Study on Therapy of Non-invasive Prolactinoma (TNAPA)

November 20, 2017 updated by: Hai-Jun Wang, First Affiliated Hospital, Sun Yat-Sen University

Prospective Randomized Clinical Study on Transsphenoidal or Dopamine Drugs Therapy Treat Non-invasive Prolactinoma

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

Study Overview

Status

Recruiting

Conditions

Intervention / 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 Type

Interventional

Enrollment (Anticipated)

394

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

non-invasive prolactionma

Exclusion Criteria:

invasive prolactioma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endocrine remission rate
Time Frame: five-year
After intervention, blood prolactin normalization rate
five-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2016

Primary Completion (ANTICIPATED)

December 31, 2025

Study Completion (ANTICIPATED)

December 31, 2025

Study Registration Dates

First Submitted

February 20, 2017

First Submitted That Met QC Criteria

November 20, 2017

First Posted (ACTUAL)

November 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 24, 2017

Last Update Submitted That Met QC Criteria

November 20, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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