Trial Information
Recovery of Gonadal Function by Clomiphene in Males With Prolactinomas and Persistent Hypogonadism
Inclusion Criteria:
- a minimum follow-up of 6 months under DA therapy with normal serum prolactin or with
maximum DA dose (3.5 mg/week of cabergoline or 10 mg/day of bromocriptine for at
least 2 months)
- serum total testosterone less than 300ng/dl with normal or low LH and FSH levels
after discontinuing testosterone replacement for at least 2 months.
Exclusion Criteria:
- impossibility to attend scheduled visits and irregular compliance to DA treatment.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment
Outcome Measure:
assess the effects of CC treatment on testosterone levels in male patients with prolactinomas and persistent HH on dopaminergic agonist therapy
Outcome Time Frame:
10 days, 4, 8 and 12 weeks
Safety Issue:
No
Principal Investigator
Julio Abucham, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Neuroendocrine Unit
Authority:
Brazil: National Committee of Ethics in Research
Study ID:
1374/04
NCT ID:
NCT00697814
Start Date:
June 2004
Completion Date:
June 2005
Related Keywords:
- Hypogonadotropic Hypogonadism
- Prolactinoma
- Hypogonadotropic hypogonadism
- Prolactinoma
- Hypogonadism
- Prolactinoma