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CompletedNCT03020953ESTROUpdated Sep 27, 2019

The Anabolic Effects of Estrogen on Skeletal Muscles

An interventional study of Exercise + Estrogen and Exercise + Placebo in Estrogen Supplementation, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to female participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-27.

Sponsored by University of Aarhus · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
40 Years and older
Sex
Female
01

Study summary

Purpose: to study the effect of estrogen replacement on muscle hypertrophy in response to 12 weeks resistance training in postmenopausal women Hypothesis: Transdermal administration of 17-β estradiol enhance the anabolic effect of resistance training on muscle mass, strength in postmenopausal women Primary outcome: Muscle hypertrophy (muscle CSA, muscle fiber type specific CSA) Secondary outcome: Messenger RiboNucleic Acid (mRNA)(real-time PCR), protein (western blotting), satellite cell proliferation and activation, Strength, functional test, muscle protein synthese.

Design: Two groups of healthy postmenopausal women (½-5 years after menopause) who have not performed regular resistance exercise (\<1 times per week) the last two years. Randomized, controlled intervention study +/- transdermal administration of estrogen (17-β estradiol). Both groups perform 12 weeks of supervised progressive resistance training (3/week) aiming to induce muscle hypertrophy in the legs.

02

Conditions studied

  • Estrogen Supplementation
03

In context

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Postmenopausal women, more than 6 months, but less than 5 years since last menstruation.

Exclusion criteria

Exclusion Criteria:

  • Less than 2 hours exercise with moderate to high intensity per week the last year, no regular resistance exercise the last 2 years (less than 5 exercise bouts during the last year)
  • No previous or present lower limb injuries which may hinder participation in strength training
  • No use of medicine which may influence the adaptation to strength training such as regular use of nonsteroidal anti-inflammatory drugs and use of statins, no muscle
  • Joint or metabolic diseases or other chronic diseases that would affect the results of the investigation, high blood pressure (>140/90), smoking
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Exercise + Estrogen

    Strength training 3 times a week for 12 weeks. Estrogen patches which provide 100 um pr. 24 hours.

    Other: Exercise + Estrogen

  • Active comparator
    Exercise + Placebo

    Strength training 3 times a week for 12 weeks. Placebo patches.

    Other: Exercise + Placebo

Interventions

  • OtherExercise + Estrogen

    12 weeks resistance training and estrogen patches

  • OtherExercise + Placebo

    12 weeks resistance training and placebo patches

06

What researchers measure

Primary outcomes

  1. Muscle hypertrophy

    muscle cross sectional area measured by Magnetic resonance imaging (MR) -scans

    Time frame: 12 weeks

Secondary outcomes

  1. Muscle fiber hypertrophy

    Histology analysis of muscle fiber area

    Time frame: 12 weeks

  2. Muscle strength

    Maximal isometric muscle strength

    Time frame: 12 weeks

  3. tendon size

    Tendon cross sectional area measured by MR-scan

    Time frame: 12 weeks

  4. Fat cell size

    Analysis of fat cell size (diameter)

    Time frame: 12 weeks

  5. Fat mass

    Dual-energy X-ray absorptiometry (DXA) scan of total fat mass

    Time frame: 12 weeks

  6. Fat free mass

    Fat free mass measured by DXA scan

    Time frame: 12 weeks

07

Study locations

1 site
  • Sport Science, Department of Public Health, Aarhus University
    Aarhus, 8000, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03020953
Lead sponsor
University of Aarhus
Responsible party
Sponsor
First posted
Jan 13, 2017
Start date
Jan 1, 2017
Primary completion
Feb 15, 2018
Completion
Feb 15, 2018
Last update
Sep 27, 2019

Study contacts

Mette Hansen, PhD
principal investigator · University of Aarhus

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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