Effect of treatment with testosterone in diabetic patients (Type 1) with hypogonadism.

Effect of treatment with testosterone undecaonat in patients with Diabetes Mellitus Type 1 (DM-1) and hipogonadotrophic hypogonadism

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000291-42-ES

Enrollment

Unknown

Registered

2012-08-23

Start date

2012-10-05

Completion date

Unknown

Last updated

2017-04-03

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

Conditions

Diabetes Mellitus Type 1 (DM-1) and hipogonadotrophic hypogonadism

Interventions

Trade Name: REANDRON Product Name: Testosterone undecaonat Product Code: Reandron Pharmaceutical Form: Solution for injection INN or Proposed INN: TESTOSTERONE CAS Number: 58-22-0 Concentration unit:

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Men older than or equal to 18. 2. Submit a diagnosis of diabetes mellitus type 1 and hypogonadotropic hypogonadism, defined as: ? Levels of total testosterone =65 years) yes F.1.3.1 Number of subjects for this age range 14

Exclusion criteria

Exclusion criteria: 1. Existence of chronic debilitating disease such as kidney failure, cirrhosis, HIV, COPD, heart failure, ischemic heart disease. 2. Patients with hypergonadotropic hypogonadism. 3. Patients diagnosed with panhypopituitarism. 4. Patients with hypogonadotropic hypogonadism secondary to pituitary tumor or empty sella. 5. Patients with hypogonadotropic hypogonadism secondary to hyperprolactinemia. 6. Patients with contraindications to the administration of testosterone: elevated PSA, breast carcinoma, prostate carcinoma, liver tumors 7. Patients previously treated with testosterona 8. Patients with allergy to testosterone and/or excipients.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Analyze changes in the international index of erectile dysfunction after 22 weeks of treatment with testosterone undecanoate in patients with DM1 and hypogonadotropic hypogonadism.;Primary end point(s): Changing values of eGDR after 6, 16 and 22 weeks of treatment with testosterone undecanoate / placebo.;Timepoint(s) of evaluation of this end point: 22 weeks;Main Objective: Evaluate the effectiveness of testosterone replacement therapy in patients with DM1 and hypogonadotropic hypogonadism on insulin sensitivity, measured by eGDR (estimated Glucose Disposal Rate) and evaluate the effectiveness of testosterone replacement therapy in patients with DM1 and hypogonadotropic hypogonadism on the control anthropometric parameters glycemic blood pressure and lipid profile.	—

Measure

Time frame

Secondary Objective: Analyze changes in the international index of erectile dysfunction after 22 weeks of treatment with testosterone undecanoate in patients with DM1 and hypogonadotropic hypogonadism.;Primary end point(s): Changing values of eGDR after 6, 16 and 22 weeks of treatment with testosterone undecanoate / placebo.;Timepoint(s) of evaluation of this end point: 22 weeks;Main Objective: Evaluate the effectiveness of testosterone replacement therapy in patients with DM1 and hypogonadotropic hypogonadism on insulin sensitivity, measured by eGDR (estimated Glucose Disposal Rate) and evaluate the effectiveness of testosterone replacement therapy in patients with DM1 and hypogonadotropic hypogonadism on the control anthropometric parameters glycemic blood pressure and lipid profile.

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Secondary

Measure	Time frame
Secondary end point(s): Changes in glycemic control (HbA1c and FPG), anthropometric parameters (BMI, hip circumference, waist circumference), blood pressure and lipid profile. Score on the questionnaire of erectile dysfunction.;Timepoint(s) of evaluation of this end point: 22 weeks	—

Countries

Spain

Contacts

Public ContactServicio de Endocrinología

Hospital del Mar

JChillaron@parcdesalutmar.cat0034932483902

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026