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...
Date First Received: June 12, 2008
Last Updated: June 13, 2008
Verified by: Federal University of São Paulo, June 2008
Clinical Trial Phase: Phase 2 | Start Date: June 2004
Overall Status: Completed
Estimated Enrollment: 15
Brief Summary
Official Title: “Recovery of Gonadal Function by Clomiphene in Males With Prolactinomas and Persistent Hypogonadism”
Condition Keyword(s):
Intervention(s):
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
Outcome Measures for this Clinical Trial
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
- Time Frame: 10 days, 4, 8 and 12 weeks
Secondary Measures
- Assess the effects of CC on sexual function, fertility, body composition, lipid and glucose metabolism, and quality of life were also evaluated.
Criteria for Participation in this Clinical Trial
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
Clinical Trial Sponsor Information
Lead Sponsor: Federal University of São Paulo
Overall Clinical Trial Officials and Contacts
Julio Abucham, MD, PhD Study Chair Neuroendocrine Unit
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
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
Clinical Trials Authorship and Review
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