ClinicalTrials.gg
RecruitingNCT06679816Updated Jan 14, 2025

Hydrocortisone in Hormone Replacement Therapy for Large Pituitary Neuroendocrine Tumors

A Phase 4 interventional study of Hormone replacement therapy and Placebo in Pituitary Adenoma and Pituitary Neuroendocrine Tumor, sponsored by Beijing Tiantan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-01-14.

Sponsored by Beijing Tiantan Hospital · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Dec 2024; still recruiting 1 year 11 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
882
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 30 studies in Pituitary Neoplasms with a site in China — 8 open to participants now, 11 under way, none of them phase 3. Pituitary Neoplasms · China.

Planned enrollment
Largest of 15
882 · median 112
Started
2024
with 2 others
Phase 4
3 of 30
1 open now
Primary completion
2025-12
later than 6 of 10 live
Registered
26th of 30
by date
Lead sponsor
4 of 30
Beijing Tiantan Hospital

Among the 30 studies in Pituitary Neoplasms with a site in China, this one has the largest planned enrollment of the 15 interventional ones that give a count, is one of 3 that started in 2024, is one of 3 in phase 4, reaches primary completion later than 6 of the 10 other live ones, and was the 26th registered.

Pituitary Neoplasms

200 studies on the registry are indexed under Pituitary Neoplasms; 51 are open to participants now.

Browse Pituitary Neoplasms studies →

Open to participants now

8 of the 30 studies in Pituitary Neoplasms with a site in China are open now. Recruiting first, the newest first:

2 more — sign in →

All 8 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 36 Pituitary Neoplasms studies recruiting now, 14 (39%) set no upper age limit and 10 (28%) stop at 75 or younger; 6 take children under 18; 4 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · no healthy volunteers.

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02

Study 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? 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
03

Conditions studied

  • Pituitary Adenoma
  • Pituitary Neuroendocrine Tumor

Browse trials for

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

  • (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 form

Exclusion criteria

Exclusion Criteria:

  • (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;
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
882 participants (estimated)

Study arms

  • Experimental
    Hormone supplementation therapy group

    Drug: Hormone replacement therapy

  • Placebo comparator
    Placebo therapy group

    Drug: Placebo

Interventions

  • DrugHormone replacement therapy

    Perioperative Hydrocortisone Reduction Therapy

  • DrugPlacebo

    Perioperative placebo Reduction Therapy

06

What researchers measure

Primary outcomes

  1. The incidence of adrenal insufficiency on the first or second day after surgery

    Time frame: the first or second day after surgery

Secondary outcomes

  1. The incidence of adrenal insufficiency within 90 days after surgery

    Time frame: Within 90 days after surgery

07

Study locations

1 of 1 sites recruiting
  • Beijing, Beijing Tiantan Hospital,Capital Medical University
    Beijing, Beijing 100070, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — Research data involves subject privacy

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2024 (actual). Primary completion is estimated for Dec 2025, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2024
First posted
Nov 8, 2024
StartActual
Dec 4, 2024
Primary completionEst.
Dec 31, 2025
CompletionEst.
Jun 30, 2026
Last update
Jan 14, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06679816
Responsible party
Sponsor
First posted
Nov 8, 2024
Start date
Dec 4, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Jan 14, 2025

Study contacts

xingchao wang, Phd
Contact
wangxc@mail.ccmu.edu.cn
15101053127

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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