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Oestrogen Withdrawal in Hypopituitary Women

Primary Purpose

Hypopituitarism

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
oestrogen
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypopituitarism

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

First Posted
December 11, 2007
Last Updated
December 12, 2007
Sponsor
University of Aarhus
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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

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Oestrogen Withdrawal in Hypopituitary Women

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