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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Patients with non-functioning pituitary tumours: Are there differences between gender in post-operative hormone outcomes and does this relate to the pressure within the tumours?
Scientific title
Participants with non-functioning pituitary macroadenomas: Intrasellar pressure measurement at the time of operation and pituitary hormone deficiencies. Do gender differences exist?
Secondary ID [1] 281215 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non functioning pituitary adenomas 287405 0
Hormone Deficiencies 287406 0
Condition category
Condition code
Neurological 287733 287733 0 0
Other neurological disorders
Metabolic and Endocrine 287734 287734 0 0
Other metabolic disorders

Study type
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1) Observational data of hormone deficiencies pre and 6 months post operatively for surgically treated non functioning pituitary adenomas.
2) Measurement of pressure within the pituitary adenoma at the time of surgery
3) Quality of life questionnaire pre and 6 months post surgery
Intervention code [1] 285682 0
Not applicable
Comparator / control treatment
No camparator or control group
Control group

Primary outcome [1] 287973 0
That Premenopausal females have fewer hormone deficiencies compared to males and postmenopausal females post-operatively for treatment of non functioning pituitary macroadenomas. This will be assessed by the collection of biochemical hormone blood test. The hormonal assessment is routine part of clinical management of this condition. We aim to collect this data.
Timepoint [1] 287973 0
6 months post surgery
Secondary outcome [1] 299164 0
That Intrasellar pressure measured at the time of operation is lower in premenopausal females compared to males and postmenopausal females. This measurement of intrasellar pressure will be measured at the time of surgery using a commercial kit - Codman Intracranial Pressure Monitoring Kit (Camino Laboratories San Diego CA). At surgery, dura is exposed by removal of the bony sella floor, and a 1.5mm dural opening made allowing insertion of the fiberoptic transducer tip into the pituitary tumour with minimal chance of tumour extravasation. When a stable waveform is present on the pressure monitor, mean ISP is recorded and the catheter removed, with surgery proceeding as usual. This procedure will take 3-5 minutes.
Timepoint [1] 299164 0
Measured at the time of surgery
Secondary outcome [2] 299190 0
The measurement of Quality of life of participants pre and 6 month post surgery: that quality of life remains unchanged. This will be undertaken by a a validated questionnaire SF36- 4 week recall. Participants will undertake the questionnaire pre-operatively and 6 months post-peratively, with each participant acting as their own control
Timepoint [2] 299190 0
Pre-operatively and 6 months post-operatively

Key inclusion criteria
All adult patients who require surgery for non functioning pituitary adenomas having surgery at the study hospitals will be eligible for inclusion in the study.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Inability to give consent

Study design
Natural history
Defined population
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285993 0
Name [1] 285993 0
St Vincent's Hospital, Melbourne
Address [1] 285993 0
35 Victoria Parade
Fitzroy, 3065,
Country [1] 285993 0
Primary sponsor type
Carmela Caputo
St Vincent's Hospital,
35 Victoria Parade, Fitzroy, 3065
Secondary sponsor category [1] 284812 0
Name [1] 284812 0
Address [1] 284812 0
Country [1] 284812 0

Ethics approval
Ethics application status
Ethics committee name [1] 288040 0
St Vincents Hospital Research and Ethics
Ethics committee address [1] 288040 0
Ethics committee country [1] 288040 0
Date submitted for ethics approval [1] 288040 0
Approval date [1] 288040 0
Ethics approval number [1] 288040 0
HREC-A 028/12

Brief summary
The pituitary gland is an important gland that assists in control and release of hormones in the body. Abnormal growths in the gland, called “pituitary tumours or adenomas” can occur. The most frequent type requiring surgery is the non-functioning pituitary macroadenoma (NFPMA), which are tumours that don’t produce any excessive hormones but can be associated with hormone deficiences.
At St Vincent’s Hospital, we have reviewed our own historical series of NFPMA. Between 1995 and 2010, 141 cases of NFPMA were operated on. It was observed that males were more likely than females to be to have 2 or more hormonal deficiencies at presentation. Post-operatively, 2 or more hormone deficiencies occurred more frequently in males and postmenopausal females but rarely in premenopausal females. So it appears that premenopausal females to have better hormonal outcomes.
We have hypothesed that it may be related to lower pressure within tumours of premenopausal females. High pressure in the tumour is postulated to reduce blood flow to the pituitary gland and leads to death of normal hormone producing cells, thus less ability for hormonal recovery.
This current project has been designed to confirm if gender differences in hormone deficiencies do occur after surgery. Also to demonstrate that pressure within tumours of premenopausal females in lower than males and postmenopausal females.
These findings are important as they contribute to the understanding of hormonal differences in genders, which has not been fully examined before.
Trial website
Trial related presentations / publications
Clin Endocrinol (Oxf). 2012 Aug 13. doi: 10.1111/cen.12009. [Epub ahead of print]

Gender differences in presentation and outcome of non-functioning pituitary macroadenomas.

Caputo C, Sutherland T, Farish S, McNeill P, Ng KW, Inder WJ.
Public notes

Principal investigator
Name 34702 0
Dr Carmela Caputo
Address 34702 0
St Vincent's Hospital Melbourne,
4th Floor Daly Wing
Department Endocrinology and Diabetes
35 Victoria Parade,
Fitzroy 3065
Country 34702 0
Phone 34702 0
+61 3 9288 2211
Fax 34702 0
Email 34702 0
Contact person for public queries
Name 17949 0
Dr Carmela Caputo
Address 17949 0
4th Floor Daly Wing
Department of Endocrinology
St Vincent's Hospital,
35 Victoria Parade, Fitzroy, 3065
Country 17949 0
Phone 17949 0
+61 3 9288 3579
Fax 17949 0
+61 3 9288 3590
Email 17949 0
Contact person for scientific queries
Name 8877 0
Dr Carmela Caputo
Address 8877 0
4th Floor Daly Wing
Department of Endocrinology
St Vincent's Hospital,
35 Victoria Parade, Fitzroy, 3065
Country 8877 0
Phone 8877 0
+61 3 9288 3579
Fax 8877 0
+61 3 9288 3590
Email 8877 0

No information has been provided regarding IPD availability
Summary results
No Results