A Pilot Study of Pre- and Post-operative Use of Somatuline Depot.
Status:
Terminated
Trial end date:
2016-01-01
Target enrollment:
Participant gender:
Summary
If someone is diagnosed with a pituitary tumor that causes acromegaly (too much growth
hormone) the treatment is to have it surgically removed. This study has two phases.
The first phase provides medical treatment with a drug that will be provided for 3 months
before surgery to see if complications of surgery are reduced and to see whether or not
remission improves following surgery if you have this medical treatment. The drug
administered is approved by the FDA for long-term treatment of acromegaly. It is not
routinely administered before surgery, and is therefore experimental as used in this way. All
other procedures performed during this research are standard of care with the exception of
the 3 questionnaires to be completed at each visit.
The second phase of this study is from 3 months until 12 months after surgery and is only for
people who do not go into remission after the operation. This phase assesses the possible
remission of acromegaly after resuming the drug treatment for an additional 3 to 9 months.
The drug will be prescribed by your physician as part of your regular medical care and will
not be included as part of the study. All other procedures performed during this research are
standard of care with the exception of the 3 questionnaires to be completed at each visit.
The study lasts approximately 16 months - 3 month before surgery and 12 months after surgery.