Clomiphene in Males With Prolactinomas and Persistent Hypogonadism
Information source: Federal University of São Paulo
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypogonadotropic Hypogonadism; Prolactinoma
Intervention: Clomiphene citrate (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Federal University of São Paulo Official(s) and/or principal investigator(s):
Julio Abucham, MD, PhD, Study Chair, Affiliation: Neuroendocrine Unit
Summary
Prolactinomas are usually associated with hypogonadotropic hypogonadism in both sexes.
Clomiphene citrate is a well known selective estrogen receptor modulator that increases
gonadotropin secretion via hypothalamic-pituitary action. We conducted a prospective, open
label clinical trial of CC to evaluate its effects in reverting persistent HH in male
patients with prolactinomas under dopaminergic agonist treatment.
Clinical Details
Official title: Recovery of Gonadal Function by Clomiphene in Males With Prolactinomas and Persistent Hypogonadism
Study design: Treatment, Non-Randomized, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: assess the effects of CC treatment on testosterone levels in male patients with prolactinomas and persistent HH on dopaminergic agonist therapy
Secondary outcome: Assess the effects of CC on sexual function, fertility, body composition, lipid and glucose metabolism, and quality of life were also evaluated.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Male.
Criteria:
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.
Locations and Contacts
Neuroendocrine Unit - Escola Paulista de Medicina (UNIFESP), Sao Paulo, SP 09541-330, Brazil
Additional Information
Starting date: June 2004
Ending date: June 2005
Last updated: June 13, 2008
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