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Clomiphene in Males With Prolactinomas and Persistent Hypogonadism

NCT ID: NCT00697814

Last Updated: 2008-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2005-06-30

Brief Summary

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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

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Conditions

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Hypogonadotropic Hypogonadism Prolactinoma

Keywords

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Hypogonadotropic hypogonadism Prolactinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Study Groups

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Clomiphene

Clomiphene 50 mg/day for 12 weeks

Group Type EXPERIMENTAL

Clomiphene citrate

Intervention Type DRUG

Clomiphene 50 mg/day for 12 weeks

Interventions

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Clomiphene citrate

Clomiphene 50 mg/day for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Neuroendocrine Unit

Principal Investigators

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Julio Abucham, MD, PhD

Role: STUDY_CHAIR

Neuroendocrine Unit

Locations

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Neuroendocrine Unit - Escola Paulista de Medicina (UNIFESP)

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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1374/04

Identifier Type: -

Identifier Source: org_study_id