Oestrogen Withdrawal in Hypopituitary Women
Primary Purpose
Hypopituitarism
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
oestrogen
Sponsored by
About this trial
This is an interventional basic science trial for Hypopituitarism
Eligibility Criteria
Inclusion Criteria:
- Hypopituitarism
Sites / Locations
- Århus Universityhospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
1
2
Arm Description
No oestrogen treatment
Oestrogen treatment
Outcomes
Primary Outcome Measures
androgens, IGF-I, body composition, liver enzymes,
Secondary Outcome Measures
Grehlin, adiponection, leptin
Full Information
NCT ID
NCT00572390
First Posted
December 11, 2007
Last Updated
December 12, 2007
Sponsor
University of Aarhus
1. Study Identification
Unique Protocol Identification Number
NCT00572390
Brief Title
Oestrogen Withdrawal in Hypopituitary Women
Official Title
Oestrogen Withdrawal in Hypopituitary Women
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
By exploring hormonal status in hypopituitary women during oestrogen treatment and without estrogen substitution the influence on sexhormones and organ function is estimated.
Detailed Description
38 hypopituitary women were examinined twice. During oestrogen treatment and after 1 month estrogen withdrawal. A control group of healthy women were examined once.Antropometric data and hormonal parameters were collected.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypopituitarism
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
No oestrogen treatment
Arm Title
2
Arm Type
Experimental
Arm Description
Oestrogen treatment
Intervention Type
Drug
Intervention Name(s)
oestrogen
Intervention Description
Cyclic oestrogen substitution therapy
Primary Outcome Measure Information:
Title
androgens, IGF-I, body composition, liver enzymes,
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Grehlin, adiponection, leptin
Time Frame
1 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Hypopituitarism
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens J Christiansen, PhD
Organizational Affiliation
Århus Universityhospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Århus Universityhospital
City
Århus
ZIP/Postal Code
dk-8000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
19660970
Citation
Host C, Christiansen JJ, Christiansen JS, Jorgensen JO, Gravholt CH. Discontinuation of hormone replacement therapy in young GH-treated hypopituitary women increases liver enzymes. Growth Horm IGF Res. 2010 Feb;20(1):26-30. doi: 10.1016/j.ghir.2009.07.001. Epub 2009 Aug 5.
Results Reference
derived
Learn more about this trial
Oestrogen Withdrawal in Hypopituitary Women
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