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NCT03353025 Clinical Trial

Study on Therapy of Non-invasive Prolactinoma

Prolactinoma Clinical Trial

— TNAPA  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03353025
Other study ID # 2016008
Secondary ID
Status Recruiting
Phase N/A
First received February 20, 2017
Last updated November 20, 2017
Start date January 1, 2016
Est. completion date December 31, 2025

Study information
Verified date November 2017
Source First Affiliated Hospital, Sun Yat-Sen University
Contact Zongming Wang, Dr.
Phone 8613570903721
Email wzmyan@foxmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 394
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

non-invasive prolactionma

Exclusion Criteria:

invasive prolactioma

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• transsphenoidal surgery treatment
transsphenoidal surgery treatment
Drug:
• dopamine agonist treatment
Minimum effective dose of dopamine agonist,bromocriptine,treat prolactinona

Locations
Country Name City State
China Sun Yat-sen 5010 program Guangzhou

Sponsors (1)
Lead Sponsor Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Endocrine remission rate After intervention, blood prolactin normalization rate five-year
See also
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Not yet recruiting NCT03400865 - Cabergoline Combined Hydroxychloroquine/Chloroquine to Treat Resistant Prolactinomas N/A
Completed NCT00481299 - Insulin Resistance in Women With Prolactinoma N/A
Terminated NCT04106531 - Validation of a Quality of Life Metric "Prolac-10"
Completed NCT01504399 - Rhinological Outcomes in Endonasal Pituitary Surgery
Recruiting NCT03474601 - Seoul National University Pituitary Disease Cohort Study
Recruiting NCT04107480 - PRolaCT - Three Prolactinoma RCTs Phase 4
Completed NCT00697814 - Clomiphene in Males With Prolactinomas and Persistent Hypogonadism Phase 2
Completed NCT05236829 - Exercise Capacity and Physical Activity Level in Prolactinoma Patients
Recruiting NCT03457389 - Comparison of Treatment Outcome of Cabergoline According to Target Prolactin Levels in Patients With Prolactinoma N/A
Recruiting NCT01775332 - Interdisciplinary Pituitary Disorders Centre of Excellence: Assessment of Patient Education Tools N/A
Not yet recruiting NCT03717454 - Dopamine D2 Receptors(D2R) Imaging in Prolactinomas N/A
Recruiting NCT00001595 - An Investigation of Pituitary Tumors and Related Hypothalmic Disorders