NCT00572390

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2002

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2007

Completed
Last Updated

December 13, 2007

Status Verified

December 1, 2007

First QC Date

December 11, 2007

Last Update Submit

December 12, 2007

Conditions

Hypopituitarism

Outcome Measures

Primary Outcomes (1)

  • androgens, IGF-I, body composition, liver enzymes,

    1 month

Secondary Outcomes (1)

  • Grehlin, adiponection, leptin

    1 month

Study Arms (2)

1

PLACEBO COMPARATOR

No oestrogen treatment

Drug: oestrogen

2

EXPERIMENTAL

Oestrogen treatment

Drug: oestrogen

Interventions

oestrogenDRUG

Cyclic oestrogen substitution therapy

12

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Hypopituitarism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Århus Universityhospital

Aarhus, dk-8000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 19660970DERIVED

MeSH Terms

Conditions

Hypopituitarism

Interventions

Estrogens

Condition Hierarchy (Ancestors)

Pituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Jens J Christiansen, PhD

    Århus Universityhospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 11, 2007

First Posted

December 13, 2007

Study Start

January 1, 2001

Study Completion

February 1, 2002

Last Updated

December 13, 2007

Record last verified: 2007-12

Locations

DK(1)