Official Title: “Recovery of Gonadal Function by Clomiphene in Males With Prolactinomas and Persistent Hypogonadism”

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

Study Design: Treatment, Non-Randomized, Uncontrolled, Single Group Assignment, Efficacy Study

Study Primary Completion Date: June 2005

Intervention(s) in this Clinical Trial

• Drug: Clomiphene citrate
  • Clomiphene 50 mg/day for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Clomiphene
  • Clomiphene 50 mg/day for 12 weeks

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

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

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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Federal University of São Paulo

Overall Clinical Trial Officials and Contacts

Julio Abucham, MD, PhD Study Chair Neuroendocrine Unit  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00697814

Study ID Number: 1374/04

ClinicalTrials.gov Identifier: NCT00697814

Health Authority: Brazil: National Committee of Ethics in Research