Status:
COMPLETED
Clomiphene Citrate for Treatment of Acromegaly
Lead Sponsor:
Felipe Henning Gaia Duarte
Conditions:
Acromegaly
Eligibility:
MALE
18-80 years
Phase:
PHASE2
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 ...
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 an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02274311
Start Date
January 1 2011
End Date
October 1 2014
Last Update
May 7 2019
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