Clomiphene Citrate for Treatment of Acromegaly

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: Male

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Felipe Henning Gaia Duarte
• Treatments: Citric Acid; Clomiphene; Enclomiphene; Zuclomiphene

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.