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TNAPA: Study on Therapy of Non-invasive Prolactinoma

Sponsor
First Affiliated Hospital, Sun Yat-Sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03353025
Collaborator
(none)
394
Enrollment
1
Location
2
Arms
120
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: transsphenoidal surgery treatment
  • Drug: dopamine agonist treatment
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
394 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Randomized Clinical Study on Transsphenoidal or Dopamine Drugs Therapy Treat Non-invasive Prolactinoma
Actual Study Start Date :
Jan 1, 2016
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: transsphenoidal surgery treatment

Transsphenoidal surgery treat non-invasive prolactinoma by experienced neurosurgeon

Procedure: transsphenoidal surgery treatment
transsphenoidal surgery treatment
Other Names:
  • TSS

    		•
    Experimental: dopamine agonist treatment

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

    Drug: dopamine agonist treatment
    Minimum effective dose of dopamine agonist，bromocriptine，treat prolactinona
    Other Names:
  • DA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Endocrine remission rate [five-year]

      After intervention, blood prolactin normalization rate

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    non-invasive prolactionma

    Exclusion Criteria:

    invasive prolactioma

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sun Yat-sen 5010 program Guangzhou China

    Sponsors and Collaborators

    • First Affiliated Hospital, Sun Yat-Sen University

    Investigators

    • Study Chair: Haijun Wang, Dr., First Affiliated Hospital, Sun Yat-Sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hai-Jun Wang, director, First Affiliated Hospital, Sun Yat-Sen University
    ClinicalTrials.gov Identifier:
    NCT03353025
    Other Study ID Numbers:
    • 2016008
    First Posted:
    Nov 24, 2017
    Last Update Posted:
    Nov 24, 2017
    Last Verified:
    Nov 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hai-Jun Wang, director, First Affiliated Hospital, Sun Yat-Sen University
    non-invasive prolactinoma
    Additional relevant MeSH terms:
    Prolactinoma
    Dopamine
    Dopamine Agonists

    Study Results

    No Results Posted as of Nov 24, 2017