Hydrocortisone in Hormone Replacement Therapy for Large Pituitary Neuroendocrine Tumors
NCT06679816 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 882
Last updated 2025-01-14
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
Conditions
- Pituitary Adenoma
- Pituitary Neuroendocrine Tumor
Interventions
- DRUG
-
Hormone replacement therapy
Perioperative Hydrocortisone Reduction Therapy
- DRUG
-
Perioperative placebo Reduction Therapy
Sponsors & Collaborators
-
Beijing Tiantan Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-04
- Primary Completion
- 2025-12-31
- Completion
- 2026-06-30
Countries
- China
Study Locations
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