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Clomiphene in Males With Prolactinomas and Persistent Hypogonadism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00697814
Recruitment Status : Completed
First Posted : June 16, 2008
Last Update Posted : June 16, 2008
Information provided by:
Federal University of São Paulo

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.

Condition or disease Intervention/treatment Phase
Hypogonadotropic Hypogonadism Prolactinoma Drug: Clomiphene citrate Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: Recovery of Gonadal Function by Clomiphene in Males With Prolactinomas and Persistent Hypogonadism
Study Start Date : June 2004
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Clomiphene
Clomiphene 50 mg/day for 12 weeks
Drug: Clomiphene citrate
Clomiphene 50 mg/day for 12 weeks

Primary Outcome Measures :
  1. 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 ]

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

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00697814

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Neuroendocrine Unit - Escola Paulista de Medicina (UNIFESP)
Sao Paulo, SP, Brazil, 09541-330
Sponsors and Collaborators
Federal University of São Paulo
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Study Chair: Julio Abucham, MD, PhD Neuroendocrine Unit

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Responsible Party: Julio Abucham, Neuroendocrine Unit Identifier: NCT00697814     History of Changes
Other Study ID Numbers: 1374/04
First Posted: June 16, 2008    Key Record Dates
Last Update Posted: June 16, 2008
Last Verified: June 2008
Keywords provided by Federal University of São Paulo:
Hypogonadotropic hypogonadism
Additional relevant MeSH terms:
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Gonadal Disorders
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pituitary Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators