Recruitment

Recruitment Status
Terminated

Inclusion Criterias

The IGF-I level at screening ≤-1 SDS of the age and sex normal ranges according to the central laboratory measurements
No r-hGH replacement therapy or use of GH secretagogues for at least 9 months with any registered or investigational r-hGH or GH secretagogue product.
GHD subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II (2007).
...
The IGF-I level at screening ≤-1 SDS of the age and sex normal ranges according to the central laboratory measurements
No r-hGH replacement therapy or use of GH secretagogues for at least 9 months with any registered or investigational r-hGH or GH secretagogue product.
GHD subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II (2007).
Men and women between the age of 23 to 70 years old at screening, inclusive
Subjects who are on a stable diet and exercise regime and do not have plans to modify their diet or exercise for at least 12 months
Subject had a DXA screening and the results are interpretable according to the study plan.

Exclusion Criterias

Evidence of growth benign intracranial tumor within the last 12 months (determined by comparing a previous MRI to a new one obtained no more than 6 months prior to study entry to clarify dynamics of growth).
History of any cancer. Exceptions to this exclusion criterion include resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision. Patients with GHD attributed to treatment of intracranial malignant lesions in childhood or adulthood (or, tumors) or leukemia may also be enrolled into the study provided that a recurrence-free survival period of at least 5 years is well documented in the study record.
Women who are pregnant or breast-feeding (at least 6 months delay from childbirth or lactation)
...
Evidence of growth benign intracranial tumor within the last 12 months (determined by comparing a previous MRI to a new one obtained no more than 6 months prior to study entry to clarify dynamics of growth).
History of any cancer. Exceptions to this exclusion criterion include resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision. Patients with GHD attributed to treatment of intracranial malignant lesions in childhood or adulthood (or, tumors) or leukemia may also be enrolled into the study provided that a recurrence-free survival period of at least 5 years is well documented in the study record.
Women who are pregnant or breast-feeding (at least 6 months delay from childbirth or lactation)
History of Acromegaly
Heart insufficiency, NYHA class > 2 (Appendix B)
History of overt diabetes mellitus (including currently treated, well-controlled DM) defined according to the American Diabetes Association (ADA) Criteriaa. A history of gestational diabetes, resolved after childbirth, is not exclusionary.
Signs of intracranial hypertension at screening

Summary

Conditions
Adult Growth Hormone Deficiency
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 23 years and 70 years
Gender
Both males and females

Inclusion Criterias

The IGF-I level at screening ≤-1 SDS of the age and sex normal ranges according to the central laboratory measurements
No r-hGH replacement therapy or use of GH secretagogues for at least 9 months with any registered or investigational r-hGH or GH secretagogue product.
GHD subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II (2007).
...
The IGF-I level at screening ≤-1 SDS of the age and sex normal ranges according to the central laboratory measurements
No r-hGH replacement therapy or use of GH secretagogues for at least 9 months with any registered or investigational r-hGH or GH secretagogue product.
GHD subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II (2007).
Men and women between the age of 23 to 70 years old at screening, inclusive
Subjects who are on a stable diet and exercise regime and do not have plans to modify their diet or exercise for at least 12 months
Subject had a DXA screening and the results are interpretable according to the study plan.

Exclusion Criterias

Evidence of growth benign intracranial tumor within the last 12 months (determined by comparing a previous MRI to a new one obtained no more than 6 months prior to study entry to clarify dynamics of growth).
History of any cancer. Exceptions to this exclusion criterion include resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision. Patients with GHD attributed to treatment of intracranial malignant lesions in childhood or adulthood (or, tumors) or leukemia may also be enrolled into the study provided that a recurrence-free survival period of at least 5 years is well documented in the study record.
Women who are pregnant or breast-feeding (at least 6 months delay from childbirth or lactation)
...
Evidence of growth benign intracranial tumor within the last 12 months (determined by comparing a previous MRI to a new one obtained no more than 6 months prior to study entry to clarify dynamics of growth).
History of any cancer. Exceptions to this exclusion criterion include resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision. Patients with GHD attributed to treatment of intracranial malignant lesions in childhood or adulthood (or, tumors) or leukemia may also be enrolled into the study provided that a recurrence-free survival period of at least 5 years is well documented in the study record.
Women who are pregnant or breast-feeding (at least 6 months delay from childbirth or lactation)
History of Acromegaly
Heart insufficiency, NYHA class > 2 (Appendix B)
History of overt diabetes mellitus (including currently treated, well-controlled DM) defined according to the American Diabetes Association (ADA) Criteriaa. A history of gestational diabetes, resolved after childbirth, is not exclusionary.
Signs of intracranial hypertension at screening

Locations

Kiryat Gat, 8211804
Kiryat Gat, 8211804

Tracking Information

NCT #
NCT01909479
Collaborators
Not Provided
Investigators
Not Provided