Clomiphene in Males With Prolactinomas and Persistent Hypogonadism

Federal University of São Paulo

Status and phase: Completed; Phase 2

Conditions: Hypogonadotropic Hypogonadism; Prolactinoma

Treatments: Drug: Clomiphene citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT00697814

1374/04

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

15 participants in 1 patient group

Clomiphene

Experimental group

Description:

Clomiphene 50 mg/day for 12 weeks

Treatment:

Drug: Clomiphene citrate