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

NCT06385509 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: TOL-CLAR-20024
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 27

Brief 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.

Conditions

Hypogonadism

Outcome Measures

Primary Outcomes (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

  6 months and 12 months

Secondary Outcomes (1)

• Adrenal Insufficiency

  12 months

Other Outcomes (7)

• Estrogen changes

  3 months and 6 months

• Follicle Stimulating Hormone (FSH) changes.

  3 months and 6 months

• Luteinizing hormone (LH) changes

  3 months and 6 months

Study Arms (1)

JATENZO® twice daily

EXPERIMENTAL

Participants receive 237 mg JATENZO twice daily, with the potential to be titrated to a higher or lower dose depending on serum testosterone levels.

Drug: Jatenzo

Interventions

Jatenzo DRUG

237 mg JATENZO twice daily

JATENZO® twice daily

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.
• 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%.

Sponsors & Collaborators

• Tolmar Inc.: lead
• ICON plc: collaborator

Study Sites (27)

Alliance for Multispecialty Research

Tempe, Arizona, 85281, United States

Location

Clinical Trials Research

Lincoln, California, 95648, United States

Location

Long Beach Research Institute, LLC

Long Beach, California, 90805, United States

Location

Integrated Clinical Research

Tarzana, California, 91356, United States

Location

Hillcrest Medical Research, LLC

DeLand, Florida, 32720, United States

Location

Global Health Clinical Trial Crop

Miami, Florida, 33135, United States

Location

Reserka LLC

Miami, Florida, 33176, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States

Location

Velocity Clinical Research

Savannah, Georgia, 31406, United States

Location

Centennial Medical Group

Columbia, Maryland, 21045, United States

Location

Velocity Clinical Research

Omaha, Nebraska, 68134, United States

Location

AccuMed Research Associates

Garden City, New York, 11530, United States

Location

Rochester Clinical Research, LLC

Rochester, New York, 14609, United States

Location

Velocity Clinical Research, Inc.

Durham, North Carolina, 27701, United States

Location

Catawba Valley Medical Group, Inc.

Hickory, North Carolina, 28602, United States

Location

Raleigh Medical Group

Raleigh, North Carolina, 27609, United States

Location

Piedmont Healthcare, PA

Statesville, North Carolina, 28625, United States

Location

Wilmington Health, PLLC

Wilmington, North Carolina, 28401, United States

Location

Velocity Clinical Research

Austin, Texas, 78759, United States

Location

Epic Medical Research LLC

DeSoto, Texas, 75115, United States

Location

VAST Clinical Research LLC

Garland, Texas, 75041, United States

Location

SMS Clinical Research LLC

Mesquite, Texas, 75149, United States

Location

Alpine Research Organization, Inc.

Clinton, Utah, 84015, United States

Location

Highland Clinical Research

Salt Lake City, Utah, 84124, United States

Location

Alliance for Multispecialty Research

Norfolk, Virginia, 23507, United States

Location

Clinical Investigation Specialists, Inc.

Kenosha, Wisconsin, 53144, United States

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

Testosterone Propionate

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Testosterone; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 26, 2024
• Study Start: May 10, 2024
• Primary Completion: November 1, 2025
• Study Completion: March 1, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (27)