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12개월 동안 JATENZO®로 치료받은 생식선 기능 저하 남성의 부신 기능을 평가하기 위한 4상 연구

2026년 9월 28일 업데이트: Tolmar Inc.

12개월 동안 JATENZO®로 치료받은 생식선 기능 저하증 남성의 주요 부신 기능(글루코코르티코이드 축)을 평가하기 위한 제4상 공개 라벨 연구

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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

116

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

남성

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: JATENZO® twice daily

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

158 mg JATENZO 198 mg JATENZO 237 mg JATENZO

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
CST Test
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Adrenal Insufficiency
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Hormone changes
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Tolmar Inc.

협력자

ICON plc

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 7월 2일

기본 완료 (실제)

2025년 11월 25일

연구 완료 (실제)

2025년 11월 25일

연구 등록 날짜

최초 제출

2024년 4월 19일

QC 기준을 충족하는 최초 제출

2024년 4월 23일

처음 게시됨 (실제)

2024년 4월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 28일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • TOL-CLAR-20024

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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