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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00697814
Other study ID # 1374/04
Secondary ID
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


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.
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