Skip to main content
OpenTrials
Completed

NCT Number: NCT00697814

Clomiphene in Males With Prolactinomas and Persistent Hypogonadism

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypogonadotropic Hypogonadism Adenoma Brain Diseases Central Nervous System Diseases Endocrine Gland Neoplasms Endocrine System Diseases Gonadal Disorders Hypogonadism Hypothalamic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nervous System Diseases Pituitary Diseases Pituitary Neoplasms Prolactinoma

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Neuroendocrine Unit - Escola Paulista de Medicina (UNIFESP)

São Paulo, 09541-330, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clomiphene Citrate

Drug

Clomiphene 50 mg/day for 12 weeks

Primary outcomes

  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 outcomes

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

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jun 16, 2008
Registry last updated
Jun 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.