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Phase 2 N=15 Treatment

Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole

Hyperprolactinemia · Prolactinoma

Bottom Line

View on ClinicalTrials.gov: NCT03038308 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: 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 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Ropinirole (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Columbia University
Primary completion
Nov 2020

Outcome Measures

OutcomeResultp-value
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 —
SECONDARY
Number of Subjects With Stable or Decreased Tumor Size		 7 —

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.

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03038308). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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