Clomiphene in Males With Prolactinomas and Persistent Hypogonadism

Federal University of São Paulo15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Enrollment

Conditions

Hypogonadotropic Hypogonadism Prolactinoma

Interventions

Clomiphene citrateDRUG

Clomiphene 50 mg/day for 12 weeks

Eligibility

Sex: MALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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 (1)

Neuroendocrine Unit - Escola Paulista de Medicina (UNIFESP)

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

assess the effects of CC treatment on testosterone levels in male patients with prolactinomas and persistent HH on dopaminergic agonist therapy

Time frame: 10 days, 4, 8 and 12 weeks

Secondary Outcomes

Assess the effects of CC on sexual function, fertility, body composition, lipid and glucose metabolism, and quality of life were also evaluated.

Data from ClinicalTrials.gov

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