Study on Therapy of Non-invasive Prolactinoma

Not Applicable

Recruiting

• Conditions: Prolactinoma
• Interventions: Drug: dopamine agonist treatment; Procedure: transsphenoidal surgery treatment

• Registration Number: NCT03353025
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Brief Summary

the study aim to investigate the endocrine remission rate of non-invasive prolactinoma between transsphenoidal surgery treatment and Dopamine agonist treatment.

Detailed Description

Non-invasive prolactinomas were treated by transsphenoidal surgery or Dopamine agonist until now. However，this two type therapies were controversial. The study aim to investigate the endocrine remission rate of non-invasive prolactinoma between transsphenoidal surgery treatment and Dopamine agonist treatment.

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2017-02-20
• Status Verified: 2017-11
• Study First Submitted QC: 2017-11-20
• Last Update Submitted: 2017-11-20
• Study First Posted: 2017-11-24
• Last Update Posted: 2017-11-24
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 394

Inclusion Criteria

non-invasive prolactionma

Exclusion Criteria

invasive prolactioma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dopamine agonist treatment	dopamine agonist treatment	Minimum effective dose of dopamine agonist, bromocriptine, treat non-invasive prolactinoma
transsphenoidal surgery treatment	transsphenoidal surgery treatment	Transsphenoidal surgery treat non-invasive prolactinoma by experienced neurosurgeon

Primary Outcome Measures

Name	Time	Method
Endocrine remission rate	five-year	After intervention, blood prolactin normalization rate

Trial Locations

Locations (1)

Sun Yat-sen 5010 program; 🇨🇳 Guangzhou, China