Clomiphene in Males With Prolactinomas and Persistent Hypogonadism - Tabular View

Tracking Information

First Received Date ^ICMJE

June 12, 2008

Last Updated Date

June 13, 2008

Start Date ^ICMJE

June 2004

Primary Completion Date

June 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00697814 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Clomiphene in Males With Prolactinomas and Persistent Hypogonadism

Official Title ^ICMJE

Recovery of Gonadal Function by Clomiphene in Males With Prolactinomas and Persistent Hypogonadism

Brief 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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Hypogonadotropic Hypogonadism
Prolactinoma

Intervention ^ICMJE

Drug: Clomiphene citrate

Study Arms / Comparison Groups

Experimental: Clomiphene 50 mg/day for 12 weeks

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2005

Primary Completion Date

June 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Male

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT ID ^ICMJE

NCT00697814

Responsible Party

Julio Abucham, Neuroendocrine Unit

Study ID Numbers ^ICMJE

1374/04

Study Sponsor ^ICMJE

Federal University of São Paulo

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Julio Abucham, MD, PhD

Neuroendocrine Unit

Information Provided By

Federal University of São Paulo

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP