EUCTR2012-000291-42-ES
Active, not recruiting
Phase 1
Effect of treatment with testosterone undecaonat in patients with Diabetes Mellitus Type 1 (DM-1) and hipogonadotrophic hypogonadism
DrugsREANDRON
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Consorci Mar Parc de Salut de Barcelona (Parc de Salut Mar)
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \<8nmol / L(2\.3 ng/mL), or total testosterone levels between 8 and 12 nmol / L (2\.3\-3\.5 ng/mL)and calculated free testosterone \<225 pmol / L (65 pg / mL).
- •? Determination of LH below 8\.6 mU / mL and / or FSH lower than 14\.2 IU / L.
- •3\. Being able to provide informed consent before randomization and agree to abide by the study protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 14
- •F.1\.3 Elderly (\>\=65 years) yes
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.
Outcomes
Primary Outcomes
Not specified
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