterone metabolism, or levels of testosterone metabolites, namely antiandrogens, 5 alpha reductase inhibitors (eg, dutasteride, finasteride), estrogens, long-acting opioid analgesics (eg, methadone hydrochloride, buprenorphine hydrochloride), or human growth hormone
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- History of or was currently being evaluated for breast or prostate cancer
- Prostate specific antigen above the upper limit of normal
- Positive test for antibodies to human immunodeficiency virus type 1 or 2, hepatitis B surface antigen, or antibodies to hepatitis C virus at the Screening visit
- Positive urine drug test at the Screening visit
- Current treatment with oral lipase inhibitors (eg, orlistat [Xenical]), bile acid-binding resins (eg, cholestyramine [Questran], colestipol [Colestid]), fibric acid derivatives (eg, clofibrate [Atromid-X], gemfibrozil [Lopid]), and probucol (Lorelco).
- Smokers who were unable to refrain from smoking during the confinement period required in this study
- Current evidence of or history of abuse of alcohol or any drug substance within the previous 2 years
- Receipt of any drug as part of a research study within 30 days of initial dose administration in this study
- Blood donation (usually 550 mL) within the 12-week period before the initial study drug dose
- Hematocrit < 35% or > 50%
- Body mass index ≥ 31 kg/m2 -
Trial locations and contacts
1 site in 1 country.
United States1 site
Clarus Therapeutics, Inc
Northbrook, Illinois, 60062
About this study
Official title: A Study to Assess Post-collection Conversion of Testosterone Undecanoate (TU) to Testosterone in Blood From Men Receiving Oral TU Collected Into Different Types of Sample Tubes
To describe the rate of post-collection TU to testosterone conversion, as manifested by increases in testosterone concentration, in Plain tubes held at room temperature and sodium fluoride (NaF)-ethylenediaminetetraacetic acid (EDTA) tubes held at room temperature or on ice prior to centrifugation
Read the detailed description
This was an open-label, non-randomized, single-sequence study in which men dosed with JATENZO had blood drawn into 3 different types of blood-collection tubes (ie, Plain, EDTA, and NaF-EDTA). These tubes were then processed in different ways (ie, different durations between phlebotomy and centrifugation, different holding temperatures [room temperature or on ice] between phlebotomy and centrifugation). After defined periods of incubation, the tubes were centrifuged and the serum/plasma transferred into vials and frozen. The testosterone and TU levels in the serum/plasma were then measured using validated liquid chromatography/tandem mass spectrometry assays.
- Conditions
- Hypogonadism, Male
- Being tested
- Testosterone Undecanoate
- Medical subject headings
- Eunuchism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone UndecanoateDrug
dose was given orally and allowed to reach steady state
| Study group | Role | What they receive |
|---|---|---|
| healthy men treatment arm | Experimental | Subjects were given 15 doses over 8 days, and then blood was drawn into several types of collection tubes at different storage conditions. Receives: Drug: Testosterone Undecanoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure rate of post-collection TU-to-testosterone conversion in 3 types of collection tubes
To describe the rate of post-collection TU to testosterone conversion, as manifested by increases in testosterone concentration, in Plain tubes held at room temperature and sodium fluoride (NaF)-ethylenediaminetetraacetic acid (EDTA) tubes held at room temperature or on ice prior to centrifugation
Measured: 8 days
Secondary outcomes (3)
rate of post-collection TU-to-testosterone conversion, as manifested by increases in testosterone concentration, in EDTA and NaF-EDTA collection tubes
To describe the rate of post-collection TU to testosterone conversion, as manifested by increases in testosterone concentration, in EDTA and NaF-EDTA tubes held at room temperature or on ice prior to centrifugation
Measured: 8 days
magnitude of overestimation of the true circulating testosterone concentration at 5 hours postdose
To estimate the magnitude of overestimation of the true circulating testosterone concentration at 5 hours postdose, when blood was collected in various tubes and the tubes were held at room temperature or on ice.
