HyperprolactinemiaPhase 1/2NCT03038308
Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole
A Phase 1/2 study testing Ropinirole in people with Hyperprolactinemia and Prolactinoma, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the use of the non-ergoline dopamine agonist ropinirole for the treatment of hyperprolactinemia in patients with idiopathic hyperprolactinemia and prolactinomas. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hyperprolactinemia, Prolactinoma
- What is being tested?
- Ropinirole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2016to 5 Nov 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-70 years
- Prolactin level (PRL) ≥2 times upper limit of normal
- Pituitary adenomas on MRI ≤ 1.5cm in greatest diameter and ≥ 5mm from the optic chiasm
- Normal renal and liver function
- Agrees to barrier contraception if pre-menopausal
Who cannot join
- Use of medications known to interfere with PRL secretion and PRL and Ropinirole (ROP) metabolism
- Use of another dopamine agonist during the 4 weeks prior
- Pituitary stalk compression on MRI
- History of visual field abnormalities or previous radiation
- Untreated hypothyroidism
- Consumption of > 2 alcoholic drinks per day
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole: A Dose Escalation Study of Efficacy and Tolerability
The purpose of this study is to evaluate the use of the non-ergoline dopamine agonist ropinirole for the treatment of hyperprolactinemia in patients with idiopathic hyperprolactinemia and prolactinomas.
Read the detailed description
Treatment of prolactin secreting pituitary tumors with traditional ergot dopamine agonist drugs can be limited by medication side effects, pharmacologic resistance, and by concerns regarding the potential risk of cardiac valve disease. The overall goal of this project is therefore to evaluate, for the first time, the efficacy and tolerability of the selective D2/D3 receptor non-ergot dopamine agonist ropinirole for the treatment of prolactinomas. This proposal will establish the pharmacologic profile of this medication when used to treat hyperprolactinemia in patients with prolactinomas and will determine the impact of long-term ropinirole administration on critical clinical parameters including serum prolactin levels, gonadal function, and tumor regression, in order to establish ropinirole's utility as a new, clinically efficacious, safer and more tolerable therapeutic option for the treatment of prolactinomas that may prove particularly useful in patients with underlying cardiac valve disease and in those with resistance or intolerance to ergot dopamine agonists.
- Conditions
- Hyperprolactinemia, Prolactinoma
- Being tested
- Ropinirole
- Keywords
- ropinirole, hyperprolactinemia, prolactin
- Medical subject headings
- Hyperprolactinemia, Prolactinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopiniroleDrug
Also called ROP therapy
0.25mg/day - 6.0mg/day oral non-ergoline dopamine agonist ropinirole
| Study group | Role | What they receive |
|---|---|---|
| ROP Intervention | Experimental | Patients with hyperprolactinemia were treated with long-term ROP therapy for 6 months in an open-label dose escalation study Receives: Drug: Ropinirole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects That Achieved PRL Normalization as Defined by a Serum Prolactin Level Less Than 25ng/mL at Any Time Point During the Study Treatment Period.
Serum prolactin concentrations (PRL levels) were measured in patients at baseline, 2 and 4 weeks after starting therapy and then once monthly thereafter for 24 weeks. Serum prolactin was measured in duplicate by two-site chemiluminescent enzyme immunometric assay using the Immulite 1000 Analyzer (Siemens Healthcare Diagnostics, Deerfield, IL). The reference range for serum prolactin is 1.9-25 ng/ml for adult females.
Measured: 6-12 months
Secondary outcomes (1)
Number of Subjects With Stable or Decreased Tumor Size
Number of subjects with stable or decreased tumor size from baseline assessment to assessment after 6 months of treatment. Radiologic assessment of tumor size before and after treatment will be made by MRI.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start16 Sep 2016
- Primary completion5 Nov 2020
- Study completion5 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperprolactinemiaStudies of the same condition, open and under way.
- More trials run by Columbia 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 1\) Forced titration dose response PKPD study and 2) A prospective open-label outpatient dose escalation trial of ropinirole for treatment of prolactinomas and hyperprolactinemia.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabrielle Page-Wilson, M.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038308
- Sponsor's protocol ID
- AAAI8604
- Other IDs
- 1R21DK112093-01
- Status last verified
- May 2024
- First submitted
- 30 Jan 2017
- Last updated
- 4 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu S, Hu C, Peters J, Tsang A, Cremers S, Bies R, Page-Wilson G. Pharmacokinetics and pharmacodynamics of ropinirole in patients with prolactinomas. Br J Clin Pharmacol. 2019 Feb;85(2):366-376. doi: 10.1111/bcp.13802. Epub 2018 Nov 22.
PubMed 30362146Heneghan LJ, Tsang A, Dimino C, Khandji AG, Panigrahi SK, Page-Wilson G. Ropinirole for the Treatment of Hyperprolactinemia: A Dose-Escalation Study of Efficacy and Tolerability. J Clin Endocrinol Metab. 2024 Jan 18;109(2):e667-e674. doi: 10.1210/clinem/dgad545.
