Recovery of Gonadal Function by Clomiphene in Males With Prolactinomas and Persistent Hypogonadism
Phase 2
18 Years
70 Years
18 Years
70 Years
Not Enrolling
Male
Hypogonadotropic Hypogonadism, Prolactinoma
Male
Hypogonadotropic Hypogonadism, Prolactinoma
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
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