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JATENZO®を12か月間投与した性腺機能低下症の男性の副腎機能を評価する第4相研究

2026年9月28日 更新者：Tolmar Inc.

JATENZO®で12か月間治療を受けた性腺機能低下症の男性の一次副腎機能（グルココルチコイド軸）を評価する第4相非盲検試験

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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

116

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Arizona
      • Tempe、Arizona、アメリカ、85281
        • Alliance for Multispecialty Research
    • California
      • Lincoln、California、アメリカ、95648
        • Clinical Trials Research
      • Long Beach、California、アメリカ、90805
        • Long Beach Research Institute, LLC
      • Tarzana、California、アメリカ、91356
        • Integrated Clinical Research
    • Florida
      • DeLand、Florida、アメリカ、32720
        • Hillcrest Medical Research, LLC
      • Miami、Florida、アメリカ、33135
        • Global Health Clinical Trial Crop
      • Miami、Florida、アメリカ、33176
        • Reserka LLC
      • Ocala、Florida、アメリカ、34470
        • Renstar Medical Research
      • Pompano Beach、Florida、アメリカ、33060
        • Clinical Research Center of Florida
    • Georgia
      • Savannah、Georgia、アメリカ、31406
        • Velocity Clinical Research
    • Maryland
      • Columbia、Maryland、アメリカ、21045
        • Centennial Medical Group
    • Nebraska
      • Omaha、Nebraska、アメリカ、68134
        • Velocity Clinical Research
    • New York
      • Garden City、New York、アメリカ、11530
        • AccuMed Research Associates
      • Rochester、New York、アメリカ、14609
        • Rochester Clinical Research, LLC
    • North Carolina
      • Durham、North Carolina、アメリカ、27701
        • Velocity Clinical Research, Inc.
      • Hickory、North Carolina、アメリカ、28602
        • Catawba Valley Medical Group, Inc.
      • Raleigh、North Carolina、アメリカ、27609
        • Raleigh Medical Group
      • Statesville、North Carolina、アメリカ、28625
        • Piedmont Healthcare, PA
      • Wilmington、North Carolina、アメリカ、28401
        • Wilmington Health, PLLC
    • Texas
      • Austin、Texas、アメリカ、78759
        • Velocity Clinical Research
      • DeSoto、Texas、アメリカ、75115
        • Epic Medical Research LLC
      • Garland、Texas、アメリカ、75041
        • VAST Clinical Research LLC
      • Mesquite、Texas、アメリカ、75149
        • SMS Clinical Research LLC
    • Utah
      • Clinton、Utah、アメリカ、84015
        • Alpine Research Organization, Inc.
      • Salt Lake City、Utah、アメリカ、84124
        • Highland Clinical Research
    • Virginia
      • Norfolk、Virginia、アメリカ、23507
        • Alliance for Multispecialty Research
    • Wisconsin
      • Kenosha、Wisconsin、アメリカ、53144
        • Clinical Investigation Specialists, Inc.

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～65年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

男

説明

Inclusion Criteria:

  1. 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.
  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.
  3. Subject agrees as part of signed informed consent to remain off all forms of T, except for dispensed study drug, throughout the entire study.
  4. Subject must have adequate venous access in the left or right arm to allow collection of blood samples.
  5. Subject must be able and willing to provide written informed consent and comply with the trial protocol and procedures.

Exclusion Criteria:

  • Subject will be excluded if 1 or more of the main exclusion is applicable:

    1. Subject with a history of panhypopituitarism or multiple endocrine deficiencies (whether or not on stable doses of thyroid hormone and adrenal replacement hormones).

    2. Subject with a current or prior history of AI.

    3. Subject is currently receiving corticosteroids.

    4. 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.

    5. 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.

    6. 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.

    7. Subject with a history of anabolic steroid abuse.

    8. 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.

    9. Subject has received any drug as part of another research study within 30 days of initial dose administration in this study.

    10. 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.

    11. Subject has untreated, severe obstructive sleep apnea.

    12. 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.

    13. Subject has a HCT value of < 35% or > 50%.

    14. Subject has a history of polycythemia, either idiopathic or associated with TRT treatment.

    15. Subject is diabetic with a glycosylated hemoglobin > 8.5%.

    16. Subject has a body mass index (BMI) ≥ 38 kg/m2.

    17. Subject has had a recent (within 2 years) history of stroke, transient ischemic attack, or acute coronary event.

    18. 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).

    19. Subject has had recent (within 2 years) history of angina or stent (coronary or carotid) placement.

    20. Subject does not meet the requirements for concomitant medication as outlined below:

      1. If hypertensive, on a stable dose of antihypertensive medication for < 3 months
      2. If diabetic, on a stable dose of oral medication for < 2 months
      3. If on anticonvulsant therapy, on a stable dose for < 3 months
      4. 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.

    21. Subject has an abnormal prostate DRE (palpable nodules), elevated PSA (serum PSA > 4.0 ng/mL), I-PSS > 19 points at screening.

    22. Subject has a history of, or current or suspected prostate cancer.

    23. Subject has a history of, or current or suspected breast cancer.

    24. 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.

    25. 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.

    26. Subject use of any over-the-counter "adrenal supplements".

    27. Subject is not willing to stop all supplemental biotin 3 days prior to testing at intervals described in this protocol.

    28. 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.

    29. Subject has a history of abnormal bleeding tendencies or thrombophlebitis unrelated to venipuncture or intravenous cannulation within the previous 2 years.

    30. Subject has history of abuse of alcohol or any drug substance within the previous 2 years.

    31. Subject deemed to be a compliance risk or unlikely to keep clinic appointments.

    32. Subject donated blood (≥ 500 mL) within the 12-week period before the initial study dose.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：JATENZO® twice daily

JATENZO capsules will be provided in 3 dosage strengths: 158 mg, 198 mg, 237 mg twice daily
薬：Jatenzo Oral Product

158 mg JATENZO 198 mg JATENZO 237 mg JATENZO

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
CST Test
時間枠：6 months and 12 months

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
6 months and 12 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Adrenal Insufficiency
時間枠：12 months

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
12 months

その他の成果指標

結果測定
メジャーの説明
時間枠
Hormone changes
時間枠：3 months and 6 months

To estimate the changes from baseline in estrogen (E), follicle stimulating hormone (FSH), and luteinizing hormon (LH) after approximately 3 and 6 months of treatment with JATENZO
3 months and 6 months
Sperm analysis
時間枠：3 months and 6 months

To estimate the changes from baseline in sperm concentration, sperm motility, and total motile sperm count (TMSC) after approximately 3 and 6 months of treatment with JATENZO
3 months and 6 months
Testis volume analysis
時間枠：3 months and 6 months

To estimate the changes from baseline in testicular size after approximately 3 and 6 months of treatment with JATENZO
3 months and 6 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Tolmar Inc.

協力者

ICON plc

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年7月2日

一次修了 (実際)

2025年11月25日

研究の完了 (実際)

2025年11月25日

試験登録日

最初に提出

2024年4月19日

QC基準を満たした最初の提出物

2024年4月23日

最初の投稿 (実際)

2024年4月26日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月2日

QC基準を満たした最後の更新が送信されました

2026年9月28日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • TOL-CLAR-20024

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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