Clomiphene Citrate for Treatment of Acromegaly
1 other identifier
interventional
16
0 countries
N/A
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 (somatostatin analogues, dopamine agonists and/or growth hormone receptor antagonist)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2011
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 20, 2014
CompletedFirst Posted
Study publicly available on registry
October 24, 2014
CompletedResults Posted
Study results publicly available
May 7, 2019
CompletedMay 7, 2019
April 1, 2019
3.8 years
October 20, 2014
December 1, 2015
April 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IGF-1 Levels
The objective is to compare the change of IGF-1 value assessed in the beginning of the study (day 0), with the value obtained after three months of use of clomiphene citrate (day 90).
Day 90
Secondary Outcomes (2)
Testosterone Levels
D90
PSA Levels
Day 90
Study Arms (1)
Clomiphene citrate
EXPERIMENTALPatients receiving clomiphene citrate
Interventions
Clomiphene citrate, 50 mg, orally for three months
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Felipe Henning Gaia Duarte
- Organization
- Hospital das Clinicas da Faculdade de Medicina da USP
Study Officials
- STUDY CHAIR
Marcello D Bronstein, MD, PhD
Unit of Neuroendocrinology, Discipline of Endocrinology, Department of Internal Medicine Clinical Hospital of the University of São Paulo Medical School, São Paulo, Brazil
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
October 20, 2014
First Posted
October 24, 2014
Study Start
January 1, 2011
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
May 7, 2019
Results First Posted
May 7, 2019
Record last verified: 2019-04