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Study on Therapy of Non-invasive Prolactinoma (TNAPA)

Primary Purpose

Prolactinoma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transsphenoidal surgery treatment
dopamine agonist treatment
Sponsored by
First Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prolactinoma focused on measuring non-invasive prolactinoma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

non-invasive prolactionma

Exclusion Criteria:

invasive prolactioma

Sites / Locations

  • Sun Yat-sen 5010 programRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

transsphenoidal surgery treatment

dopamine agonist treatment

Arm Description

Transsphenoidal surgery treat non-invasive prolactinoma by experienced neurosurgeon

Minimum effective dose of dopamine agonist, bromocriptine, treat non-invasive prolactinoma

Outcomes

Primary Outcome Measures

Endocrine remission rate
After intervention, blood prolactin normalization rate

Secondary Outcome Measures

Full Information

First Posted
February 20, 2017
Last Updated
November 20, 2017
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03353025
Brief Title
Study on Therapy of Non-invasive Prolactinoma
Acronym
TNAPA
Official Title
Prospective Randomized Clinical Study on Transsphenoidal or Dopamine Drugs Therapy Treat Non-invasive Prolactinoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prolactinoma
Keywords
non-invasive prolactinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
394 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
transsphenoidal surgery treatment
Arm Type
Experimental
Arm Description
Transsphenoidal surgery treat non-invasive prolactinoma by experienced neurosurgeon
Arm Title
dopamine agonist treatment
Arm Type
Experimental
Arm Description
Minimum effective dose of dopamine agonist, bromocriptine, treat non-invasive prolactinoma
Intervention Type
Procedure
Intervention Name(s)
transsphenoidal surgery treatment
Other Intervention Name(s)
TSS
Intervention Description
transsphenoidal surgery treatment
Intervention Type
Drug
Intervention Name(s)
dopamine agonist treatment
Other Intervention Name(s)
DA
Intervention Description
Minimum effective dose of dopamine agonist，bromocriptine，treat prolactinona
Primary Outcome Measure Information:
Title
Endocrine remission rate
Description
After intervention, blood prolactin normalization rate
Time Frame
five-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: non-invasive prolactionma Exclusion Criteria: invasive prolactioma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zongming Wang, Dr.
Phone
8613570903721
Email
wzmyan@foxmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haijun Wang, Dr.
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Sun Yat-sen 5010 program
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haijun Wang, doctor
Phone
13570903721
Email
wanghaij@mail.sysu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

Study on Therapy of Non-invasive Prolactinoma

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