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Effect of Pasireotide Long Acting Release (LAR) on Gonadotroph Adenomas
Plain-language guide to NCT00929669: phase 2 interventional trial of Pasireotide, 2 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00929669
- Phase
- phase 2
- Status
- terminated early
- Start
- 2009-06
- Completion (planned or actual)
- 2011-11
- Participants
- 2 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Gonadotroph Adenomas
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Pasireotide.
It had 1 arm (groups): Pasireotide LAR (experimental).
The registry classes the interventions as drug.
More on the Plan
Gonadotroph adenomas are the most common pituitary macroadenomas.
The reason to think that pasireotide might affect gonadotroph adenomas is that pasireotide binds avidly to somatostatin subtype 5 receptors, and gonadotroph adenomas express these receptors.
For this study, three subjects who have gonadotroph adenomas, as judged by a macroadenoma of the pituitary and elevated serum FSH concentration, will be treated with a long-acting form of pasireotide once a month for one year.
The effect of pasireotide on the size of the adenoma will be determined by MRI, and FSH secretion will be judged by the serum concentration.
Who Took Part
2 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: visual impairment attributable to the adenoma; radiation therapy; active gallbladder disease.
How the Study Was Run
The set-up was single-group and open-label.
Being open-label, the Pasireotide study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2009-06 with completion listed for 2011-11.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Number of Participants With Change in Size of the Adenoma by ≥3 mm in at Least Two Dimensions as Determined by MRI (time frame: 12 months).
It also tracked 1 secondary outcome, for example Number of Participants With Change in Serum FSH Concentration (mIU/mL) in Patients Who Have Gonadotroph Adenomas Treated With Pasireotide.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Pasireotide in 2 people.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); results are posted on the registry, and this page does not restate them.
More context: the Pasireotide compound page, all human trials.
Our Notes on the Compound
Pasireotide: An FDA-approved multi-receptor somatostatin analog for Cushing's disease and acromegaly; high blood sugar is a common side effect.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.