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NCT00929669 · REGISTRY CONDITION SEARCH

Effect of Pasireotide Long Acting Release (LAR) on Gonadotroph Adenomas

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2017-11-28

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Change in Size of the Adenoma by ≥3 mm in at Least Two Dimensions as Determined by MRI

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outcome · POSTED

Number of Participants With Change in Serum FSH Concentration (mIU/mL) in Patients Who Have Gonadotroph Adenomas Treated With Pasireotide.

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * gonadotroph adenoma Exclusion Criteria: * visual impairment attributable to the adenoma * radiation therapy * active gallbladder disease * uncontrolled diabetes
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    80 mg IM once monthly
    intervention Names
    1. Drug: pasireotide LAR
    label
    Pasireotide LAR
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Pasireotide LAR
    description
    pasireotide LAR 80 mg IM once a month
    name
    pasireotide LAR
    other Names
    1. SOM230
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
2
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. 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.
    measure
    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
secondary Outcomes
  1. description
    Serum FSH (mIU/mL) will be measured at baseline and then monthly for the 12 months of the study to determine if serum FSH concentrations decrease by 20%.
    measure
    Number of Participants With Change in Serum FSH Concentration (mIU/mL) in Patients Who Have Gonadotroph Adenomas Treated With Pasireotide.
    time Frame
    12 months
Full study description
brief Summary
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.
detailed Description
Gonadotroph adenomas are the most common pituitary macroadenomas. Currently no medical treatment as been found that decreases the size of these adenomas, so surgery is the only treatment. 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.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
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      requested nct id
      NCT00929669
      primary nct id
      NCT00929669
      source kind
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      source record id
      Source null
      source file sha256
      3ef78ce4ecba793eb2b9932bd51babe9d6d7cee15aba0d82d9e98002353b720a
      payload sha256
      8b83422097559195b990e267edba825851de4eeb2d41f7e3a179b7ac08732cdb
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-028b04bdae5ac100a27c
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00929669
      occurrences
      1. context exact
        NCT00929669
        end
        11
        exact text
        NCT00929669
        start
        0
      offset unit
      unicode_code_points
      query cond
      Pituitary Tumors
      query disease state id
      ds-pituitary-tumors
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-pituitary-tumors-000.json
      source file sha256
      3ef78ce4ecba793eb2b9932bd51babe9d6d7cee15aba0d82d9e98002353b720a
      source json pointer
      /studies/7/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      2c7fd459bba36a7588d5ef5c0ba5dcd0424bf955940b18ffefc45a0bc4111fbf

    Preserved source evidence · Not medical advice