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Oestrogen Withdrawal in Hypopituitary Women

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ClinicalTrials.gov Identifier: NCT00572390
Recruitment Status : Completed
First Posted : December 13, 2007
Last Update Posted : December 13, 2007
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment
Hypopituitarism Drug: oestrogen

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Oestrogen Withdrawal in Hypopituitary Women
Study Start Date : January 2001
Study Completion Date : February 2002


Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: 1
No oestrogen treatment
Drug: oestrogen
Cyclic oestrogen substitution therapy
Experimental: 2
Oestrogen treatment
Drug: oestrogen
Cyclic oestrogen substitution therapy


Outcome Measures

Primary Outcome Measures :
  1. androgens, IGF-I, body composition, liver enzymes, [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Grehlin, adiponection, leptin [ Time Frame: 1 month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Hypopituitarism
Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00572390


Locations
Denmark
Århus Universityhospital
Århus, Denmark, dk-8000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Jens J Christiansen, PhD Århus Universityhospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jens Sandahl Christiansen, Århus universityhospital
ClinicalTrials.gov Identifier: NCT00572390     History of Changes
Other Study ID Numbers: oestrogen withdrawal
1999/4644
First Posted: December 13, 2007    Key Record Dates
Last Update Posted: December 13, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs