Clinical Evaluation of Subcutaneous Testosterone Implants in Men With Symptomatic Hypogonadism

NCT07500766 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 88009225.0.0000.0068
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction: Male hypogonadism is a clinical syndrome associated with significant consequences for health and quality of life. In Brazil, approved testosterone replacement therapy options are limited to injectable formulations and transdermal gels, which are often associated with suboptimal adherence. Subcutaneous testosterone implants, already used in the United States and recommended by international guidelines, represent a promising alternative but are not yet available in Brazil. Objective: To evaluate the efficacy, safety, pharmacokinetics, and quality-of-life impact of 200 mg testosterone implants manufactured in Brazil for the treatment of men with symptomatic hypogonadism. Methods: This is a prospective interventional study conducted at the Division of Urology of the Hospital das Clínicas, University of São Paulo School of Medicine (FMUSP). Thirty cisgender hypogonadal men meeting strict inclusion and exclusion criteria will be enrolled. Participants will receive subcutaneous testosterone implants totaling 800 mg and will be followed for six months. Serial blood sampling will be performed to assess hormonal levels (total and free testosterone, LH, FSH, and PSA) and metabolic parameters (lipid profile, body mass index, and waist circumference). Validated questionnaires, including the IIEF-15, ADAM, and WHOQOL-BREF, will be used to evaluate sexual function, hypogonadal symptoms, quality of life, and patient satisfaction. Outcomes: The primary outcome is the ability of the implants to achieve and maintain therapeutic serum testosterone levels (450-800 ng/dL). Secondary outcomes include pharmacokinetic profile (Cmax, half-life, and mean duration), metabolic effects, changes in quality of life, and treatment adherence. Clinical Significance: This study advances the understanding of a testosterone replacement modality that may offer greater convenience for selected patients and for which data on nationally manufactured products are currently lacking. Over a six-month period, the study will investigate laboratory behavior, clinical impact, and patient satisfaction. Relevance and Impact: This is the first study of its kind conducted in Brazil, combining methodological rigor with a robust design to evaluate the safety and efficacy of domestically manufactured testosterone implants. The methodology incorporates detailed ethical and scientific criteria, ensuring high-quality data. The results may support regulatory and clinical decision-making, benefiting patients and potentially contributing to the Brazilian Unified Health System (SUS).

Conditions

Male Hypogonadism; Testosterone Deficiency; Testosterone Replacement Therapy; Testosterone

Keywords

testosterone pharmacokinetics; testosterone pharmacodynamics; testosterone pellets

Outcome Measures

Primary Outcomes (1)

• Testosterone 200mg implants in hypogonadal men pharmacokinetics

  To evaluate the efficacy of a resorbable subcutaneous testosterone implant (200 mg), administered at a total dose of 800 mg (four 200-mg implants), in achieving and maintaining total serum testosterone concentration between 450 and 800 ng/dL in symptomatic hypogonadal men over a 180-day period

  180 days

Secondary Outcomes (19)

• Maximum Plasma Testosterone Concentration

  Up to 180 days

• Time to Maximum Plasma Testosterone Concentration (Tmax)

  Up to 180 days

• Plasma Testosterone Elimination Half-Life (T½)

  Up to 180 days

• Average Plasma Testosterone Concentration (Cavg)

  Up to 180 days

• Area Under the Plasma Concentration-Time Curve

  Up to 180 days

Study Arms (1)

Subcutaneous Testosterone Implants

EXPERIMENTAL

Subcutaneous Testosterone Implants in Men With Symptomatic Hypogonadism

Drug: Subcutaneous Testosterone Implants

Interventions

Subcutaneous Testosterone Implants DRUG

Subcutaneous Testosterone Implants in Men With Symptomatic Hypogonadism

Subcutaneous Testosterone Implants

Eligibility Criteria

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

You may qualify if:

• Absence of desire for future fertility.
• Two fasting total testosterone measurements ≤ 350 ng/dL obtained between 6:00 and 10:00 a.m.

You may not qualify if:

• Inability to complete or respond to study questionnaires.
• Body mass index (BMI) \> 35 kg/m².
• Untreated depression, defined as a Beck Depression Inventory score \> 20.
• Personal history of cancer.
• Suspicious findings on digital rectal examination or breast examination.
• Prostate-specific antigen (PSA) \> 4 ng/mL.
• History of thrombosis.
• Known thrombophilia.
• Erythrocytosis.
• Polycythemia.
• Elevated liver enzymes (AST or ALT \> 1.5 times the upper limit of normal).
• Untreated chronic disease.
• Heart failure classified as New York Heart Association (NYHA) class III or IV.
• History of cardiovascular disease within the previous 6 months.
• Substance use disorder or alcohol dependence.

Sponsors & Collaborators

• University of Sao Paulo: lead

Related Publications (6)

• Smith RP, Khanna A, Coward RM, Rajanahally S, Kovac JR, Gonzales MA, Lipshultz LI. Factors influencing patient decisions to initiate and discontinue subcutaneous testosterone pellets (Testopel) for treatment of hypogonadism. J Sex Med. 2013 Sep;10(9):2326-33. doi: 10.1111/jsm.12226. Epub 2013 Jul 16.

  PMID: 23859250 BACKGROUND

• McMahon CG, Shusterman N, Cohen B. Pharmacokinetics, Clinical Efficacy, Safety Profile, and Patient-Reported Outcomes in Patients Receiving Subcutaneous Testosterone Pellets 900 mg for Treatment of Symptoms Associated With Androgen Deficiency. J Sex Med. 2017 Jul;14(7):883-890. doi: 10.1016/j.jsxm.2017.04.734.

  PMID: 28673432 BACKGROUND

• Kaminetsky JC, Moclair B, Hemani M, Sand M. A phase IV prospective evaluation of the safety and efficacy of extended release testosterone pellets for the treatment of male hypogonadism. J Sex Med. 2011 Apr;8(4):1186-96. doi: 10.1111/j.1743-6109.2010.02196.x. Epub 2011 Jan 26.

  PMID: 21269402 BACKGROUND

• Cavender RK, Fairall M. Subcutaneous testosterone pellet implant (Testopel) therapy for men with testosterone deficiency syndrome: a single-site retrospective safety analysis. J Sex Med. 2009 Nov;6(11):3177-92. doi: 10.1111/j.1743-6109.2009.01513.x. Epub 2009 Sep 29.

  PMID: 19796052 BACKGROUND

• Kresch E, Lima TFN, Molina M, Deebel NA, Reddy R, Patel M, Loloi J, Carto C, Nackeeran S, Gonzalez DC, Ory J, Ramasamy R. Efficacy and safety outcomes of a compounded testosterone pellet versus a branded testosterone pellet in men with testosterone deficiency: a single-center, open-label, randomized trial. Sex Med. 2023 Mar 17;11(2):qfad007. doi: 10.1093/sexmed/qfad007. eCollection 2023 Apr.

  PMID: 36936900 BACKGROUND

• McCullough A. A Review of Testosterone Pellets in the Treatment of Hypogonadism. Curr Sex Health Rep. 2014;6(4):265-269. doi: 10.1007/s11930-014-0033-7.

  PMID: 25999802 BACKGROUND

MeSH Terms

Conditions

Eunuchism

Condition Hierarchy (Ancestors)

Hypogonadism; Gonadal Disorders; Endocrine System Diseases

Central Study Contacts

Bruno N PhD, MD

CONTACT

+5511999686655; bruno.nascimento@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Implant of four BIOS testosterone pellets of 200mg in hypogonadal man and followup with pharmacokinetics of the response

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 30, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share