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A Prospective Pilot Study to Investigate the Effectiveness of Quinagolide in the Improvement of Psychological Symptoms Associated with Hyperprolactinaemia. - A)Dopamine agonists and psychological disorders of hyperprolactinaemia

A Prospective Pilot Study to Investigate the Effectiveness of Quinagolide in the Improvement of Psychological Symptoms Associated with Hyperprolactinaemia. - A)Dopamine agonists and psychological disorders of hyperprolactinaemia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-021403-24-GB
Enrollment
40
Registered
2010-10-08
Start date
2010-11-10
Completion date
Unknown
Last updated
2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperprolactinaemia MedDRA version: 12.1 Level: LLT Classification code 10020737 Term: Hyperprolactinaemia

Interventions

Trade Name: NORPROLAC Pharmacotherapeutic group: prolactin inhibitors (ATC code G02C B04). Product Name: Qunagolide Pharmaceutical Form: Tablet INN or Proposed INN: QUINAGOLIDE HYDROCHLORIDE CAS Numbe

Sponsors

North Lincolnshire and Goole NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Hyperprolactinaemia proven by a prolactin day profile. 2. Age 18-80 3. Absence of indication for pituitary surgery. 4. No prior treatment with Dopamine agonists or off treatment for at least 12 weeks before recruitment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Ongoing treatment with Dopamine receptor modulating treatment. 2. Drug induced hyperprolactinaemia. 3. Stalk syndrome or other (non lactotrophe) active pituitary adenoma. 4. Pregnancy or breast-feeding. 5. Prior treatment with dopamine agonists within 12 weeks of recruitment. 6. Prior pituitary surgery or radiotherapy within one year of recruitment. 7. Unreplaced pituitary hormone deficiency or uncontrolled hypersecretion state. 8. Known psychiatric disorder at the time of recruitment.

Design outcomes

Primary

MeasureTime frame
Main Objective: Whether treatment with Quinagolide is superior to Bromocriptine in improving psychological symptoms associated with Hyperprolactinaemia.;Secondary Objective: 1. Are there substantial psychological symptoms associated with primary hyperprolactinaemia. 2. Does treatment with quinagolide have a favorable effect on the psychological symptoms associated with hyperprolactinaemia. 3. Is there any difference in psychological symptoms scoring between the two dopamine agonist treatments. 4. Is there a cohort of patients with resistant psychological symptoms to the available dopamine agonist treatment. ;Primary end point(s): Psychological assessment administered by questionnaires (attached). All questionnaires are validated and published instruments. They should take no longer than 20 minutes to complete.—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026