Clinical trial · Interventional
Effect of Pasireotide Long Acting Release (LAR) on Gonadotroph Adenomas
Effect of Pasireotide LAR on Gonadotroph Adenomas: A Pilot Study
NCT00929669CI-TRIAL-00030532LARterminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): unable to identify a third subject
Summary
Brief summary (as posted)
The purpose of this study is to determine if administration of pasireotide LAR for one year to three patients with gonadotroph adenomas and elevated serum FSH concentrations will reduce the serum follicle-stimulating hormone (FSH) to normal and reduce the adenoma size.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gonadotroph Adenomas | Pituitary Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pasireotide LAR | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pasireotide LAR
- description
- 80 mg IM once monthly
- interventionNames
- Drug: pasireotide LAR
Primary outcomes (1)
- measure
- Number of Participants With Change in Size of the Adenoma by ≥3 mm in at Least Two Dimensions as Determined by MRI
- timeFrame
- 12 months
- description
- MRI of the pituitary will be performed at baseline, Month 6 and Month 12 to demonstrate a decrease of ≥3 mm in at least two of three dimensions on MRI (cephalocaudal, transverse, and posterior-anterior). The outcome measure is defined as the number of participants who demonstrated a ≥3 mm decrease in adenoma size in two dimensions.
Secondary outcomes (1)
- measure
- Number of Participants With Change in Serum FSH Concentration (mIU/mL) in Patients Who Have Gonadotroph Adenomas Treated With Pasireotide.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * gonadotroph adenoma Exclusion Criteria: * visual impairment attributable to the adenoma * radiation therapy * active gallbladder disease * uncontrolled diabetes
References
Publications (0)
Data not yet available
No reference posted for this study.