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RecruitingNCT03353025TNAPAUpdated Nov 24, 2017

Study on Therapy of Non-invasive Prolactinoma

An interventional study of transsphenoidal surgery treatment and dopamine agonist treatment in Prolactinoma, sponsored by First Affiliated Hospital, Sun Yat-Sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-11-24.

Sponsored by First Affiliated Hospital, Sun Yat-Sen University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 1 month after the study started (first participant enrolled Jan 2016, registered Feb 2017).
  • Started Jan 2016; still recruiting 10 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
394
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Prolactinoma

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Keywords

  • non-invasive prolactinoma
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In context

Prolactinoma

28 studies on the registry are indexed under Prolactinoma; 5 are open to participants now.

This study's planned enrollment of 394 is above the median of 55 across 14 interventional studies indexed under Prolactinoma.

Browse Prolactinoma studies →

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 162 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

non-invasive prolactionma

Exclusion criteria

Exclusion Criteria:

invasive prolactioma

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
394 participants (estimated)

Study arms

  • Experimental
    transsphenoidal surgery treatment

    Transsphenoidal surgery treat non-invasive prolactinoma by experienced neurosurgeon

    Procedure: transsphenoidal surgery treatment

  • Experimental
    dopamine agonist treatment

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

    Drug: dopamine agonist treatment

Interventions

  • Proceduretranssphenoidal surgery treatment

    transsphenoidal surgery treatment

    Also known as: TSS

  • Drugdopamine agonist treatment

    Minimum effective dose of dopamine agonist,bromocriptine,treat prolactinona

    Also known as: DA

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What researchers measure

Primary outcomes

  1. Endocrine remission rate

    After intervention, blood prolactin normalization rate

    Time frame: five-year

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Study locations

1 of 1 sites recruiting
  • Sun Yat-sen 5010 program
    Guangzhou, China
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03353025
Responsible party
Hai-Jun Wang (director, First Affiliated Hospital, Sun Yat-Sen University) — Principal investigator
First posted
Nov 24, 2017
Start date
Jan 1, 2016
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Nov 24, 2017

Study contacts

Zongming Wang, Dr.
Contact
wzmyan@foxmail.com
8613570903721
Haijun Wang, Dr.
study chair · First Affiliated Hospital, Sun Yat-Sen University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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