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HypogonadismPhase 4NCT06385509

A Phase 4 Study to Evaluate Adrenal Function in Hypogonadal Men Treated With JATENZO® for 12 Months

A Phase 4 study testing Jatenzo Oral Product in people with Hypogonadism, run by Tolmar Inc. at 27 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

TOL-CLAR-20024 is a Phase 4, multi-center, open-label safety study evaluating the potential effect of JATENZO on adrenal function in hypogonadal men treated with JATENZO for 12 months. 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?
Jatenzo Oral Product
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
27 sitesUnited States
Study dates
2 Jul 2024to 25 Nov 2025
Phase
Phase 4
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must be a man 18 to 65 years of age, inclusive, with a previous clinical diagnosis of hypogonadism (signs/symptoms consistent with hypogonadism and a low T level as defined by established criteria at the time of diagnosis); subjects must also have at least 1 T level < 300 ng/dL at either Screen 1 or Screen 2.
  • Subject must be naïve to androgen replacement therapy or washed out of prior androgen replacement therapies (wash out durations specified in exclusion criterion); that is, be willing to cease current T treatment, or currently not be taking T treatment.
  • Subject agrees as part of signed informed consent to remain off all forms of T, except for dispensed study drug, throughout the entire study.
  • Subject must have adequate venous access in the left or right arm to allow collection of blood samples.
  • Subject must be able and willing to provide written informed consent and comply with the trial protocol and procedures.

Who cannot join

  • Subject will be excluded if 1 or more of the main exclusion is applicable:
  • Subject with a history of panhypopituitarism or multiple endocrine deficiencies (whether or not on stable doses of thyroid hormone and adrenal replacement hormones).
  • Subject with a current or prior history of AI.
  • Subject is currently receiving corticosteroids.
  • On the CST at Screen 3, the maximum serum total cortisol at both the 30- and 60-minute timepoint is ≤ 14 mcg/dL or has a baseline CBG outside the reference range.
  • Subject with a history of a short course (2 weeks or less) of any glucocorticoids within the past 3 months or anabolic steroids other than testosterone within the past 6 months.
Show all 37Show fewer
  • Subject with a history of a protracted course of any glucocorticoid therapy (e.g., inhaled nasal steroids, inhaled oral steroids, topical steroids, injectable steroids such as joint injections) or anabolic steroids other than T. Enrolled subjects who take glucocorticoids while on study drug may be discontinued from the study at the discretion of the investigator in consultation with the sponsor.
  • Subject with a history of anabolic steroid abuse.
  • Subject with a diagnosis of hypogonadism who has received any topical (e.g., gel or patch), intranasal, or buccal T therapy within the previous 2 weeks, intramuscular T injection of short-acting duration (e.g., T enanthate, T cypionate) within the previous 4 weeks, intramuscular T injection of long-acting duration (e.g., AVEED®) within the previous 20 weeks, T implantable pellets (Testopel®) product within the previous 6 months or any prior use of an oral testosterone product.
  • Subject has received any drug as part of another research study within 30 days of initial dose administration in this study.
  • Subject has significant intercurrent disease (e.g., liver, kidney, inflammatory bowel disease, uncontrolled or poorly controlled heart disease, including hypertension, thromboembolism, congestive heart failure, or coronary heart disease, psychiatric illness, including severe depression), which in the opinion of the Investigator, would affect study participation or interpretation of study assessments.
  • Subject has untreated, severe obstructive sleep apnea.
  • Subject has clinically significant abnormal laboratory values, including serum transaminases > 2 × upper limits of normal (ULN), serum bilirubin > 1.5 × ULN (except subjects with Gilbert syndrome) and serum creatinine > 1.5 × ULN.
  • Subject has a HCT value of < 35% or > 50%.
  • Subject has a history of polycythemia, either idiopathic or associated with TRT treatment.
  • Subject is diabetic with a glycosylated hemoglobin > 8.5%.
  • Subject has a body mass index (BMI) ≥ 38 kg/m2.
  • Subject has had a recent (within 2 years) history of stroke, transient ischemic attack, or acute coronary event.
  • Subject has a mean (triplicate assessments) systolic blood pressure (sBP) > 140 mm Hg and/or diastolic blood pressure (dBP) > 90 mm Hg at screening (if prescribed antihypertensives, subject should be taking medications on the day of the screening visit with a sip of water).
  • Subject has had recent (within 2 years) history of angina or stent (coronary or carotid) placement.
  • Subject does not meet the requirements for concomitant medication as outlined below:
  • If hypertensive, on a stable dose of antihypertensive medication for < 3 months
  • If diabetic, on a stable dose of oral medication for < 2 months
  • If on anticonvulsant therapy, on a stable dose for < 3 months
  • If on lipid lowering medications, on a stable dose for < 3 months. Subject is expected to remain on a stable dose of lipid-lowering medication(s) throughout the study.
  • Subject has an abnormal prostate DRE (palpable nodules), elevated PSA (serum PSA > 4.0 ng/mL), I-PSS > 19 points at screening.
  • Subject has a history of, or current or suspected prostate cancer.
  • Subject has a history of, or current or suspected breast cancer.
  • Subject currently using a drug known to affect T levels, T metabolism or levels of T metabolites. These include: 5-alpha-reductase inhibitors (e.g., dutasteride, finasteride), estrogens, long-acting opioid analgesics (e.g., methadone hydrochloride, buprenorphine hydrochloride), human growth hormone (HGH) or over-the-counter supplements purported to "boost" testosterone, sexual function or improve prostate symptoms.
  • Subject use of dietary supplements such as saw palmetto or phytoestrogens and any dietary supplements that may increase total T, such as androstenedione or dehydroepiandrosterone within the previous 4 weeks.
  • Subject use of any over-the-counter "adrenal supplements".
  • Subject is not willing to stop all supplemental biotin 3 days prior to testing at intervals described in this protocol.
  • Subject currently using Megace, atypical anti-psychotics (e.g., clozapine, aripiorazole, asenapine, lumateperone, olanzapine, paliperidone, aripiprazole, ziprasidone, cariprazine, risperidone, pimavanserin, ioperidone, brexpiprazole, lurasidone, quetiapine) or chronic benzodiazepine use.
  • Subject has a history of abnormal bleeding tendencies or thrombophlebitis unrelated to venipuncture or intravenous cannulation within the previous 2 years.
  • Subject has history of abuse of alcohol or any drug substance within the previous 2 years.
  • Subject deemed to be a compliance risk or unlikely to keep clinic appointments.
  • Subject donated blood (≥ 500 mL) within the 12-week period before the initial study dose.

