HypopituitarismPhase 4NCT04902235
Identification and Clinical Relevance of an Oxytocin Deficient State (CRH Study)
A Phase 4 study testing Experimental: CRH administration in people with Hypopituitarism and Central Diabetes Insipidus, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypopituitarism, Central Diabetes Insipidus, Panhypopituitarism
- What is being tested?
- Experimental: CRH administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 6 Jul 2021to 1 May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification and Clinical Relevance of an Oxytocin Deficient State: a Randomized, Crossover, Placebo-controlled, Proof-of-concept Physiopathological Study (CRH Study)
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.
Read the detailed description
This research is focused on two groups of participants: healthy controls (HC) and hypopituitary patients (HYPO) with at least one symptom of hypothalamic damage, presumably at highest risk for OT deficiency.
The aim is to improve knowledge on the physiology and patho-physiology of endogenous OT secretion in hypopituitary patients compared to healthy controls using a randomized, single-blind, crossover assignment (CRH vs placebo), placebo-control design.
Clinical implications of secretory OT dynamics and release under different stimuli using validated questionnaires to evaluate psychopathology, socio-emotional functioning, disordered eating behavior, impaired quality of life and sexual dysfunction, will be also evaluated.
- Conditions
- Hypopituitarism, Central Diabetes Insipidus, Panhypopituitarism, Psychological Disorder, Social Isolation, Hypothalamic Diseases
- Being tested
- Experimental: CRH administration, Control: Placebo administration
- Keywords
- oxytocin, panhypopituitarism, central diabetes insipidus, hypothalamus-pituitary diseases, cortisol, ACTH, corticorelin hormone
- Medical subject headings
- Hypopituitarism, Diabetes Insipidus, Neurogenic, Combined Pituitary Hormone Deficiency, Mental Disorders, Social Isolation, Hypothalamic Diseases, Pituitary Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: CRH administrationDrug
CRH at 1.0 µg/kg/body weight will be injected intravenously as a bolus over 30 seconds and samples will be collected over 2 hours (15 (T15), 30 (T30), 45 (T45), 60 (T60'), 90 (T90) and 120 (T120) minutes) after CRH:placebo administration to assess OT secretory patterns
Control: Placebo administrationDrug
Sodium Chloride 0.9% will be administered intravenously as a bolus over 30 seconds at equivalent volume than CRH administration (1.0 µg/kg/body weight)
| Study group | Role | What they receive |
|---|---|---|
| CRH administration | Experimental | Experimental: CRH administration Receives: Drug: Experimental: CRH administration |
| Placebo administration | Placebo comparator | Control: Placebo administration Receives: Drug: Control: Placebo administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in oxytocin concentration
Change in oxytocin concentration (pg/mL) after administration of 1.0 µg/kg/body weight of CRH or 0.9% sodium chloride (NaCl)
Measured: Baseline blood exam (timepoint 0) and further blood collections after 15, 30, 45, 60, 90 and 120 minutes after baseline blood collection
Secondary outcomes (8)
Maximal change in oxytocin concentration (pg/mL)
Maximal change in oxytocin concentration (pg/mL) after administration of 1.0 µg/kg/body weight of CRH or 0.9% NaCl
Measured: Within the two hours after the injection
Overall oxytocin secretion
Oxytocin area under the curve after administration of 1.0 µg/kg/body weight of CRH or 0.9% NaCl
Measured: Within the two hours after the injection
Change in cortisol concentration (nmol/L)
Change in cortisol concentration (nmol/L) after administration of 1.0 µg/kg/body weight of CRH or 0.9% NaCl
Measured: Baseline blood exam (timepoint 0) and further blood collections after 15, 30, 45, 60, 90 and 120 minutes after baseline blood collection
Change in adrenocorticotropic hormone (ACTH) values
Change in ACTH values (pmol/L) after administration of 1.0 µg/kg/body weight of CRH or 0.9% NaCl
Measured: Baseline blood exam (timepoint 0) and further blood collections after 15, 30, 45, 60, 90 and 120 minutes after baseline blood collection
Mood assessment
Correlation between Beck Depression Inventory-2 score (range from 0 to 63, higher scores mean a worse outcome) and baseline oxytocin concentration (pg/mL)
Measured: Baseline
Quality of life assessment
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)
Measured: Baseline
Impulsivity assessment
Correlation between Barratt Impulsiveness Scale (range from 30 to 120, higher scores indicate greater impulsivity) and baseline oxytocin concentration (pg/mL)
Measured: Baseline
Alexithymia assessment
Correlation between Toronto Alexithymia scales-20 score (range from 20 to 100, higher scores mean a worse outcome) and baseline oxytocin concentration (pg/mL)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start6 Jul 2021
- Primary completion30 Apr 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypopituitarismStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-blind, randomized, placebo-controlled proof-of-concept studies with a crossover assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- Anna Aulinas, MD PhD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902235
- Sponsor's protocol ID
- IIBSP-OXI-2020-101
- Status last verified
- Mar 2022
- First submitted
- 17 May 2021
- Last updated
- 3 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Asla Q, Garrido M, Urgell E, Terzan S, Santos A, Fernandez M, Varghese N, Atila C, Calabrese A, Biagetti B, Plessow F, Gich I, Christ-Crain M, Eckert A, Webb SM, Lawson EA, Aulinas A. Oxytocin levels in response to CRH administration in hypopituitarism and hypothalamic damage: a randomized, crossover, placebo-controlled trial. Sci Rep. 2025 Jan 18;15(1):2360. doi: 10.1038/s41598-025-86566-y.
