Phase 2
Completed N=16
Clomiphene Citrate for Treatment of Acromegaly
Acromegaly
Source: ClinicalTrials.gov NCT02274311 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: IGF-1 Levels — 424 ng/mL — p=< 0.05
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)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY IGF-1 Levels |
424 | < 0.05 sig |
| SECONDARY Testosterone Levels |
282 | — |
| SECONDARY PSA Levels |
2.0 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02274311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.