Men with hypogonadotropic hypogonadism treated with testosterone substitution
Conditions
Interventions
Trade Name: Femara
Product Name: Femara
Product Code: RVG 20755
Pharmaceutical Form: Tablet
INN or Proposed INN: LETROZOLE
CAS Number: 112809515
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Rijnstate hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Male 2) Age 20 - 70 years 3) Hypogonadotropic hypogonadism (serum testosterone 1 month 5) Adequate treatment for pituitary insufficiency other than LH deficiency 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Untreated pituitary tumor 2) Disease of the liver (> 2 times upper level of normal) 3) Disease of Kidney (serum creatinine > 150 µmol/L) 4) Cancer 5) Benign or malignant disease of prostate 6) Osteoporosis: T-score bonedensity (lumbal spine or hip) < -2.5 SD 7) Medication which can influence the metabolism of Andriol or Letrozol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Is adding Letrozol to hypogonadotropic hypogonaal men, treated with Andriol, leading to an increase in serum testosterone levels? And if effective, how much is the increase? ;Secondary Objective: Is adding Letrozol to men treated with Andriol, leading to a decrease of serum estrogen levels? Are fysiological levels reached? ;Primary end point(s): -Testosterone levels (8 hourly taken for 24 hours) and after using letrozol in patients treated with testosterone replacement. -Estrogen levels (8 hourly taken for 24 hours) before and after using letrozol in patients treated with testosterone replacement. -LH and FSH before and after using letrozol. | — |
Countries
Netherlands
Outcome results
None listed