Response to Cabergoline and Pasireotide in Non-functioning Pituitary Adenomas and Resistant Prolactinomas
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ClinicalTrials.gov Identifier: NCT01620138 |
Recruitment Status :
Completed
First Posted : June 15, 2012
Results First Posted : June 16, 2016
Last Update Posted : August 22, 2016
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Non-functioning Pituitary Adenomas Prolactinomas |
Interventions |
Drug: Pasireotide Drug: cabergoline |
Enrollment | 21 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Pasireotide | Cabergoline |
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Non-cured patients with resistant prolactinomas, MRI will be performed immediately before and six months after the onset of pasireotide. The efficacy will be evaluated by prolactin dosage every month. Patients with a nonfunctioning pituitary adenoma (NFPA), treatment will be started at least 3 months after neurosurgery. The efficacy will be evaluated by MRI 6 months after pasireotide. Pasireotide: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at the dosage of 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months. The patients with resistant prolactinomas will be treated with pasireotide at the dosage of 600 µg s.c. twice a day. After 4 weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for 6 months. |
In patients with non-functioning pituitary adenoma, treatment will be started at least 3 months after neurosurgery. The drug response will be evaluated clinically by visual field and by Magnetic resonance imaging (MRI) before medical treatment and after six months of cabergoline treatment at maximum dose. cabergoline: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months. The patients with resistant prolactinomas will be treated with pasireotide at 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months. |
Period Title: Overall Study | ||
Started | 12 | 9 |
Completed | 6 | 9 |
Not Completed | 6 | 0 |
Reason Not Completed | ||
Withdrawal by Subject | 3 | 0 |
Lack of Efficacy | 1 | 0 |
Adverse Event | 2 | 0 |
Arm/Group Title | Pasireotide | Cabergoline | Total | |
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For non-cured patients with resistant prolactinomas , MRI will be performed before and six months after the onset of pasireotide. The efficacy will be evaluated by prolactin dosage every month. For patients harboring a NFPA, treatment will be started at least 3 months after neurosurgery. In this case, the drug efficacy will be evaluated clinically by MRI six months after pasireotide. Pasireotide: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at the dosage of 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for six months. The patients with resistant prolactinomas will be treated with pasireotide at the dosage of 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months. |
In patients with non-functioning pituitary adenoma, treatment will be started at least 3 months after neurosurgery. The drug response will be evaluated clinically by visual field and by Magnetic resonance imaging (MRI) before medical treatment and after six months of cabergoline treatment at maximum dose. cabergoline: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months. The patients with resistant prolactinomas will be treated with pasireotide at 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 12 | 9 | 21 | |
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[Not Specified]
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 12 participants | 9 participants | 21 participants | |
33
(24 to 63)
|
54
(36 to 65)
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54
(24 to 65)
|
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 12 participants | 9 participants | 21 participants | |
Female |
8 66.7%
|
5 55.6%
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13 61.9%
|
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Male |
4 33.3%
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4 44.4%
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8 38.1%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Brazil | Number Analyzed | 12 participants | 9 participants | 21 participants |
12 | 9 | 21 |
Name/Title: | Monica Gadelha |
Organization: | Universidade Federal do Rio de Janeiro |
Phone: | +552139382323 |
EMail: | mgadelha@hucff.ufrj.br |
Responsible Party: | Monica Gadelha, Universidade Federal do Rio de Janeiro |
ClinicalTrials.gov Identifier: | NCT01620138 |
Other Study ID Numbers: |
CSOM230BBR01T |
First Submitted: | September 18, 2011 |
First Posted: | June 15, 2012 |
Results First Submitted: | June 1, 2015 |
Results First Posted: | June 16, 2016 |
Last Update Posted: | August 22, 2016 |