NCT06679816

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 882 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Hormone replacement therapy	Perioperative Hydrocortisone Reduction Therapy
DRUG	Placebo	Perioperative placebo Reduction Therapy

Timeline

• Start date: 2024-12-04
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2024-11-08
• Last updated: 2025-01-14

Locations

1 site across 1 country: China