A Phase 1/2 interventional study of Ropinirole in Hyperprolactinemia and Prolactinoma, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-06-04.
Sponsored by Columbia University · Phase 1/2, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Patients with hyperprolactinemia were treated with long-term ROP therapy for 6 months in an open-label dose escalation study
Drug: Ropinirole
0.25mg/day - 6.0mg/day oral non-ergoline dopamine agonist ropinirole
Also known as: ROP therapy
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.
Time frame: 6-12 months
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.
Time frame: 6 months
| Milestone | ROP Intervention |
|---|---|
| Started | 15 |
| Completed | 11 |
| Not completed | 4 |
| Withdrew: Surgical resection | 1 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Lost to follow-up | 1 |
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.
| Participants | ROP Intervention |
|---|---|
| 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 |
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.
| participants | ROP Intervention |
|---|---|
| Number of Subjects With Stable or Decreased Tumor Size | 7 |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ROP Intervention | 0/10 (0%) | 0/10 (0%) | 8/10 (80%) |
| Event | ROP Intervention |
|---|---|
| FatigueGeneral disorders | 6/10 |
| NauseaGeneral disorders | 4/10 |
| HeadacheGeneral disorders | 2/10 |
Only 15 out of 16 enrolled subjects went on to receive study therapy; however, demographic information was collected for all 16 enrolled subjects.
| Age, Categorical(Participants) | ROP Intervention |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 15 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | ROP Intervention |
|---|---|
| Female | 16 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | ROP Intervention |
|---|---|
| Hispanic or Latino | 3 |
| Not Hispanic or Latino | 13 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | ROP Intervention |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 6 |
| White | 10 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | ROP Intervention |
|---|---|
| United States | 16 |
| Prolactin(ng/mL) | ROP Intervention |
|---|---|
| Mean | 126 ± 41.4 |
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Columbia University