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Effect of testosterone replacement in hypogonadal men with overweight and obesity: a clinical trial

Effect of testosterone replacement associated with diet and physical activity in hypogonadal men with overweight and obesity: a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-67bq38w
Enrollment
Unknown
Registered
2025-10-15
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Interventions

This is a randomized, not blinded, controlled clinical trial with two parallel groups. A total of 36 men with hypogonadism, overweight, or obesity, defined by a body mass index between 25 and 35 kilog

Sponsors

Hospital e Maternidade São Domingos
Lead Sponsor
Hospital e Maternidade São Domingos
Collaborator

Eligibility

Sex/Gender
Male
Age
30 Years to 60 Years

Inclusion criteria

Inclusion criteria: Obese or overweight men (Body Mass Index above 25 and less than 35; between 30 and 60 years of age; with low testosterone levels (less than 350 nanograms per deciliter); with symptoms of hypogonadism

Exclusion criteria

Exclusion criteria: Individuals interested in fertility in the 6 months following therapy; presence of Diabetes Mellitus; presence of hypertension; presence of Nephropathy; presence of heart disease; presence of Hepatopathy; presence of Depression; presence of anxiety disorders; presence of other hormonal diseases; presence of Hypogonadism of primary cause (testicular failure); diagnosis of active prostate or breast cancer; previous diagnosis of breast cancer; severe urinary symptoms through the score; International Prostate Symptom Score greater than 19; severe cardiopulmonary disease such as unstable angina and recent myocardial infarction; personal or family history of Thromboembolism; hematocrit above 48 percent; patients with implanted medical devices (pacemakers) or essential support devices such as monitors

Design outcomes

Primary

MeasureTime frame
A significant impact of testosterone replacement therapy on weight loss and muscle mass is expected

Secondary

MeasureTime frame
A significant impact of testosterone replacement therapy on quality of life and sexual health scores is expected;A significant impact of testosterone replacement therapy on metabolic and inflammatory parameters is expected

Countries

Brazil

Contacts

Public ContactRodrigo Diniz

Universidade Federal do Maranhão

rodrigo.urologia@hotmail.com+55 (98) 98113-2969

Outcome results

None listed

Source: REBEC (via WHO ICTRP)