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Trial · Interventional

CompletedPhase 4Registry data

Identification and Clinical Relevance of an Oxytocin Deficient State (CRH Study)

NCTNCT04902235 (opens ClinicalTrials.gov in a new tab)Other idIIBSP-OXI-2020-101
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures ACTH (corticotropin), does not give it. It appears in an outcome measure.
  • Measures Oxytocin, does not give it. It appears in an outcome measure.

Overview

Status
Completed
Phase
Phase 4
Enrollment
52 participants (actual)
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Other
Design
Randomized · Single masking
Countries
1 country

Spain

Start
6 Jul 2021
Primary completion
30 Apr 2023
Completion
1 May 2023
First posted
26 May 2021
Last update posted
3 Apr 2024
Conditions
Hypopituitarism · Central Diabetes Insipidus · Panhypopituitarism · Psychological Disorder · Social Isolation · Hypothalamic Diseases · Pituitary Diseases · Oxytocin Deficiency

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2021202220232024
  1. Ph 4

    Identification and Clinical Relevance of an Oxytocin Deficient State (CRH Study)

    NCT04902235

    6 Jul 2021 to 1 May 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Oxytocin (OT) is a hypothalamic peptide that enters the peripheral circulation via the posterior pituitary gland. OT plays a key role in regulating appetite, psychopathology, prosocial behavior and sexual function. Hypopituitarism is associated with increased obesity, increased psychopathology, sexual and prosocial dysfunction despite appropriate hormone replacement. A few studies suggest the existence of a possible OT deficient state in hypopituitarism. In animal models, corticorelin hormone (CRH) has shown to increase OT release. This study is designed to evaluate oxytocin values after administration of CRH in adults (healthy volunteers and patients with hypopituitarism). The investigators hypothesize that OT response will be blunted following CRH in patients with hypopituitarism compared to healthy controls.

Interventions

  • Experimental: CRH administrationDrug
  • Control: Placebo administrationDrug

Arms2

  • Experimental

    CRH administration

    Experimental: CRH administration

  • Placebo comparator

    Placebo administration

    Control: Placebo administration

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in oxytocin concentration

    Time frame · Baseline blood exam (timepoint 0) and further blood collections after 15, 30, 45, 60, 90 and 120 minutes after baseline blood collection

    Registry description

    Change in oxytocin concentration (pg/mL) after administration of 1.0 µg/kg/body weight of CRH or 0.9% sodium chloride (NaCl)

Secondary outcomes(8)

  1. Maximal change in oxytocin concentration (pg/mL)

    Time frame · Within the two hours after the injection

    Registry description

    Maximal change in oxytocin concentration (pg/mL) after administration of 1.0 µg/kg/body weight of CRH or 0.9% NaCl

  2. Overall oxytocin secretion

    Time frame · Within the two hours after the injection

    Registry description

    Oxytocin area under the curve after administration of 1.0 µg/kg/body weight of CRH or 0.9% NaCl

  3. Change in cortisol concentration (nmol/L)

    Time frame · Baseline blood exam (timepoint 0) and further blood collections after 15, 30, 45, 60, 90 and 120 minutes after baseline blood collection

    Registry description

    Change in cortisol concentration (nmol/L) after administration of 1.0 µg/kg/body weight of CRH or 0.9% NaCl

  4. Change in adrenocorticotropic hormone (ACTH) values

    Time frame · Baseline blood exam (timepoint 0) and further blood collections after 15, 30, 45, 60, 90 and 120 minutes after baseline blood collection

    Registry description

    Change in ACTH values (pmol/L) after administration of 1.0 µg/kg/body weight of CRH or 0.9% NaCl

  5. Mood assessment

    Time frame · Baseline

    Registry description

    Correlation between Beck Depression Inventory-2 score (range from 0 to 63, higher scores mean a worse outcome) and baseline oxytocin concentration (pg/mL)

  6. Quality of life assessment

    Time frame · Baseline

    Registry description

    Correlation between 36 item- Short Form Health Survey score (range from 0 to 100, the higher scores indicate better health status) and baseline oxytocin concentration (pg/mL)

  7. Impulsivity assessment

    Time frame · Baseline

    Registry description

    Correlation between Barratt Impulsiveness Scale (range from 30 to 120, higher scores indicate greater impulsivity) and baseline oxytocin concentration (pg/mL)

  8. Alexithymia assessment

    Time frame · Baseline

    Registry description

    Correlation between Toronto Alexithymia scales-20 score (range from 20 to 100, higher scores mean a worse outcome) and baseline oxytocin concentration (pg/mL)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2025

2 results

Oxytocin levels in response to CRH administration in hypopituitarism and hypothalamic damage: a randomized, crossover, placebo-controlled trial.

Asla et al. 2025Scientific reportscited by 7

PMID 39824923PMC11742408DOI 10.1038/s41598-025-86566-yPUB-39824923

Free to read · publisher termsCC BY-NC-ND2 results
Read at sourceSee results (2)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Patients with hypopituitarism (HYPO) (\>1 pituitary hormone deficiency) and stable hormone replacement for the prior three months * At least one clinical sign of hypothalamic damage * Female participants will be done in the early to midfollicular phase Exclusion Criteria: * uncorrected hormone deficiency * creatinine \>1.5mg/dL * alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5x upper limit of normal * hematocrit less than 30% * suicidality or active psychosis * participation in a trial with investigational drugs within 30 days * using a high glucocorticoid dose * vigorous physical exercise * alcohol intake within 24 hours before the study participation * evidence of any acute illness or any illness that the Investigator determines could interfere with study participation or safety * pregnancy or breastfeeding for last 8 weeks * known allergies towards CRH * patients refusing or unable to give written informed consent * Additionally for healthy controls: the presence of brain or pituitary tumor, radiation involving the hypothalamus or pituitary, history of hypopituitarism or receiving testosterone or glucocorticoids esters.

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