Male HypogonadismPhase 2NCT07500766
Clinical Evaluation of Subcutaneous Testosterone Implants in Men With Symptomatic Hypogonadism
A Phase 2 study testing Subcutaneous Testosterone Implants in people with Male Hypogonadism and Testosterone Deficiency, run by University of Sao Paulo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Male Hypogonadism, Testosterone Deficiency, Testosterone Replacement Therapy
- What is being tested?
- Subcutaneous Testosterone Implants
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Apr 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Absence of desire for future fertility.
- Two fasting total testosterone measurements ≤ 350 ng/dL obtained between 6:00 and 10:00 a.m.
- A positive ADAM questionnaire result (Participants with a prior diagnosis of testosterone deficiency established at this institution who are currently receiving testosterone replacement therapy and wish to participate in the study will be eligible for inclusion after completion of an appropriate washout period of the testosterone formulation in use.)
Who cannot join
- 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.
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- 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.
- Use of antiandrogen medications (flutamide, bicalutamide, enzalutamide, apalutamide, spironolactone, cyproterone acetate, abiraterone, ketoconazole, dutasteride, finasteride).
- Use of estrogenic medications (estradiol, conjugated estrogens, progestogens).
- Use of anabolic androgenic steroids without medical indication.
- Untreated hypothyroidism.
- Known allergy or hypersensitivity to testosterone or any component of the implant (testosterone, stearic acid).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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
- Being tested
- Subcutaneous Testosterone Implants
- Keywords
- testosterone pharmacokinetics, testosterone pharmacodynamics, testosterone pellets
- Medical subject headings
- Eunuchism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous Testosterone ImplantsDrug
Subcutaneous Testosterone Implants in Men With Symptomatic Hypogonadism
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous Testosterone Implants | Experimental | Subcutaneous Testosterone Implants in Men With Symptomatic Hypogonadism Receives: Drug: Subcutaneous Testosterone Implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 180 days
Secondary outcomes (19)
Maximum Plasma Testosterone Concentration
Assessment of the maximum plasma concentration of total testosterone.
Measured: Up to 180 days
Time to Maximum Plasma Testosterone Concentration (Tmax)
Assessment of the time required to reach the maximum plasma concentration of total testosterone after implantation.
Measured: Up to 180 days
Plasma Testosterone Elimination Half-Life (T½)
Assessment of the elimination half-life of total testosterone in plasma following implantation.
Measured: Up to 180 days
Average Plasma Testosterone Concentration (Cavg)
Assessment of the average plasma concentration of total testosterone following implantation.
Measured: Up to 180 days
Area Under the Plasma Concentration-Time Curve
Assessment of the area under the curve of plasma concentration.
Measured: Up to 180 days
To evaluate the safety profile of testosterone implants.
Evaluate the incidence of complications in a clavien dindo scale
Measured: 180 days
Change in Serum Luteinizing Hormone (LH) Levels
Assessment of changes in serum luteinizing hormone (LH) levels during treatment with testosterone implants.
Measured: Up to 180 days
Evaluation of sexual outcomes
To evaluate the incidence of erectile dysfunction withe the International Index of Erectile Function.
Measured: 180 days
Evaluation of coagulation after testosterone implants
Evaluate the plasma thromboelastography in men treated with testosterone implants.
Measured: 180 days
Change in Hypogonadal Symptoms Assessed by the Androgen Deficiency in the Aging Male Questionnaire
Assessment of changes in hypogonadal symptoms using the Androgen Deficiency in the Aging Male questionnaire.
Measured: Up to 180 days
To evaluate changes in quality of life in hypogonadal patients undergoing testosterone replacement therapy with implants
To evaluate changes in quality of life in hypogonadal patients undergoing testosterone replacement therapy with implants with the World Health Organization Quality of Life - BREF (WHOQOL-BREF) assessment questionnaire score.
Measured: 180 days
To evaluate the metabolic effects of testosterone implants using serum lipid profile
To evaluate the metabolic effects of testosterone implants on the serum lipid profile
Measured: 180 days
To assess patient satisfaction with testosterone implant therapy.
To assess patient satisfaction with a numerical Likert scale 1 to 5
Measured: 180 days
To compare patient satisfaction with testosterone implants versus other testosterone replacement therapy modalities previously used by the participants.
To compare patient satisfaction with testosterone implants versus other testosterone replacement therapy modalities previously used by the participants, with a qualitative comprehensive questionnaire and a numerical final grade from 1 to 100
Measured: 180 days
Change in Serum Follicle-Stimulating Hormone (FSH) Levels
Assessment of changes in serum follicle-stimulating hormone (FSH) levels during treatment with testosterone implants.
Measured: Up to 180 days
Change in Prostate-Specific Antigen (PSA) Levels
Assessment of changes in serum prostate-specific antigen (PSA) levels during treatment with testosterone implants.
Measured: Up to 180 days
To evaluate patient regret with testosterone implant treatment
Evaluate the incidence of regret in the use of testosterone implant treatment in a 1-5 Likert scale.
Measured: 180 days
To evaluate the metabolic effects of testosterone implants on body mass index (BMI)
To evaluate the metabolic effects of testosterone implants on body mass index in kg/m2 (BMI)
Measured: 180 days
To evaluate the metabolic effects of testosterone implants on waist circumference.
To evaluate the metabolic effects of testosterone implants on the measure of waist circumference in centimeters (cm).
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Male HypogonadismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Implant of four BIOS testosterone pellets of 200mg in hypogonadal man and followup with pharmacokinetics of the response
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristiano Mendes Gomes, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500766
- Sponsor's protocol ID
- 88009225.0.0000.0068
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23859250McMahon 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.
PubMed 28673432Kaminetsky 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.
PubMed 21269402Cavender 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.
PubMed 19796052Kresch 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.
PubMed 36936900McCullough 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.
PubMed 25999802