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

United States27 sites

  • Velocity Clinical Research

    Austin, Texas, 78759

  • Alpine Research Organization, Inc.

    Clinton, Utah, 84015

  • Centennial Medical Group

    Columbia, Maryland, 21045

  • Hillcrest Medical Research, LLC

    DeLand, Florida, 32720

  • Epic Medical Research LLC

    DeSoto, Texas, 75115

  • Velocity Clinical Research, Inc.

    Durham, North Carolina, 27701

  • AccuMed Research Associates

    Garden City, New York, 11530

  • VAST Clinical Research LLC

    Garland, Texas, 75041

  • Catawba Valley Medical Group, Inc.

    Hickory, North Carolina, 28602

  • Clinical Investigation Specialists, Inc.

    Kenosha, Wisconsin, 53144

  • Clinical Trials Research

    Lincoln, California, 95648

  • Long Beach Research Institute, LLC

    Long Beach, California, 90805

  • SMS Clinical Research LLC

    Mesquite, Texas, 75149

  • Global Health Clinical Trial Crop

    Miami, Florida, 33135

  • Reserka LLC

    Miami, Florida, 33176

  • Alliance for Multispecialty Research

    Norfolk, Virginia, 23507

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Velocity Clinical Research

    Omaha, Nebraska, 68134

  • Clinical Research Center of Florida

    Pompano Beach, Florida, 33060

  • Raleigh Medical Group

    Raleigh, North Carolina, 27609

  • Rochester Clinical Research, LLC

    Rochester, New York, 14609

  • Highland Clinical Research

    Salt Lake City, Utah, 84124

  • Velocity Clinical Research

    Savannah, Georgia, 31406

  • Piedmont Healthcare, PA

    Statesville, North Carolina, 28625

  • Integrated Clinical Research

    Tarzana, California, 91356

  • Alliance for Multispecialty Research

    Tempe, Arizona, 85281

  • Wilmington Health, PLLC

    Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: A Phase 4, Open-Label Study to Evaluate Primary Adrenal Function (Glucocorticoid Axis) in Hypogonadal Men Treated With JATENZO® for 12 Months

TOL-CLAR-20024 is a Phase 4, multi-center, open-label safety study evaluating the potential effect of JATENZO on adrenal function in hypogonadal men treated with JATENZO for 12 months.

Read the detailed description

Following all screening activities and confirmation that the subject has met all eligibility requirements, JATENZO treatment for approximately 1 year will begin. The dose of JATENZO will be titrated using its standard dose-titration algorithms based on serum testosterone levels. The Treatment Period will consist of Visits 1 - 12, with cosyntropin stimulation test completed at Visit 9 (Day 169 ±7) and Visit 12 (Day 365 ±7). At each visit during the Treatment Period, subjects will be evaluated for signs and symptoms of adrenal insufficiency, occurrence of adverse events, and changes in concomitant medications. There will be a safety follow-up visit 2 weeks after completion of Visit 12.

Conditions
Hypogonadism
Being tested
Jatenzo Oral Product
Medical subject headings
Hypogonadism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Jatenzo Oral ProductDrug

    158 mg JATENZO 198 mg JATENZO 237 mg JATENZO

Study groups in NCT06385509
Study groupRoleWhat they receive
JATENZO® twice dailyExperimentalJATENZO capsules will be provided in 3 dosage strengths: 158 mg, 198 mg, 237 mg twice daily
Receives: Drug: Jatenzo Oral Product

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CST Test

    To estimate the proportion of subjects with an abnormal post-stimulation cosyntropin stimulation test (CST) serum total cortisol level after approximately 6 and 12 months of treatment with JATENZO

    Measured: 6 months and 12 months

Secondary outcomes (1)

  1. Adrenal Insufficiency

    To estimate the proportion of subjects who develop primary adrenal insufficiency (AI) as assessed by clinical symptoms of AI and laboratory assessment of cortisol production after approximately 12 months of treatment with JATENZO

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2024
  2. Study start2 Jul 2024
  3. Primary completion25 Nov 2025
  4. Study completion25 Nov 2025

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06385509
Sponsor's protocol ID
TOL-CLAR-20024
Status last verified
Jun 2026
First submitted
19 Apr 2024
Last updated
2 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Jatenzo Oral Product in people with Hypogonadism, run by Tolmar 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 5 inclusion and 37 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 2 Oct 2026. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

CST Test (time frame: 6 months and 12 months). 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 NCT06385509.

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 2 Oct 2026.

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