etrozole Treatment to Normalize Serum Testosterone in Men with Hypogonadotropic Hypogonadism due to Pituitary Damage.

• Conditions: Hypogonadotropic hypogonadism in men with pituitary damage other than irradiation; MedDRA version: 8.1Level: LLTClassification code 10021012Term: Hypogonadotrophic hypogonadism

• Registration Number: EUCTR2006-002304-33-NL
• Lead Sponsor: Rijnstate Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

-Male
-Age: 18-50 years
-Hypogonadotropic hypogonadism: serum total testosterone 2-10 nmol/L and calculated serum free testosterone < 225 pmol/L and serum LH < 9 U/L
-Pituitary damage on MRI: (hormonally inactive) pituitary adenoma or partial empty sella
-Residual LH and FSH secretion, as indicated bij the presence of detectable serum LH and FSH levels in the basal state, i.e. levels > 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

-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 < -2.5 sd
-Renal failure:serum creatinin > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>-To determine whether Letrozole normalizes diurnal rhythm of LH and testosterone secretion. <br>-To determine whether Letrozole stimulates FSH production and thereby increases semen quantity<br>-To determine the side effects of long term Letrozole treatment