PubMed 37715962
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole: A Dose Escalation Study of Efficacy and Tolerability
- ClinicalTrials.gov ID
- NCT03038308
- Acronym / sponsor ID
- AAAI8604
- Conditions
- Hyperprolactinemia, Prolactinoma
- Keywords
- ropinirole, hyperprolactinemia, prolactin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 16 Sep 2016 (actual)
- Primary completion
- 5 Nov 2020 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Posted 30 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the use of the non-ergoline dopamine agonist ropinirole for the treatment of hyperprolactinemia in patients with idiopathic hyperprolactinemia and prolactinomas.
Detailed description
Treatment of prolactin secreting pituitary tumors with traditional ergot dopamine agonist drugs can be limited by medication side effects, pharmacologic resistance, and by concerns regarding the potential risk of cardiac valve disease. The overall goal of this project is therefore to evaluate, for the first time, the efficacy and tolerability of the selective D2/D3 receptor non-ergot dopamine agonist ropinirole for the treatment of prolactinomas. This proposal will establish the pharmacologic profile of this medication when used to treat hyperprolactinemia in patients with prolactinomas and will determine the impact of long-term ropinirole administration on critical clinical parameters including serum prolactin levels, gonadal function, and tumor regression, in order to establish ropinirole's utility as a new, clinically efficacious, safer and more tolerable therapeutic option for the treatment of prolactinomas that may prove particularly useful in patients with underlying cardiac valve disease and in those with resistance or intolerance to ergot dopamine agonists.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 1) Forced titration dose response PKPD study and 2) A prospective open-label outpatient dose escalation trial of ropinirole for treatment of prolactinomas and hyperprolactinemia.
| Arm | Type | Receives |
|---|---|---|
| ROP Intervention | Experimental | Drug: RopinirolePatients with hyperprolactinemia were treated with long-term ROP therapy for 6 months in an open-label dose escalation study |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages 18-70 years
- Prolactin level (PRL) ≥2 times upper limit of normal
- Pituitary adenomas on MRI ≤ 1.5cm in greatest diameter and ≥ 5mm from the optic chiasm
- Normal renal and liver function
- Agrees to barrier contraception if pre-menopausal
Key exclusion criteria (7 listed)
- Use of medications known to interfere with PRL secretion and PRL and Ropinirole (ROP) metabolism
- Use of another dopamine agonist during the 4 weeks prior
- Pituitary stalk compression on MRI
- History of visual field abnormalities or previous radiation
- Untreated hypothyroidism
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 |
|---|---|---|
| RopiniroleAlso: ROP therapy0.25mg/day - 6.0mg/day oral non-ergoline dopamine agonist ropinirole | Drug | ROP Intervention |
Primary outcome
Percentage of Subjects That Achieved PRL Normalization as Defined by a Serum Prolactin Level Less Than 25ng/mL at Any Time Point During the Study Treatment Period.
Time frame: 6-12 months
Serum prolactin concentrations (PRL levels) were measured in patients at baseline, 2 and 4 weeks after starting therapy and then once monthly thereafter for 24 weeks. Serum prolactin was measured in duplicate by two-site chemiluminescent enzyme immunometric assay using the Immulite 1000 Analyzer (Siemens Healthcare Diagnostics, Deerfield, IL). The reference range for serum prolactin is 1.9-25 ng/ml for adult females.
1 secondary outcome
Number of Subjects With Stable or Decreased Tumor Size
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30362146Liu S, Hu C, Peters J, Tsang A, Cremers S, Bies R, Page-Wilson G. Pharmacokinetics and pharmacodynamics of ropinirole in patients with prolactinomas. Br J Clin Pharmacol. 2019 Feb;85(2):366-376. doi: 10.1111/bcp.13802. Epub 2018 Nov 22.
- Derived from this study: PubMed 37715962Heneghan LJ, Tsang A, Dimino C, Khandji AG, Panigrahi SK, Page-Wilson G. Ropinirole for the Treatment of Hyperprolactinemia: A Dose-Escalation Study of Efficacy and Tolerability. J Clin Endocrinol Metab. 2024 Jan 18;109(2):e667-e674. doi: 10.1210/clinem/dgad545.
- Individual participant dataSharing planned: No
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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.
Gabrielle Page-Wilson, M.D. principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ropinirole in people with Hyperprolactinemia and Prolactinoma, run by Columbia University at 1 site in United States.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 4 Jun 2024. 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 United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects That Achieved PRL Normalization as Defined by a Serum Prolactin Level Less Than 25ng/mL at Any Time Point During the Study Treatment Period. (time frame: 6-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03038308, which also lists 2 linked publications.
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 4 Jun 2024.