Clinical Trial: Clomiphene Citrate for Treatment of Acromegaly

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Clomiphene Citrate for Treatment of Acromegaly Not Controlled by Conventional Therapies

Brief Summary: To assess the impact of clomiphene citrate on serum insulin like growth factor 1 and testosterone levels in male acromegalic patients not controlled by surgery, radiotherapy and/or medical treatments (somatostatin analogues, dopamine agonists and/or growth hormone receptor antagonist)

Detailed Summary:

Acromegaly, a disease caused by a growth hormone secreting pituitary adenoma, results in reduced life span. Despite the many modalities available to treat this disease,as surgery, medical treatment and radiotherapy, uncontrolled disease persists in a significant portion of patients

Oral estrogens, alone or in combination with somatostatin receptor analogues, have been shown to control acromegaly in women. Selective estrogen receptor modulators (SERMs) resulted in similar effects in both genders. Clomiphene citrate, a SERM that increases luteinizing hormone and follicle stimulating hormone secretion, improves hypogonadism and fertility outcomes.

The aim of this study is to assess the impact of clomiphene citrate on serum insulin like growth factor 1 and testosterone levels in male acromegalic patients not controlled by surgery, radiotherapy and/or medical treatment.

In this prospective, open label, single center trial, sixteen male patients were studied. Clomiphene citrate (50 mg/day) was added to previous medical treatment for 3 months and hormonal assessment was performed prior to and during the intervention. Hormones included: growth hormone, insulin like growth factor, total testosterone, follicle stimulating hormone, luteinizing hormone and prostate-specific antigen.


Sponsor: Felipe Henning Gaia Duarte

Current Primary Outcome: IGF-1 levels [ Time Frame: Three months ]

The objective is to compare the change of IGF-1 value assessed in the beginning of the study (day 0), with the value obtained after three months of use of clomiphene citrate (day 90).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Testosterone levels [ Time Frame: Three months ]
    The objective is to compare the change of testosterone value assessed in the beginning of the study (day 0), with the value obtained after three months of use of clomiphene citrate (day 90).
  • PSA levels [ Time Frame: Three months ]
    The objective is to compare the change of PSA value assessed in the beginning of the study (day 0), with the value obtained after three months of use of clomiphene citrate (day 90).


Original Secondary Outcome: Same as current

Information By: University of Sao Paulo General Hospital

Dates:
Date Received: October 20, 2014
Date Started: January 2011
Date Completion:
Last Updated: October 23, 2014
Last Verified: October 2014