Clomiphene in Males With Prolactinomas and Persistent Hypogonadism

Hypogonadotropic Hypogonadism Clinical Trial

Official title:

Recovery of Gonadal Function by Clomiphene in Males With Prolactinomas and Persistent Hypogonadism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697814
• Other study ID #: 1374/04
• Status: Completed
• Phase: Phase 2
• First received: June 12, 2008
• Last updated: June 13, 2008
• Start date: June 2004
• Est. completion date: June 2005

Study information

• Verified date: June 2008
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in ResearchBrazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism
• Hypogonadotropic Hypogonadism
• Prolactinoma

Intervention

Drug:
• Clomiphene citrate
Clomiphene 50 mg/day for 12 weeks

Locations

Country	Name	City	State
Brazil	Neuroendocrine Unit - Escola Paulista de Medicina (UNIFESP)	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assess the effects of CC treatment on testosterone levels in male patients with prolactinomas and persistent HH on dopaminergic agonist therapy		10 days, 4, 8 and 12 weeks	No
Secondary	Assess the effects of CC on sexual function, fertility, body composition, lipid and glucose metabolism, and quality of life were also evaluated.