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SuspendedNCT02603549Updated Jan 31, 2019

Pituitary Function and Spontaneous Intracranial Hypotension

An observational study in Hyperprolactinemia and Spontaneous Intracranial Hypotension, sponsored by Cedars-Sinai Medical Center. Suspended at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-31.

Sponsored by Cedars-Sinai Medical Center · Observational

Why this study was suspended
Study protocol needs to be amended. Recruitment is halted until amendment is completed and approved by IRB.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

Previous research has identified spontaneous cerebral spinal fluid leakage as a cause for spontaneous intracranial hypotension, leading to positional headache patterns. Typical magnetic resonance imaging findings include subdural fluid collections, enhancement of pachymenginges, engorgement of venous structures, pituitary hyperemia, and sagging of the brain (SEEPS). Because pituitary hyperemia has been documented in cases of spontaneous cerebral spinal fluid leakage and is known to mimic a pituitary tumor or hyperplasia, the investigators would like to like to assess the clinical manifestations and neuroimaging abnormalities of SIH patients with regard to the pituitary gland. Specifically, the investigators are looking to analyze the compression of the pituitary stalk and conduct a systemic evaluation of pituitary function in SIH patients.

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Conditions studied

  • Hyperprolactinemia
  • Spontaneous Intracranial Hypotension
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In context

Hyperprolactinemia

39 studies on the registry are indexed under Hyperprolactinemia; 4 are open to participants now.

This study's planned enrollment of 100 is below the median of 114 across 16 observational studies indexed under Hyperprolactinemia.

Browse Hyperprolactinemia studies →

Lead sponsor

Cedars-Sinai Medical Center is the lead sponsor of 456 studies on the registry; 107 are open to participants now.

Of its 65 completed or terminated interventional studies of FDA-regulated products, 49 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with Spontaneous intracranial hypotension (SIH)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female patients
  • Age 18 years and older
  • Diagnosis of SIH:
  • LP
  • Brain MRI (SEEPS)

Exclusion criteria

Exclusion Criteria:

  • Pregnant and post-partum females
  • Nursing mothers
  • Patients with potential hyperprolactinemia due to:
  • Hypothyroidism,
  • Chronic renal disorder
  • Liver disease (including cirrhosis)
  • Primary or secondary amenorrhea
  • Polycystic Ovary Syndrome
  • Seizure disorder
  • Illicit drug use
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Surgery or Blood Patch

    Other: Pituitary panel will be drawn pre-op and post-op for all patients.

Interventions

  • OtherPituitary panel will be drawn pre-op and post-op for all patients.
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What researchers measure

Primary outcomes

  1. Comparing the levels of prolactin pre and post treatment

    Time frame: 90 days

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Study locations

1 site
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
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References and documents

Publications

  • Schievink WI. Spontaneous spinal cerebrospinal fluid leaks and intracranial hypotension. JAMA. 2006 May 17;295(19):2286-96. doi: 10.1001/jama.295.19.2286. PubMed 16705110 ↗
  • SCHALTENBRAND G. Normal and pathological physiology of the cerebrospinal fluid circulation. Lancet. 1953 Apr 25;1(6765):805-8. doi: 10.1016/s0140-6736(53)91948-5. No abstract available. PubMed 13036182 ↗
  • Mokri B. Cerebrospinal fluid volume depletion and its emerging clinical/imaging syndromes. Neurosurg Focus. 2000 Jul 15;9(1):e6. doi: 10.3171/foc.2000.9.1.6. PubMed 16859267 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02603549
Responsible party
Vivien Bonert, MD (Clinical Director, Pituitary Center, Cedars-Sinai Medical Center) — Principal investigator
First posted
Nov 13, 2015
Start date
Jul 2015
Primary completion
Dec 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Jan 31, 2019

Study contacts

Vivien Bonert, MD
principal investigator · Cedars-Sinai Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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