EUCTR2006-007036-95-DEActive, not recruitingNot Applicable
Monocenter, double blinded, exploratory, randomized, study investigating the influence of Pasireotide on the hormonal activity of Prolactinomas - proof of concept study
niversitätsklinikum Essen - Zentrum für Innere Medizin - Klinik für Endokrinologie0 sitesStarted: January 23, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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