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Clomiphene Citrate for Treatment of Acromegaly

Information source: University of Sao Paulo General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acromegaly

Intervention: Clomiphene Citrate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Felipe Henning Gaia Duarte

Official(s) and/or principal investigator(s):
Marcello D Bronstein, MD, PhD, Study Chair, Affiliation: Unit of Neuroendocrinology, Discipline of Endocrinology, Department of Internal Medicine Clinical Hospital of the University of São Paulo Medical School, São Paulo, Brazil

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)

Clinical Details

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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: IGF-1 levels

Secondary outcome:

Testosterone levels

PSA levels

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- patients with active acromegaly on regular use of a stable dose of Octreotide-LAR

and/or cabergoline for at least one year,

- Insulin like growth factor 1 above the reference range during the last year of

follow-up and

- testosterone levels within or below the third inferior tertile of normality.

Exclusion Criteria:

- radiotherapy in the last 10 years, previous venous embolism (including family

members),

- previous prostatic cancer or symptomatic benign hypertrophy,

- triglyceride levels above 400 mg/dL,

- renal failure defined by estimative of renal filtration below 30 ml/min,

- liver disease defined by hepatic enzymes 3 times above normal limit,

- active oncologic disease in the last 10 years and previous cardiac or cerebrovascular

disease.

Locations and Contacts

Additional Information

Starting date: January 2011
Last updated: October 23, 2014

Page last updated: August 23, 2015

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