Jatenzo (testosterone undecanoate) / Tolmar - LARVOL DELTA

Testosterone Treatment in Men with Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: St. Louis University | Trial completion date: Dec 2026 ➔ Dec 2028 | Trial primary completion date: Jun 2026 ➔ Jun 2028

Trial completion date • Trial primary completion date • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Renal Disease

A Phase 4 Study to Evaluate Adrenal Function in Hypogonadal Men Treated With JATENZO® for 12 Months (clinicaltrials.gov) - P4 | N=110 | Active, not recruiting | Sponsor: Tolmar Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Endocrine Disorders

SI01-08. The State of TRT: Feeling the Impact of Trends in Practice and Patient Care (ENDO 2024) - "DESCRIPTION Join us for a presentation and discussion on the results of an inaugural landmark TRT Sermo survey of 303 Endocrinologists, Urologists, PCPs and other specialists sponsored by JATENZO® (testosterone undecanoate) capsules. For questions about how the sponsor will handle your information or to unsubscribe from their marketing communications, please contact the sponsor directly or refer to its privacy policy. For questions related to how the Endocrine Society shares information, please refer to the Society's Privacy Policy."

Clinical • Urology

A Phase 4 Study to Evaluate Adrenal Function in Hypogonadal Men Treated With JATENZO® for 12 Months (clinicaltrials.gov) - P4 | N=110 | Recruiting | Sponsor: Tolmar Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Endocrine Disorders

A Phase 4 Study to Evaluate Adrenal Function in Hypogonadal Men Treated With JATENZO® for 12 Months (clinicaltrials.gov) - P4 | N=110 | Not yet recruiting | Sponsor: Tolmar Inc.

New P4 trial • Endocrine Disorders

Testosterone Treatment in Men With Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: St. Louis University | Trial completion date: Dec 2024 ➔ Dec 2026 | Trial primary completion date: Jun 2024 ➔ Jun 2026

Trial completion date • Trial primary completion date • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Renal Disease

Patient Satisfaction After Switching to Oral Testosterone Undecanoate (clinicaltrials.gov) - P4 | N=41 | Completed | Sponsor: University of Miami | Active, not recruiting ➔ Completed | Trial completion date: Jun 2024 ➔ Apr 2023 | Trial primary completion date: Dec 2023 ➔ Apr 2023

Trial completion • Trial completion date • Trial primary completion date

Erythrocytosis Associated with Oral Testosterone Replacement (ENDO 2023) - "Defined by hematocrit (HCT) > 49-51%, the incidence varies depending on the testosterone formulation.3 The formulations with the lowest risk of erythrocytosis are intranasal testosterone (0-2%) and oral testosterone (0.03%).3 A phase 3 clinical trial of testosterone undecanoate (Jatenzo) reported 4.8% patients experienced an increase in hematocrit, although not severe enough to warrant therapy discontinuation.2 We present a case of erythrocytosis with oral testosterone undecanoate that prompted a change in therapy... We present a case of oral testosterone undecanoate complicated by persistent erythrocytosis despite dose reduction. Testing for contributing etiology was unrevealing. Oral testosterone replacement is considered the formulation least likely to cause erythrocytosis."

Diabetes • Endocrine Disorders • Genetic Disorders • Hematological Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus • AR

Patient Satisfaction After Switching to Oral Testosterone Undecanoate (clinicaltrials.gov) - P4 | N=40 | Active, not recruiting | Sponsor: University of Miami | Trial completion date: Dec 2023 ➔ Jun 2024 | Trial primary completion date: Jun 2023 ➔ Dec 2023

Trial completion date • Trial primary completion date

Two-Year Analysis of a New Oral Testosterone Undecanoate (TU) Formulation in Hypogonadal Men: Efficacy, Impact on Psychosexual Function, and Safety. (PubMed, J Sex Med) - "Oral TU offers a safe and effective long-term treatment option for men with hypogonadism."

Journal • Cardiovascular • Endocrine Disorders

Safety Aspects and Rational Use of Testosterone Undecanoate in the Treatment of Testosterone Deficiency: Clinical Insights. (PubMed, Drug Healthc Patient Saf) - "Oral testosterone undecanoate is marketed as Andriol, Jatenzo, Tlando, and Kyzatrex. This review describes the pharmacokinetics of these testosterone undecanoate products and provides a guide for prescribers using these medications. While many forms of testosterone are appropriate for TT, a patient-centered discussion focused on goals of care should best guide physician prescription of these medications."

Journal • Review • Endocrine Disorders

Testosterone Treatment in Men With Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: St. Louis University | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Jun 2023 ➔ Jun 2024

Trial completion date • Trial primary completion date • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Renal Disease

Patient Satisfaction After Switching to Oral Testosterone Undecanoate in Men Currently Receiving Testosterone Therapy: An Open-Label Single-Center Phase IV Clinical Trial (AUA 2022) - P4 | "Jatenzo® is a novel US FDA approved formulation of oral T undecanoate that provides a uniform response...Conclusions : Oral T undecanoate appears to provide similar patient satisfaction and similar improvement in TD symptoms as other forms of TT. In addition, it increases serum total T to the normal range (300 – 1000ng/dL) in > 90% of men without a difference in side effect profile."