Measured: 8 days
healthy men's testosterone levels in serum and plasma
To compare healthy men's testosterone levels in serum and plasma from Plain and EDTA tubes, respectively
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start15 Jul 2018
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypogonadism, MaleStudies 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clarus Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion; Syneos Health; ARUP Laboratories
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973840
- Sponsor's protocol ID
- CLAR-18019
- Status last verified
- Jul 2019
- First submitted
- 2 Jun 2019
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess Post-collection Conversion of Testosterone Undecanoate (TU) to Testosterone in Blood From Men Receiving Oral TU Collected Into Different Types of Sample Tubes
- ClinicalTrials.gov ID
- NCT03973840
- Acronym / sponsor ID
- CLAR-18019
- Conditions
- Hypogonadism, Male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Clarus Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Celerion; Syneos Health; ARUP Laboratories
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To describe the rate of post-collection TU to testosterone conversion, as manifested by increases in testosterone concentration, in Plain tubes held at room temperature and sodium fluoride (NaF)-ethylenediaminetetraacetic acid (EDTA) tubes held at room temperature or on ice prior to centrifugation
Detailed description
This was an open-label, non-randomized, single-sequence study in which men dosed with JATENZO had blood drawn into 3 different types of blood-collection tubes (ie, Plain, EDTA, and NaF-EDTA). These tubes were then processed in different ways (ie, different durations between phlebotomy and centrifugation, different holding temperatures [room temperature or on ice] between phlebotomy and centrifugation). After defined periods of incubation, the tubes were centrifuged and the serum/plasma transferred into vials and frozen. The testosterone and TU levels in the serum/plasma were then measured using validated liquid chromatography/tandem mass spectrometry assays.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy men treatment arm | Experimental | Drug: Testosterone UndecanoateSubjects were given 15 doses over 8 days, and then blood was drawn into several types of collection tubes at different storage conditions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects were required to meet all of the following criteria in order to be eligible for the study:
- Male (gender at birth) 18 to 65 years of age, inclusive, and legally able to give informed consent, as applicable by law. The percentage of non-Hispanic and Hispanic men was specified to be approximately ≥ 70% and ≤ 30%, respectively.
- Adequate venous access in the left or right arm to allow collection of a number of blood samples via a venous cannula or needle sticks
- Naïve to androgen-replacement therapy
- Willing to consume the entire protocol-specified breakfast and dinner meals
Key exclusion criteria (17 listed)
- Subjects who met any of the following criteria were not eligible for participation in this study:
- History of hypertension or taking anti-hypertensive medications
- Intercurrent disease deemed clinically significant, in the opinion of the Investigator, of any type; in particular, liver, kidney, uncontrolled or poorly controlled heart disease, including congestive heart failure, coronary heart disease, heart attack or cerebrovascular accident in prior 6 months, or psychiatric-illness, including severe depression
- Electrocardiogram which Principal Investigator, or designate, believed was clinically significantly abnormal
- Intercurrent process or disease which could have impacted the absorption of JATENZO, in particular vomiting, nausea, diarrhea, or inflammatory bowel disease
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 Undecanoatedose was given orally and allowed to reach steady state | Drug | healthy men treatment arm |
Primary outcome
measure rate of post-collection TU-to-testosterone conversion in 3 types of collection tubes
Time frame: 8 days
To describe the rate of post-collection TU to testosterone conversion, as manifested by increases in testosterone concentration, in Plain tubes held at room temperature and sodium fluoride (NaF)-ethylenediaminetetraacetic acid (EDTA) tubes held at room temperature or on ice prior to centrifugation
3 secondary outcomes
rate of post-collection TU-to-testosterone conversion, as manifested by increases in testosterone concentration, in EDTA and NaF-EDTA collection tubes
Time frame: 8 days
magnitude of overestimation of the true circulating testosterone concentration at 5 hours postdose
Time frame: 8 days
healthy men's testosterone levels in serum and plasma
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Testosterone Undecanoate in people with Hypogonadism, Male, 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 7 inclusion and 17 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 Jul 2019. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
measure rate of post-collection TU-to-testosterone conversion in 3 types of collection tubes (time frame: 8 days). 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 Jul 2019.