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

Phase 1

• Conditions: Hyperprolactinaemia; MedDRA version: 12.1Level: LLTClassification code 10020737Term: Hyperprolactinaemia

• Registration Number: EUCTR2010-021403-24-GB
• Lead Sponsor: orth Lincolnshire and Goole NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-08
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>2. Does treatment with quinagolide have a favorable effect on the psychological symptoms associated with hyperprolactinaemia.<br><br>3. Is there any difference in psychological symptoms scoring between the two dopamine agonist treatments.<br><br>4. Is there a cohort of patients with resistant psychological symptoms to the available dopamine agonist treatment. <br>;Primary end point(s): Psychological assessment administered by questionnaires (attached). <br><br>All questionnaires are validated and published instruments. They should take no longer than 20 minutes to complete.<br>