Clinical • P4 data • Pain

Testosterone Replacement Therapy: A Narrative Review with a Focus on New Oral Formulations. (PubMed, touchREV Endocrinol) - "Based on unique chemistry using a self-emulsifying drug delivery system and lymphatic absorption, JATENZO and TLANDO address some of the limitations of other dosing routes while providing a safe option without evidence of liver dysfunction. This review discusses various testosterone treatment options, focusing on the role and pharmacokinetics of the new oral formulations."

Journal • Review • Endocrine Disorders • Hepatology • Liver Failure

PATIENT SATISFACTION WITH ORAL TESTOSTERONE UNDECANOATE (JATENZO) IN MEN WITH PREVIOUS TESTOSTERONE THERAPY: AN OPEN-LABEL, SINGLE-CENTER, PHASE IV CLINICAL TRIAL (SESAUA 2023) - "Jatenzo appears to provide similar patient satisfaction and similar improvement in hypogonadal symptoms relative to other forms of TTh. In addition, Jatenzo increases serum total serum testosterone to reference range (300 – 1000 ng/dL) in >90% of men without a difference in side effect profile."

Clinical • P4 data

Two new oral testosterone products for hypogonadism. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Endocrine Disorders

PATIENT SATISFACTION AFTER SWITCHING TO ORAL TESTOSTERONE UNDECANOATE IN MEN CURRENTLY RECEIVING TESTOSTERONE THERAPY: AN OPEN-LABEL SINGLE-CENTER PHASE IV CLINICAL TRIAL (ASRM 2022) - "OBJECTIVE: In this study, we evaluated patient satisfaction of an oral formulation of testosterone, Jatenzo®, as compared to other forms of testosterone. Oral testosterone undecanoate appears to provide increased patient satisfaction and similar improvement in hypogonadal symptoms as other forms of testosterone therapy. In addition, it increases serum total testosterone to the normal range (300 – 1000ng/dL) in > 90% of men without a difference in side effect profile. IMPACT STATEMENT: Oral formulations of testosterone are convenient, easy to use, and avoid the problems of other forms of testosterone therapy such as painful injections and transference to women and children."

Clinical • P4 data • Pain

Patient Satisfaction After Switching to Oral Testosterone Undecanoate (clinicaltrials.gov) - P4 | N=40 | Active, not recruiting | Sponsor: University of Miami | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Jun 2023

Trial completion date • Trial primary completion date

Two-Year Analysis of a New Oral Testosterone Undecanoate (TU) Formulation in Hypogonadal Men: Efficacy, Impact on Psychosexual Function, and Safety. (PubMed, J Sex Med) - "Oral TU offers a safe and effective long-term treatment option for men with hypogonadism. Honig S, Gittelman M, Kaminetsky J, et al. Two-Year Analysis of a New Oral Testosterone Undecanoate (TU) Formulation in Hypogonadal Men: Efficacy, Impact on Psychosexual Function, and Safety. J Sex Med 2022;XX:XXX-XXX."

Journal • Cardiovascular • Endocrine Disorders

Patient Satisfaction After Switching to Oral Testosterone Undecanoate (clinicaltrials.gov) - P4 | N=40 | Active, not recruiting | Sponsor: University of Miami | Recruiting ➔ Active, not recruiting

Enrollment closed

"$CRXT $CRXTQ Clarus Therapeutics Holdings, Inc. Announces Completion of Auction for Sale of JATENZO® and Selection of Tolmar, Inc. as Successful Bidder https://t.co/sbYmVGZkE3" (@stock_titan)

Single Time Point Total Testosterone to Predict 24-Hour Average Concentration of Total Testosterone in Hypogonadal Men Treated With an Oral Testosterone Undecanoate Softgel (JATENZO�) (NEAUA 2022) - "Overall, 87.3% (95% CI: 81.3%, 92.0%) of hypogonadal men had a final Cavg in the eugonadal range, with a mean serum total T = 488.7 � 154.5 ng/dL (16.95 � 5.37 nmol/L). Pooled values from all PK days demonstrated a linear relationship between T concentrations at 4, 6, and 9 hrs and Cavg (p > 0.50), indicating consistency in results among PK visits and among sampling timepoints."

Endocrine Disorders

Patient Satisfaction After Switching to Jatenzo (Oral Testosterone Undecanoate): Update on an Open-label, Single-arm Clinical Trial. (PubMed, Eur Urol Focus) - "Oral TU appeared to lead to greater patient satisfaction in comparison to previous modalities and similar improvements in hypogonadal symptoms. TU represents a favorable and viable option for hypogonadal individuals who are unhappy with existing treatment options."

Journal

"$CRXT $CRXTW Clarus Therapeutics Holdings, Inc. Announces Plan for Near-Term Sale of JATENZO® Using Structured Process Through Chapter 11 of the U.S. Bankruptcy Code https://t.co/UA0XEFTgAY" (@stock_titan)

(PT02) An Individualized Approach to Oral Testosterone Replacement Therapy (ENDO 2022) - "In this presentation, we'll highlight how JATENZO may address some of the unmet needs of men with hypogonadism. We'll also review its unique mode of absorption, clinical study results, and individualized approach to dosing."

Clinical • Endocrine Disorders