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 levelsPSA 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
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