Study on Therapy of Non-invasive Prolactinoma (TNAPA)

Sun Yat-sen University

Status: Enrolling

Conditions: Prolactinoma

Treatments: Drug: dopamine agonist treatment; Procedure: transsphenoidal surgery treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03353025

2016008

Details and patient eligibility

About

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

Full 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.

Enrollment: 394 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

non-invasive prolactionma

Exclusion criteria

invasive prolactioma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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394 participants in 2 patient groups

transsphenoidal surgery treatment

Experimental group

Description:

Transsphenoidal surgery treat non-invasive prolactinoma by experienced neurosurgeon

Treatment:

Procedure: transsphenoidal surgery treatment

dopamine agonist treatment

Experimental group

Description:

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

Treatment:

Drug: dopamine agonist treatment