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Oestrogen Withdrawal in Hypopituitary Women

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00572390
First received: December 11, 2007
Last updated: December 12, 2007
Last verified: December 2007
History of Changes
  Purpose

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


Condition Intervention
Hypopituitarism
 Drug: oestrogen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Oestrogen Withdrawal in Hypopituitary Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • androgens, IGF-I, body composition, liver enzymes, [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Grehlin, adiponection, leptin [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: January 2001
Study Completion Date: February 2002
Arms Assigned Interventions
Placebo Comparator: 1
No oestrogen treatment
 Drug: oestrogen
Cyclic oestrogen substitution therapy
Experimental: 2
Oestrogen treatment
 Drug: oestrogen
Cyclic oestrogen substitution therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Hypopituitarism
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Aarhus

Additional 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
Study First Received: December 11, 2007
Last Updated: December 12, 2007
Health Authority: Denmark: Danish Dataprotection Agency

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013