PubMed 39824923
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Clinical Relevance of an Oxytocin Deficient State: a Randomized, Crossover, Placebo-controlled, Proof-of-concept Physiopathological Study (CRH Study)
- ClinicalTrials.gov ID
- NCT04902235
- Acronym / sponsor ID
- IIBSP-OXI-2020-101
- Conditions
- Hypopituitarism, Central Diabetes Insipidus, Panhypopituitarism, Psychological Disorder, Social Isolation, Hypothalamic Diseases
- Keywords
- oxytocin, panhypopituitarism, central diabetes insipidus, hypothalamus-pituitary diseases, cortisol, ACTH, corticorelin hormone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This research is focused on two groups of participants: healthy controls (HC) and hypopituitary patients (HYPO) with at least one symptom of hypothalamic damage, presumably at highest risk for OT deficiency.
The aim is to improve knowledge on the physiology and patho-physiology of endogenous OT secretion in hypopituitary patients compared to healthy controls using a randomized, single-blind, crossover assignment (CRH vs placebo), placebo-control design.
Clinical implications of secretory OT dynamics and release under different stimuli using validated questionnaires to evaluate psychopathology, socio-emotional functioning, disordered eating behavior, impaired quality of life and sexual dysfunction, will be also evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-blind, randomized, placebo-controlled proof-of-concept studies with a crossover assignment
| Arm | Type | Receives |
|---|---|---|
| CRH administration | Experimental | Drug: Experimental: CRH administrationExperimental: CRH administration |
| Placebo administration | Placebo comparator | Drug: Control: Placebo administrationControl: Placebo administration |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: CRH administrationCRH at 1.0 µg/kg/body weight will be injected intravenously as a bolus over 30 seconds and samples will be collected over 2 hours (15 (T15), 30 (T30), 45 (T45), 60 (T60'), 90 (T90) and 120 (T120) minutes) after CRH:placebo administration to assess OT secretory patterns | Drug | CRH administration |
| Control: Placebo administrationSodium Chloride 0.9% will be administered intravenously as a bolus over 30 seconds at equivalent volume than CRH administration (1.0 µg/kg/body weight) | Drug | Placebo administration |
Primary outcome
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
Change in oxytocin concentration (pg/mL) after administration of 1.0 µg/kg/body weight of CRH or 0.9% sodium chloride (NaCl)
8 secondary outcomes
Maximal change in oxytocin concentration (pg/mL)
Time frame: Within the two hours after the injection
Overall oxytocin secretion
Time frame: Within the two hours after the injection
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
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
Mood assessment
Time frame: Baseline
Quality of life assessment
Time frame: Baseline
Impulsivity assessment
Time frame: Baseline
Alexithymia assessment
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Derived from this study: PubMed 39824923Asla Q, Garrido M, Urgell E, Terzan S, Santos A, Fernandez M, Varghese N, Atila C, Calabrese A, Biagetti B, Plessow F, Gich I, Christ-Crain M, Eckert A, Webb SM, Lawson EA, Aulinas A. Oxytocin levels in response to CRH administration in hypopituitarism and hypothalamic damage: a randomized, crossover, placebo-controlled trial. Sci Rep. 2025 Jan 18;15(1):2360. doi: 10.1038/s41598-025-86566-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Aulinas, MD PhD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Experimental: CRH administration in people with Hypopituitarism and Central Diabetes Insipidus, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04902235, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.