Study on Therapy of Non-invasive Prolactinoma

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 60 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

non-invasive prolactionma.

Exclusion Criteria:

invasive prolactioma

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03353025
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

First Affiliated Hospital, Sun Yat-Sen University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Haijun Wang, Dr.
Principal Investigator Affiliation First Affiliated Hospital, Sun Yat-Sen University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Prolactinoma
Additional Details

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.

Arms & Interventions

Arms

Experimental: transsphenoidal surgery treatment

Transsphenoidal surgery treat non-invasive prolactinoma by experienced neurosurgeon

Experimental: dopamine agonist treatment

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

Interventions

Procedure: - transsphenoidal surgery treatment

transsphenoidal surgery treatment

Drug: - dopamine agonist treatment

Minimum effective dose of dopamine agonist,bromocriptine,treat prolactinona

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Sun Yat-sen 5010 program, Guangzhou, China

Status

Recruiting

Address

Sun Yat-sen 5010 program

Guangzhou, ,

Site Contact

Haijun Wang, doctor

[email protected]

13570903721

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