Oestrogen Withdrawal in Hypopituitary Women | NCT00572390

Studies
Oestrogen Withdrawal in Hypopituitary Women

NCT00572390

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Dec 13, 2007Estimated

Enrollment

38Actual

Phase

Not Applicable

Conditions

Hypopituitarism

Interventions

oestrogen

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1999/4644

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2001

Primary Completion Date

Not provided

Completion Date

Feb 2002Actual

First Submitted Date

Dec 11, 2007

First Submission Date that Met QC Criteria

Dec 12, 2007

First Posted Date

Dec 13, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2007

Last Update Posted Date

Dec 13, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator	No oestrogen treatment	Drug: oestrogen
2	Experimental	Oestrogen treatment	Drug: oestrogen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oestrogen	Drug	Cyclic oestrogen substitution therapy	1 2

Measure	Description	Time Frame
androgens, IGF-I, body composition, liver enzymes,		1 month

Measure	Description	Time Frame
Grehlin, adiponection, leptin		1 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hypopituitarism

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jens J Christiansen, PhD	Århus Universityhospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Århus Universityhospital		Aarhus		dk-8000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19660970	Derived	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.

ID	Term
D010900	Pituitary Diseases
D007027	Hypothalamic Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions