NCT06679816RecruitingPhase 4
Hydrocortisone in Hormone Replacement Therapy for Large Pituitary Neuroendocrine Tumors
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
Source: ClinicalTrials.gov · Last updated 14 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 882 (estimated)
- First submitted
- 6 Nov 2024
- Start date
- 4 Dec 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Beijing Tiantan Hospital
- Diseases
- Neuroendocrine tumours
- NCT number
- NCT06679816
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 882
- From 4 Dec 2024 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- (2) Emergency and combined hormone therapy patients;
Other illness
- (1) Patients with a history of Cushing's disease or adrenal insufficiency;
- (3) Pituitary stroke patients;
Other
- (4) Patients lacking head magnetic resonance imaging;
Who the study is looking for
- (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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing, Beijing Tiantan Hospital,Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.