A Phase 1 interventional study of Testosterone Undecanoate in Hypogonadism, Male, sponsored by Clarus Therapeutics, Inc.. Completed at 1 site in United States. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-09.
Sponsored by Clarus Therapeutics, Inc. · Phase 1, Interventional, and Diagnostic
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
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.
75 studies on the registry are indexed under Eunuchism; 21 are open to participants now.
This study's enrollment of 13 is below the median of 60 across 55 interventional studies indexed under Eunuchism.
Browse Eunuchism studies →Clarus Therapeutics, Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects were required to meet all of the following criteria in order to be eligible for the study:
Exclusion Criteria:
Subjects who met any of the following criteria were not eligible for participation in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects were given 15 doses over 8 days, and then blood was drawn into several types of collection tubes at different storage conditions.
Drug: Testosterone Undecanoate
dose was given orally and allowed to reach steady state
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
Time frame: 8 days
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
Time frame: 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.
Time frame: 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
Time frame: 8 days
Incidence of Treatment-Emergent Adverse Events
To characterize the safety and tolerability of JATENZO
Time frame: 8 days
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2018 to primary completion in Jul 2018, 0 months.
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Studies of the drug tested here: Testosterone undecanoate
Clarus Therapeutics, Inc.