ProlactinomaTNAPANCT03353025
Study on Therapy of Non-invasive Prolactinoma
A study testing transsphenoidal surgery treatment and dopamine agonist treatment in people with Prolactinoma, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
the study aim to investigate the endocrine remission rate of non-invasive prolactinoma between transsphenoidal surgery treatment and Dopamine agonist treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Prolactinoma
- What is being tested?
- transsphenoidal surgery treatment and dopamine agonist treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- non-invasive prolactionma
Who cannot join
- invasive prolactioma
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen 5010 program
Guangzhou
Haijun Wang, doctor, 13570903721, wanghaij@mail.sysu.edu.cn
About this study
Official title: Prospective Randomized Clinical Study on Transsphenoidal or Dopamine Drugs Therapy Treat Non-invasive Prolactinoma
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.
- Conditions
- Prolactinoma
- Being tested
- transsphenoidal surgery treatment, dopamine agonist treatment
- Keywords
- non-invasive prolactinoma
- Medical subject headings
- Prolactinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transsphenoidal surgery treatmentProcedure or surgery
Also called TSS
transsphenoidal surgery treatment
dopamine agonist treatmentDrug
Also called DA
Minimum effective dose of dopamine agonist，bromocriptine，treat prolactinona
| Study group | Role | What they receive |
|---|---|---|
| transsphenoidal surgery treatment | Experimental | Transsphenoidal surgery treat non-invasive prolactinoma by experienced neurosurgeon Receives: Procedure: transsphenoidal surgery treatment |
| dopamine agonist treatment | Experimental | Minimum effective dose of dopamine agonist, bromocriptine, treat non-invasive prolactinoma Receives: Drug: dopamine agonist treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endocrine remission rate
After intervention, blood prolactin normalization rate
Measured: five-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start1 Jan 2016
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProlactinomaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 394 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hai-Jun Wang, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Haijun Wang, Dr., Study chair, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353025
- Sponsor's protocol ID
- 2016008
- Acronym
- TNAPA
- Status last verified
- Nov 2017
- First submitted
- 20 Feb 2017
- Last updated
- 24 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Study on Transsphenoidal or Dopamine Drugs Therapy Treat Non-invasive Prolactinoma
- ClinicalTrials.gov ID
- NCT03353025
- Acronym / sponsor ID
- TNAPA / 2016008
- Conditions
- Prolactinoma
- Keywords
- non-invasive prolactinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 394 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transsphenoidal surgery treatment | Experimental | Procedure: transsphenoidal surgery treatmentTranssphenoidal surgery treat non-invasive prolactinoma by experienced neurosurgeon |
| dopamine agonist treatment | Experimental | Drug: dopamine agonist treatmentMinimum effective dose of dopamine agonist, bromocriptine, treat non-invasive prolactinoma |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- non-invasive prolactionma
Key exclusion criteria (1 listed)
- invasive prolactioma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transsphenoidal surgery treatmentAlso: TSStranssphenoidal surgery treatment | Procedure or surgery | transsphenoidal surgery treatment |
| dopamine agonist treatmentAlso: DAMinimum effective dose of dopamine agonist，bromocriptine，treat prolactinona | Drug | dopamine agonist treatment |
Primary outcome
Endocrine remission rate
Time frame: five-year
After intervention, blood prolactin normalization rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
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Safety and Potency of a High Cabergoline Dosage in Microprolactinomas
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haijun Wang, Dr. study chair
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transsphenoidal surgery treatment and dopamine agonist treatment in people with Prolactinoma, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zongming Wang, Dr. (8613570903721, wzmyan@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endocrine remission rate (time frame: five-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2017.