Clomiphene in Males With Prolactinomas and Persistent Hypogonadism - Full Text View

Sponsor:	Federal University of São Paulo
Information provided by:	Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT00697814

Purpose

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.

Condition	Intervention	Phase
Hypogonadotropic Hypogonadism Prolactinoma	Drug: Clomiphene citrate	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Recovery of Gonadal Function by Clomiphene in Males With Prolactinomas and Persistent Hypogonadism

Resource links provided by NLM:

Drug Information available for: Clomiphene citrate Zuclomiphene Enclomiphene Clomiphene trans-Clomifene citrate

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Enrollment:	15
Study Start Date:	June 2004
Study Completion Date:	June 2005
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Clomiphene: Experimental Clomiphene 50 mg/day for 12 weeks	Drug: Clomiphene citrate Clomiphene 50 mg/day for 12 weeks

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697814

Locations

Brazil, SP
Neuroendocrine Unit - Escola Paulista de Medicina (UNIFESP)
Sao Paulo, SP, Brazil, 09541-330

Sponsors and Collaborators

Federal University of São Paulo

Investigators

Study Chair:

Julio Abucham, MD, PhD

Neuroendocrine Unit

More Information

No publications provided

Responsible Party:	Neuroendocrine Unit ( Julio Abucham )
Study ID Numbers:	1374/04
Study First Received:	June 12, 2008
Last Updated:	June 13, 2008
ClinicalTrials.gov Identifier:	NCT00697814 History of Changes
Health Authority:	Brazil: National Committee of Ethics in Research; Brazil: Ministry of Health

Keywords provided by Federal University of São Paulo:

Hypogonadotropic hypogonadism
Prolactinoma

Additional relevant MeSH terms:

Gonadal Disorders
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Clomiphene
Reproductive Control Agents
Pituitary Neoplasms
Selective Estrogen Receptor Modulators
Brain Diseases
Estrogen Receptor Modulators
Neoplasms by Site
Therapeutic Uses
Endocrine Gland Neoplasms
Hypothalamic Diseases

Estrogen Antagonists
Neoplasms by Histologic Type
Pituitary Diseases
Nervous System Diseases
Endocrine System Diseases
Central Nervous System Diseases
Prolactinoma
Pharmacologic Actions
Neoplasms
Hypogonadism
Fertility Agents, Female
Fertility Agents
Adenoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 09, 2009