NCT03353025

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
394

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2017

Completed
9 months until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 24, 2017

Status Verified

November 1, 2017

Enrollment Period

10 years

First QC Date

February 20, 2017

Last Update Submit

November 20, 2017

Conditions

Prolactinoma

Keywords

non-invasive prolactinoma

Outcome Measures

Primary Outcomes (1)

  • Endocrine remission rate

    After intervention, blood prolactin normalization rate

    five-year

Study Arms (2)

transsphenoidal surgery treatment

EXPERIMENTAL

Transsphenoidal surgery treat non-invasive prolactinoma by experienced neurosurgeon

Procedure: transsphenoidal surgery treatment

dopamine agonist treatment

EXPERIMENTAL

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

Drug: dopamine agonist treatment

Interventions

transsphenoidal surgery treatmentPROCEDURE

transsphenoidal surgery treatment

Also known as: TSS
transsphenoidal surgery treatment
dopamine agonist treatmentDRUG

Minimum effective dose of dopamine agonist，bromocriptine，treat prolactinona

Also known as: DA
dopamine agonist treatment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • non-invasive prolactionma

You may not qualify if:

  • invasive prolactioma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen 5010 program

Guangzhou, China

RECRUITING

MeSH Terms

Conditions

Prolactinoma

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPituitary NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SitePituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Haijun Wang, Dr.

    First Affiliated Hospital, Sun Yat-Sen University

    STUDY CHAIR

Central Study Contacts

Zongming Wang, Dr.

CONTACT

8613570903721wzmyan@foxmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

February 20, 2017

First Posted

November 24, 2017

Study Start

January 1, 2016

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

November 24, 2017

Record last verified: 2017-11

Locations

CN(1)