F32 E29
Conditions
Interventions
Group 1: injection of 1000 mg testosteroneundecanoate (Nebido)
0, 6, 18, 30 weeks after beginning of treatment
Group 2: injection of 4 ml Placebo
0, 6, 18, 30 weeks after beginning of treatment
Sponsors
Marin-Luther-Universität Halle-Wittenberg
Eligibility
Sex/Gender
Male
Age
60 Years to No maximum
Inclusion criteria
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 = 13 (within last week)
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| score geriatric depression scale (GDS-30) 42 weeks after beginning of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| score of questionnaires (time after beginning of treatment): 1)Geriatric Depression scale (GDS-30), (week -2, week 18, week 42) 2) Ageing Male's Symptom Scale (AMS) (week -2, week 18, week 42) 3) Depression scale of PHQ-D (PHQ-9) (week -2, week 18, week 42) 4) IIEF (International Inventory of erectile function) (week -2, week 18, week 42) 5) BDI-II (Beck Depressions Inventory) (week -2, week 6, week 18, week 30, week 42) 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) | — |
Countries
Germany
Contacts
Public ContactHermann Behre
Zentrum für Reproduktionsmedizin und Andrologie der Universität Halle-Wittenberg
Outcome results
None listed