A Phase 2 interventional study of Subcutaneous Testosterone Implants in Male Hypogonadism, Testosterone Deficiency and Testosterone Replacement Therapy, sponsored by University of Sao Paulo. Not yet recruiting. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by University of Sao Paulo · Phase 2, Interventional, and Treatment
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).
75 studies on the registry are indexed under Eunuchism; 21 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 55 interventional studies indexed under Eunuchism.
Browse Eunuchism studies →University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subcutaneous Testosterone Implants in Men With Symptomatic Hypogonadism
Drug: Subcutaneous Testosterone Implants
Subcutaneous Testosterone Implants in Men With Symptomatic Hypogonadism
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
Time frame: 180 days
Maximum Plasma Testosterone Concentration
Assessment of the maximum plasma concentration of total testosterone.
Time frame: 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.
Time frame: Up to 180 days
Plasma Testosterone Elimination Half-Life (T½)
Assessment of the elimination half-life of total testosterone in plasma following implantation.
Time frame: Up to 180 days
Average Plasma Testosterone Concentration (Cavg)
Assessment of the average plasma concentration of total testosterone following implantation.
Time frame: Up to 180 days
Area Under the Plasma Concentration-Time Curve
Assessment of the area under the curve of plasma concentration.
Time frame: Up to 180 days
To evaluate the safety profile of testosterone implants.
Evaluate the incidence of complications in a clavien dindo scale
Time frame: 180 days
Change in Serum Luteinizing Hormone (LH) Levels
Assessment of changes in serum luteinizing hormone (LH) levels during treatment with testosterone implants.
Time frame: Up to 180 days
Evaluation of sexual outcomes
To evaluate the incidence of erectile dysfunction withe the International Index of Erectile Function.
Time frame: 180 days
Evaluation of coagulation after testosterone implants
Evaluate the plasma thromboelastography in men treated with testosterone implants.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 180 days
To assess patient satisfaction with testosterone implant therapy.
To assess patient satisfaction with a numerical Likert scale 1 to 5
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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).
Time frame: 180 days
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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