ate-onset hypogonadism (LOH) and depressive mood changes - a double blind, placebo-controlled study with intramuscular application of testosterone undecanoate

Phase 4

• Conditions: F32; E29; Depressive episode; Testicular dysfunction

• Registration Number: DRKS00005485
• Lead Sponsor: Marin-Luther-Universität Halle-Wittenberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-07
• Study Completion: 2015-12-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: Male
• Target Recruitment: 1

Inclusion Criteria

written informed consent; men with age at least 60 years; confirmed late-onset hypogonadism (according to International Society of Andrology 2009); confirmed depressive mood (ICD10 F32.0 - F32.1); either total testosterone level < 12 nmol/l or free testosterone < 225 pmol/l; score GDS-30 >= 13 (within last week)

Exclusion Criteria

taking of Androgens or Anabolics within last 12 months; PSA = 4 ng/ml; pathological finding of prostate (DRE); diagnose or suspicion of tumor of prostate, mamma and liver; Major Depression (ICD10 F32.2 - F32.3); known dementia;known abuse of alcohol and drugs;
other known psychiatric disease (psychiatric examination) or psychotherapy; BDI-II >=20, item 9 BDI-II (suicidality) >=1); acute or life-threatening disease (estimated expectancy of life < 2 years); chronic disease, possibly affecting security of patient during study (e.g. Haemochromatosis, Dubin-Johnson-Rotor-Syndrome, chronic disease of lung;
Hypersensitivity against IMP or substances of IMP; problems of coagulation with increased risk of bleeding after injection; sleep apnea; Polycythaemia; Haematocrit > 50 %; taking of 5a-Reductase-Inhibitors; Prolactin > 25 ng/ml; benign hyperplasia of prostate with obstruction of bladder neck (residual urine > 200 ml); BMI > 35 kg/m²; untreated dysfunction of thyroid gland; untreated Diabetes mellitus (HbA1C > 9%); untreated Epilepsy; untreated Migaine; planned or actual therapy for reproduction; psychiatric or other disease to hinder the patient to understand content of study; unsufficient treatment of hypertension; known insufficiency of heart, liver and kidney; unsufficient treatment of coronary heart disease; known or actual thrombotic event; participation on other clinical trials; taking of Androgens, Anabolics, Clomipramin, Antiandrogens, Estrogens; Corticotropinen (ACTH); Oxyphenbutazon; psychotropic drugs

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
score geriatric depression scale (GDS-30) 42 weeks after beginning of treatment

Secondary Outcome Measures

Name	Time	Method
score of questionnaires (time after beginning of treatment):<br>1)Geriatric Depression scale (GDS-30), (week -2, week 18, week 42)<br>2) Ageing Male's Symptom Scale (AMS) (week -2, week 18, week 42)<br>3) Depression scale of PHQ-D (PHQ-9) (week -2, week 18, week 42)<br>4) IIEF (International Inventory of erectile function) (week -2, week 18, week 42)<br>5) BDI-II (Beck Depressions Inventory) (week -2, week 6, week 18, week 30, week 42)<br>6) time until psychiatric council is necessary (Score of BDI-II >= 20 and/or item 9 BDI-II (suicidality) >=1) (week -2, week 6, week 18, week 30, week 42)