NCT03038308

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2016

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2020

Completed
9 months until next milestone

Results Posted

Study results publicly available

July 30, 2021

Completed
Last Updated

June 4, 2024

Status Verified

May 1, 2024

Enrollment Period

4.1 years

First QC Date

January 30, 2017

Results QC Date

July 9, 2021

Last Update Submit

May 31, 2024

Conditions

HyperprolactinemiaProlactinoma

Keywords

ropinirolehyperprolactinemiaprolactin

Outcome Measures

Primary Outcomes (1)

  • 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.

    6-12 months

Secondary Outcomes (1)

  • Number of Subjects With Stable or Decreased Tumor Size

    6 months

Study Arms (1)

ROP Intervention

EXPERIMENTAL

Patients with hyperprolactinemia were treated with long-term ROP therapy for 6 months in an open-label dose escalation study

Drug: Ropinirole

Interventions

RopiniroleDRUG

0.25mg/day - 6.0mg/day oral non-ergoline dopamine agonist ropinirole

Also known as: ROP therapy
ROP Intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

  • 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.

    PMID: 30362146BACKGROUND

MeSH Terms

Conditions

HyperprolactinemiaProlactinoma

Interventions

ropinirole

Condition Hierarchy (Ancestors)

HyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPituitary NeoplasmsEndocrine Gland NeoplasmsNeoplasms by Site

Results Point of Contact

Title
Gabrielle Page-Wilson, MD
Organization
Columbia University
gp2287@cumc.columbia.edu
212-305-3725

Study Officials

  • Gabrielle Page-Wilson, M.D.

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Masking Details
Open-label studies
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2017

First Posted

January 31, 2017

Study Start

September 16, 2016

Primary Completion

November 5, 2020

Study Completion

November 5, 2020

Last Updated

June 4, 2024

Results First Posted

July 30, 2021

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)