Hypogonadotropic hypogonadism in men with pituitary damage other than irradiation MedDRA version: 8.1 Level: LLT Classification code 10021012 Term: Hypogonadotrophic hypogonadism
Conditions
Interventions
Trade Name: Femara
Product Name: Femara
Product Code: RVG 20755
Pharmaceutical Form: Tablet
INN or Proposed INN: LETROZOLE
CAS Number: 112809515
Current Sponsor code: RVG 20755
Concentration unit: mg
Sponsors
Rijnstate Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: -Male -Age: 18-50 years -Hypogonadotropic hypogonadism: serum total testosterone 2-10 nmol/L and calculated serum free testosterone 1 U/L ( after 4 weeks withdrawal of testosterone replacement therapy) -Testicular length on palpation > 1 cm -Adequate and stable replacement therapy for pituitary hormone deficiencies other than LH and FSH 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Pituitary irradiation -Untreated pituitary adenoma associated with compression of the optic chiasm -Benign or malignant diseases of the prostate -Osteoporosis: T-score Lumbal Spine of hip 150 micromol/L -Liver disease: liver enzymes > 2 times the upper normal limit -Unstable chronic illness -Any mental disturbance -Non-endocrine medication known to affect Letrozole availability or bone metabolism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether hypogonadotropic hypogonadism in patients with pituitary disease is reversible with Letrozole. To determine the minimal effective dose to normalize serum testosterone. To determine whether Letrozole normalizes diurnal rhythm of LH and testosterone secretion. To determine whether Letrozole stimulates FSH production and thereby increases semen quantity. To determine the effects of long term Letrozole treatment on bone mass and metabolism.;Secondary Objective: To study the effects on bone metabolism.;Primary end point(s): -The minimal effective dose to normalize serum testosterone. -To determine whether Letrozole normalizes diurnal rhythm of LH and testosterone secretion. -To determine whether Letrozole stimulates FSH production and thereby increases semen quantity -To determine the side effects of long term Letrozole treatment | — |
Countries
Netherlands
Outcome results
None listed