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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00697814 |
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Date of registration:
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12/06/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clomiphene in Males With Prolactinomas and Persistent Hypogonadism
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Scientific title:
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Recovery of Gonadal Function by Clomiphene in Males With Prolactinomas and Persistent Hypogonadism |
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Date of first enrolment:
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June 2004 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00697814 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Julio Abucham, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Neuroendocrine Unit |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Hypogonadotropic Hypogonadism
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Prolactinoma
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Intervention(s)
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Drug: Clomiphene citrate
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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