Trial · NCT03038308
Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole
NCT03038308, Phase 1, Phase 2, Completed, Columbia University; results first posted 2021-07-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole. Trials, record NCT03038308. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03038308
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole
- NCT number
- NCT03038308
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- Columbia University
- Conditions
- Hyperprolactinemia, Prolactinoma
- Interventions
- Ropinirole
- First posted
- 2017-01-31
- Last updated
- 2024-06-04
- Results first posted
- 2021-07-30
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. | 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. |
| Secondary | Number of Subjects With Stable or Decreased Tumor Size | 6 months | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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. | 6-12 months | Of the 16 subjects enrolled, 1 was deemed ineligible after completion of screening, 2 relocated out of state prior to taking first dose, 1 was withdrawn after week 1 following decision to pursue surgical resection of the prolactinoma. 12 participated longitudinally -- 1 was lost to follow-up after 16 weeks; 11 subjects completed 24 weeks and 5/11 subjects continued ropinirole therapy for one year with 2/11 remaining in protocol for 17 months due pandemic related delays in final visits. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Stable or Decreased Tumor Size | 6 months | Nine participants analyzed as only 9 participants had a followup MRI at 6 months. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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. | ROP Intervention | 6 | Participants | ||
| Number of Subjects With Stable or Decreased Tumor Size | ROP Intervention | 7 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ROP Intervention | 15 | |
| Overall Study | COMPLETED | ROP Intervention | 11 | |
| Overall Study | NOT COMPLETED | ROP Intervention | 4 |
Source ClinicalTrials.gov
Adverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | ROP Intervention | 6 | 10 | |
| other | Nausea | General disorders | ROP Intervention | 4 | 10 | |
| other | Headache | General disorders | ROP Intervention | 2 | 10 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ROP Intervention | 0 | 10 |
| Total, other adverse events | ROP Intervention | 8 | 10 |
| Total, serious adverse events | ROP Intervention | 0 | 10 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21DK112093 | A New Therapeutic Option for the Treatment of Prolactinomas | PAGEWILSON, GABRIELLE | COLUMBIA UNIVERSITY HEALTH SCIENCES | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2016 to 2018 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03038308
GET https://conductscience.org/api/trials/v1/NCT03038308/registered