Estrogen SupplementationESTRONCT03020953
The Anabolic Effects of Estrogen on Skeletal Muscles
A study testing Exercise + Estrogen in people with Estrogen Supplementation, run by University of Aarhus at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Estrogen Supplementation
- What is being tested?
- Exercise + Estrogen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2017to 15 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women, more than 6 months, but less than 5 years since last menstruation.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Sport Science, Department of Public Health, Aarhus University
Aarhus, 8000
About this study
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.
- Conditions
- Estrogen Supplementation
- Being tested
- Exercise + Estrogen, Exercise + Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise + EstrogenOther
12 weeks resistance training and estrogen patches
Exercise + PlaceboOther
12 weeks resistance training and placebo patches
| Study group | Role | What they receive |
|---|---|---|
| Exercise + Estrogen | Experimental | Strength training 3 times a week for 12 weeks. Estrogen patches which provide 100 um pr. 24 hours. Receives: Other: Exercise + Estrogen |
| Exercise + Placebo | Active comparator | Strength training 3 times a week for 12 weeks. Placebo patches. Receives: Other: Exercise + Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle hypertrophy
muscle cross sectional area measured by Magnetic resonance imaging (MR) -scans
Measured: 12 weeks
Secondary outcomes (6)
Muscle fiber hypertrophy
Histology analysis of muscle fiber area
Measured: 12 weeks
Muscle strength
Maximal isometric muscle strength
Measured: 12 weeks
tendon size
Tendon cross sectional area measured by MR-scan
Measured: 12 weeks
Fat cell size
Analysis of fat cell size (diameter)
Measured: 12 weeks
Fat mass
Dual-energy X-ray absorptiometry (DXA) scan of total fat mass
Measured: 12 weeks
Fat free mass
Fat free mass measured by DXA scan
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study start1 Jan 2017
- Primary completion15 Feb 2018
- Study completion15 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Estrogen SupplementationStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mette Hansen, PhD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020953
- Sponsor's protocol ID
- Estrogen2016
- Acronym
- ESTRO
- Status last verified
- Jun 2018
- First submitted
- 15 Dec 2016
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dam TV, Dalgaard LB, Johansen FT, Bengtsen MB, Mose M, Lauritsen KM, Gravholt CH, Hansen M. Effects of transdermal estrogen therapy on satellite cell number and molecular markers for muscle hypertrophy in response to resistance training in early postmenopausal women. Eur J Appl Physiol. 2023 Mar;123(3):667-681. doi: 10.1007/s00421-022-05093-0. Epub 2022 Dec 31.
PubMed 36585491
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Anabolic Effects of Estrogen on Skeletal Muscles
- ClinicalTrials.gov ID
- NCT03020953
- Acronym / sponsor ID
- ESTRO / Estrogen2016
- Conditions
- Estrogen Supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise + Estrogen | Experimental | Other: Exercise + EstrogenStrength training 3 times a week for 12 weeks. Estrogen patches which provide 100 um pr. 24 hours. |
| Exercise + Placebo | Active comparator | Other: Exercise + PlaceboStrength training 3 times a week for 12 weeks. Placebo patches. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postmenopausal women, more than 6 months, but less than 5 years since last menstruation.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise + Estrogen12 weeks resistance training and estrogen patches | Other | Exercise + Estrogen |
| Exercise + Placebo12 weeks resistance training and placebo patches | Other | Exercise + Placebo |
Primary outcome
Muscle hypertrophy
Time frame: 12 weeks
muscle cross sectional area measured by Magnetic resonance imaging (MR) -scans
6 secondary outcomes
Muscle fiber hypertrophy
Time frame: 12 weeks
Muscle strength
Time frame: 12 weeks
tendon size
Time frame: 12 weeks
Fat cell size
Time frame: 12 weeks
Fat mass
Time frame: 12 weeks
Fat free mass
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Derived from this study: PubMed 36585491Dam TV, Dalgaard LB, Johansen FT, Bengtsen MB, Mose M, Lauritsen KM, Gravholt CH, Hansen M. Effects of transdermal estrogen therapy on satellite cell number and molecular markers for muscle hypertrophy in response to resistance training in early postmenopausal women. Eur J Appl Physiol. 2023 Mar;123(3):667-681. doi: 10.1007/s00421-022-05093-0. Epub 2022 Dec 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mette Hansen, PhD principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise + Estrogen in people with Estrogen Supplementation, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle hypertrophy (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03020953, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.