A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency
Sponsored by Novo Nordisk A/S
About this trial
Last updated 5 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 10 years ago
What is this trial about?
What are the Participation Requirements?
Inclusion Criteria: - Male or female of at least 18 years of age and not more than 79
years of age at the time of signing informed consent - Adult growth hormone deficiency
diagnosed for 6 months or longer (defined as 180 days) prior to screening - Treatment
with hGH (human growth hormone) for at least 6 months at screening - If applicable,
hormone replacement therapies for any other hormone deficiencies, adequate and stable for
at least 90 days prior to randomisation as judged by the investigator Exclusion Criteria:
- Active malignant disease or history of malignancy. Exceptions to this exclusion
criterion: Resected in situ carcinoma of the cervix and squamous cell or basal cell
carcinoma of the skin with complete local excision. / Subjects with GHD (growth hormone
deficiency) attributed to treatment of intracranial malignant tumours or leukaemia,
provided that a recurrence-free survival period of at least 5 years is documented in the
subject's file - For patients with surgical removal or debulking of pituitary adenoma or
other benign intracranial tumour within the last 5 years: Evidence of growth of pituitary
adenoma or other benign intracranial tumour within the last 12 months (defined as below
or equal to 365 days) before randomisation. Absence of growth must be documented by two
post-surgery MRI or CT scans. The most recent MRI or CT scan must be performed below or
equal to 9 months (defined as below or equal to 270 days) prior to randomisation