Back to resultsClomiphene in Males With Prolactinomas and Persistent Hypogonadism
Primary Purpose
Hypogonadotropic Hypogonadism, Prolactinoma
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Clomiphene citrate
Sponsored by
About this trial
This is an interventional treatment trial for Hypogonadotropic Hypogonadism focused on measuring Hypogonadotropic hypogonadism, Prolactinoma
Eligibility 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.
Sites / Locations
- Neuroendocrine Unit - Escola Paulista de Medicina (UNIFESP)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Clomiphene
Arm Description
Clomiphene 50 mg/day for 12 weeks
Outcomes
Primary Outcome Measures
assess the effects of CC treatment on testosterone levels in male patients with prolactinomas and persistent HH on dopaminergic agonist therapy
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.
Full Information
NCT ID
NCT00697814
First Posted
June 12, 2008
Last Updated
June 13, 2008
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00697814
Brief Title
Clomiphene in Males With Prolactinomas and Persistent Hypogonadism
Official Title
Recovery of Gonadal Function by Clomiphene in Males With Prolactinomas and Persistent Hypogonadism
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadotropic Hypogonadism, Prolactinoma
Keywords
Hypogonadotropic hypogonadism, Prolactinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clomiphene
Arm Type
Experimental
Arm Description
Clomiphene 50 mg/day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Clomiphene citrate
Intervention Description
Clomiphene 50 mg/day for 12 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Assess the effects of CC on sexual function, fertility, body composition, lipid and glucose metabolism, and quality of life were also evaluated.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julio Abucham, MD, PhD
Organizational Affiliation
Neuroendocrine Unit
Official's Role
Study Chair
Facility Information:
Facility Name
Neuroendocrine Unit - Escola Paulista de Medicina (UNIFESP)
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
09541-330
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Clomiphene in Males With Prolactinomas and Persistent Hypogonadism
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