Pituitary AdenomaPhase 4NCT06679816
Hydrocortisone in Hormone Replacement Therapy for Large Pituitary Neuroendocrine Tumors
A Phase 4 study testing Hormone replacement therapy in people with Pituitary Adenoma and Pituitary Neuroendocrine Tumor, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to assess the need for hydrocortisone replacement therapy during the perioperative period for large pituitary neuroendocrine tumors. The main questions it aims to answer are: Does hydrocortisone replacement therapy reduce the incidence of adrenal insufficiency in participants?… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pituitary Adenoma, Pituitary Neuroendocrine Tumor
- What is being tested?
- Hormone replacement therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 882 participants
- Where
- 1 siteChina
- Study dates
- 4 Dec 2024to 30 Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Age range: 18-70 years old;
- (2) Accept PitNETs patients who can be treated with endoscopic transsphenoidal surgery;
- (3) The maximum diameter of the tumor is ≥ 2 centimeters;
- (4) Preoperative hypothalamic pituitary adrenal axis integrity;
- (5) The subject or their legal representative signs the informed consent form
Who cannot join
- (1) Patients with a history of Cushing's disease or adrenal insufficiency;
- (2) Emergency and combined hormone therapy patients;
- (3) Pituitary stroke patients;
- (4) Patients lacking head magnetic resonance imaging;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing, Beijing Tiantan Hospital,Capital Medical University
Beijing, Beijing Municipality, 100070
xingchao wang, Dr, 15101053127, wangxc@mail.ccmu.edu.cn
About this study
Official title: Study on the Efficacy of Hydrocortisone in Perioperative Hormone Replacement Therapy for Large Pituitary Neuroendocrine Tumors:a Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled Study
The goal of this clinical trial is to assess the need for hydrocortisone replacement therapy during the perioperative period for large pituitary neuroendocrine tumors. The main questions it aims to answer are:
- Does hydrocortisone replacement therapy reduce the incidence of adrenal insufficiency in participants? Researchers will compare hydrocortisone to a placebo (a look-alike substance that contains no drug) to see if hydrocortisone works to reduce the incidence of adrenal insufficiency.
Participants will:
- Take or intravenous infusion drug hydrocortisone or a placebo every day for 2 weeks
- Visit the clinic three months after surgery for checkups and tests
- Keep a diary of their symptoms
- Conditions
- Pituitary Adenoma, Pituitary Neuroendocrine Tumor
- Being tested
- Hormone replacement therapy, Placebo
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hormone replacement therapyDrug
Perioperative Hydrocortisone Reduction Therapy
PlaceboDrug
Perioperative placebo Reduction Therapy
| Study group | Role | What they receive |
|---|---|---|
| Hormone supplementation therapy group | Experimental | Not described Receives: Drug: Hormone replacement therapy |
| Placebo therapy group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adrenal insufficiency on the first or second day after surgery
Measured: the first or second day after surgery
Secondary outcomes (1)
The incidence of adrenal insufficiency within 90 days after surgery
Measured: Within 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start4 Dec 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary AdenomaStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 882 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679816
- Sponsor's protocol ID
- HEALTH
- Status last verified
- Dec 2024
- First submitted
- 6 Nov 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Research data involves subject privacy
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy of Hydrocortisone in Perioperative Hormone Replacement Therapy for Large Pituitary Neuroendocrine Tumors:a Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled Study
- ClinicalTrials.gov ID
- NCT06679816
- Acronym / sponsor ID
- HEALTH
- Conditions
- Pituitary Adenoma, Pituitary Neuroendocrine Tumor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 882 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 8 Nov 2024 (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.
The goal of this clinical trial is to assess the need for hydrocortisone replacement therapy during the perioperative period for large pituitary neuroendocrine tumors. The main questions it aims to answer are:
- Does hydrocortisone replacement therapy reduce the incidence of adrenal insufficiency in participants? Researchers will compare hydrocortisone to a placebo (a look-alike substance that contains no drug) to see if hydrocortisone works to reduce the incidence of adrenal insufficiency.
Participants will:
- Take or intravenous infusion drug hydrocortisone or a placebo every day for 2 weeks
- Visit the clinic three months after surgery for checkups and tests
- Keep a diary of their symptoms
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hormone supplementation therapy group | Experimental | Drug: Hormone replacement therapy |
| Placebo therapy group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (1) Age range: 18-70 years old;
- (2) Accept PitNETs patients who can be treated with endoscopic transsphenoidal surgery;
- (3) The maximum diameter of the tumor is ≥ 2 centimeters;
- (4) Preoperative hypothalamic pituitary adrenal axis integrity;
- (5) The subject or their legal representative signs the informed consent form
Key exclusion criteria (4 listed)
- (1) Patients with a history of Cushing's disease or adrenal insufficiency;
- (2) Emergency and combined hormone therapy patients;
- (3) Pituitary stroke patients;
- (4) Patients lacking head magnetic resonance imaging;
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 |
|---|---|---|
| Hormone replacement therapyPerioperative Hydrocortisone Reduction Therapy | Drug | Hormone supplementation therapy group |
| PlaceboPerioperative placebo Reduction Therapy | Drug | Placebo therapy group |
Primary outcome
The incidence of adrenal insufficiency on the first or second day after surgery
Time frame: the first or second day after surgery
1 secondary outcome
The incidence of adrenal insufficiency within 90 days after surgery
Time frame: Within 90 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Individual participant dataSharing planned: Undecided. Research data involves subject privacy
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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.
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 Hormone replacement therapy in people with Pituitary Adenoma and Pituitary Neuroendocrine Tumor, run by Beijing Tiantan Hospital at 1 site in China.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 14 Jan 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xingchao wang, Phd (15101053127, wangxc@mail.ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of adrenal insufficiency on the first or second day after surgery (time frame: the first or second day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2025.