To provide medical follow-up to patients exposed to BGG492 for more than 28 days in study CBGG492A2207 (NCT 01147003) and/or CBGG492A2212 (NCT 01338805).
The purpose of the study was to provide medical follow-up to patients exposed to BGG492 for more than 28 days in study CBGG492A2207 (NCT 01147003) and/or CBGG492A2212 (NCT 01338805). Data from study CBGG492A2216 was used to support the clinical safety assessment of BGG492 regarding the observance of uterine endometrial stromal tumors and adrenal cortical adenomas at least one year after the completion of BGG492 treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
59
MRI/CT/ultrasound of abdomen
Low dose of dexamethasone is administered in the evening; the next morning, a blood sample is collected to measure cortisol
Sonogram of the uterus (females only)
Novartis Investigative Site
Tallahassee, Florida, United States
Novartis Investigative Site
Baltimore, Maryland, United States
Incidence of Adrenal Cortical Adenomas
Incidence of adrenal cortical adenomas as assessed by non-contrast MRI of the abdomen (CT or ultrasound of the abdomen was permitted if MRI was contraindication)
Time frame: Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212
Incidence of Uterine Endometrial Stromal Sarcomas
Incidence of uterine endometrial stromal sarcomas as assessed by sonogram/biopsy (females)
Time frame: Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212
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Uterine endometrial biopsy (females only)
No study-drug was administered in this study
Novartis Investigative Site
Hoffman, New Jersey, United States
Novartis Investigative Site
Dallas, Texas, United States
Novartis Investigative Site
Bernau, Germany
Novartis Investigative Site
Bielefeld, Germany
Novartis Investigative Site
Bonn, Germany
Novartis Investigative Site
Kehl-Kork, Germany
Novartis Investigative Site
Ulm, Germany
Novartis Investigative Site
Budapest, Hungary
...and 10 more locations