Prospective Randomized Clinical Study on Transsphenoidal or Dopamine Drugs Therapy Treat Non-invasive Prolactinoma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 394
- Locations
- 1
- Primary Endpoint
- Endocrine remission rate
Study Overview
Brief Summary
the study aim to investigate the endocrine remission rate of non-invasive prolactinoma between transsphenoidal surgery treatment and Dopamine agonist 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •non-invasive prolactionma
Exclusion Criteria
- •invasive prolactioma
Arms & Interventions
transsphenoidal surgery treatment
Transsphenoidal surgery treat non-invasive prolactinoma by experienced neurosurgeon
Intervention: transsphenoidal surgery treatment (Procedure)
dopamine agonist treatment
Minimum effective dose of dopamine agonist, bromocriptine, treat non-invasive prolactinoma
Intervention: dopamine agonist treatment (Drug)
Outcomes
Primary Outcomes
Endocrine remission rate
Time Frame: five-year
After intervention, blood prolactin normalization rate
Secondary Outcomes
No secondary outcomes reported
Investigators
Hai-Jun Wang
director
First Affiliated Hospital, Sun Yat-Sen University