Monocenter, double blinded, exploratory, randomized, study investigating the influence of Pasireotide on the hormonal activity of Prolactinomas - proof of concept study

• Conditions: Prolactinoma; MedDRA version: 9.1Level: LLTClassification code 10036832Term: Prolactinoma

• Registration Number: EUCTR2006-007036-95-DE
• Lead Sponsor: niversitätsklinikum Essen - Zentrum für Innere Medizin - Klinik für Endokrinologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Male and female patients
• Age: 18 – 80 years
• Patients with Prolactinomas as shown by:
- increased serum levels of Prolactin > 150 ng/ml and
- confirmation of tumor lesion by MRT
• A wash-out phase for non de novo patients with the following timeframes:
- Bromocriptine:7 days
- Quinagolide:7 days
- Cabergoline:14 days
•Women of childbearing potential must use effective contraception during the study and for three months after study completion. A contraceptive method is considered effective when its failure rate is less than 1% per year (Pearl Index (PI)). Contraception must consist of either double-barrier contraception, oral contraceptive plus barrier contraceptive or clinically documented total hysterectomy and/or oophorectomy or tubal ligation. Postmenopausal females must show amenorrhea for at least 12 months.
• Written informed consent

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

• Clinically significant renal or hepatic abnormalities
• Evidence of drug/alcohol abuse
• The patient has received any unlicensed drug within 30 days prior to screening
• Known hypersensitivity to Somatostatin analogs
• Pregnancy or breast-feeding
• Known immunosuppression
• Hyperprolactinemia due to any other cause (e.g. anti-depressive drugs)
• Patients with risk factors for Torsade de Pointes (QT > 470 ms on screening ECG, hypokalaemia, familiar history of a Long-QT-Syndrome or concomitant medication known to prolong the QT interval)
•Heart failure (NYHA II-IV)
• Other malignant diseases, except Basalioma or in situ Cervix carcinoma

Study & Design

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