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NCT00572390 Clinical Trial

Oestrogen Withdrawal in Hypopituitary Women

Hypopituitarism Clinical Trial

Official title:
Oestrogen Withdrawal in Hypopituitary Women

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00572390
Other study ID # oestrogen withdrawal
Secondary ID 1999/4644
Status Completed
Phase N/A
First received December 11, 2007
Last updated December 12, 2007
Start date January 2001
Est. completion date February 2002

Study information
Verified date December 2007
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial Summary

By exploring hormonal status in hypopituitary women during oestrogen treatment and without estrogen substitution the influence on sexhormones and organ function is estimated.

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.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date February 2002
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Hypopituitarism

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• oestrogen
Cyclic oestrogen substitution therapy

Locations
Country Name City State
Denmark Århus Universityhospital Århus

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary androgens, IGF-I, body composition, liver enzymes, 1 month No
Secondary Grehlin, adiponection, leptin 1 month No
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