NCT00435175

Brief Summary

Estradiol promotes and maintains the typical female phenotype characterized by subcutaneous fat accumulation. There is evidence to suggest that this effect relies on the ability of estradiol to increase the amount of anti-lipolytic α2A-adrenergic receptors, but whether this requires long-term exposure to estradiol or is the result of an immediate effect is not clear. Objective: To study acute effects of a single dose (4 mg) of 17β-estradiol on regional and systemic lipolysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2005

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

June 1, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 14, 2007

Completed
Last Updated

February 14, 2007

Status Verified

February 1, 2007

First QC Date

February 13, 2007

Last Update Submit

February 13, 2007

Conditions

Postmenopause

Keywords

EstradiolLipolysisEstrogen receptorAdrenergic receptorsUCP2Postmenopausal women

Outcome Measures

Primary Outcomes (4)

  • Regional lipolysis assessed by microdialysis

  • Systemic lipolysis assessed by the isotope dilution technique

  • Lipoprotein lipase activity

  • Adrenergic receptor mRNA expression

Secondary Outcomes (2)

  • Estrogen receptor mRNA expression

  • UCP2 mRNA expression

Interventions

estradiolDRUG

Eligibility Criteria

Age45 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women assessed by FSH and estradiol levels
  • Not taking any drugs
  • Non-smokers

You may not qualify if:

  • Obesity (BMI\>30)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Research Laboratories

Aarhus, 8000, Denmark

Location

MeSH Terms

Interventions

Estradiol

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Lars C Gormsen, MD

    Aarhus University, Clinical Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 13, 2007

First Posted

February 14, 2007

Study Start

June 1, 2005

Study Completion

July 1, 2006

Last Updated

February 14, 2007

Record last verified: 2007-02

Locations

DK(1)