Menopause Related ConditionsHER-MUSCLENCT07617454
Effects of Estrogen on Muscle Gain During 12-weeks of Exercise in Post-menopausal Women
A study testing Estrogel and Physical exercise in people with Menopause Related Conditions and Exercise Training, run by Mette Hansen at 1 site in Denmark.
Trial summary
As females age and transition through menopause, the decline in oestrogen level profoundly affects skeletal muscle mass and function. HER-MUSCLE aims to unravel the mechanisms by which oestrogen enhances muscle growth, providing insights for targeted therapies to improve the health and physical function of… 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
- Menopause Related Conditions, Exercise Training
- What is being tested?
- Estrogel and Physical exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2026to 1 Aug 2027
- Phase
- Interventional
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
- 1-10 years since last menstrual bleeding
- Age > 40 years old
- BMI 20-30
Who cannot join
- Follicular stimulating hormone < 30 mmol/L
- Systematic strength training during the last year (> 1 strength training session per week)
- Injuries to the legs which may prevent participation in the physical training program
- Magnetizable metals or electrical devices implanted in the body, such as a pacemaker
- Use of medication that can influence the effect of immobilization and/or training
- Muscular or joint disorders which may affect the results
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- Metabolic diseases (such as diabetes and cardiovascular diseases)
- Previous or present liver or cancer disease
- Current or previous thrombosis
- Porphyria
- Epilepsia
- Systemic autoimmune disease
- Edema
- Smoking or use of other nicotine containing products
- Claustrophobia
- Addictive behavior, defined as abuse of cannabis, opioids, or other intoxicating substances.
- Lack of ability to cooperate
- Blood parameters out of normal range at the health check
- Blood pressure above 140/90 mmHg
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University
Aarhus, Jutland, 8000
Mette Hansen, PhD, +4551666551, mhan@ph.au.dk
About this study
As females age and transition through menopause, the decline in oestrogen level profoundly affects skeletal muscle mass and function. HER-MUSCLE aims to unravel the mechanisms by which oestrogen enhances muscle growth, providing insights for targeted therapies to improve the health and physical function of postmenopausal females.
Focusing on postmenopausal females, an increasingly at-risk demographic, HER-MUSCLE addresses a critical gap in understanding how oestrogen influences muscle mass and function during anabolic (exercise) conditions.
Read more
The project involves:
- Clinical Trial: Postmenopausal females will receive either oestrogen or placebo, twelve weeks of exercise training to detect oestrogen regulatory role on muscle mass and function.
- Molecular Analysis: Advanced techniques will study the muscle microenvironment, focusing on muscle stem cells (MuSCs), fibro-adipogenic progenitors (FAPs), and other cells critical for muscle regeneration and maintenance.
- Mitochondrial Function assessed in vivo via magnetic resonance spectroscopy: The impact of oestrogen on mitochondrial health will be examined, exploring how it preserves mitochondrial function and ability to recovery and resist fatigue in response to muscle contractions.
Our preliminary data indicate that oestrogen can promote muscle protein synthesis. HER-MUSCLE aims to pave the way for novel therapeutic strategies to manage sarcopenia in postmenopausal women, ultimately leading to better health outcomes and enhanced well-being for this growing population segment.
Read the detailed description
As females age and transition through menopause, the decline in oestrogen level profoundly affects skeletal muscle mass and function. HER-MUSCLE aims to unravel the mechanisms by which oestrogen enhances muscle growth, providing insights for targeted therapies to improve the health and physical function of postmenopausal females.
Focusing on postmenopausal females, an increasingly at-risk demographic, HER-MUSCLE addresses a critical gap in understanding how oestrogen influences muscle mass and function during anabolic (exercise) conditions.
The project involves:
- Clinical Trial: Postmenopausal females will receive either oestrogen or placebo, twelve weeks of exercise training to detect oestrogen regulatory role on muscle mass and function.
- Molecular Analysis: Advanced techniques will study the muscle microenvironment, focusing on muscle stem cells (MuSCs), fibro-adipogenic progenitors (FAPs), and other cells critical for muscle regeneration and maintenance.
- Mitochondrial Function assessed in vivo via magnetic resonance spectroscopy: The impact of oestrogen on mitochondrial health will be examined, exploring how it preserves mitochondrial function and ability to recovery and resist fatigue in response to muscle contractions.
Our preliminary data indicate that oestrogen can promote muscle protein synthesis. HER-MUSCLE aims to pave the way for novel therapeutic strategies to manage sarcopenia in postmenopausal women, ultimately leading to better health outcomes and enhanced well-being for this growing population segment.
- Conditions
- Menopause Related Conditions, Exercise Training
- Being tested
- Estrogel, Physical exercise
- Keywords
- Physical exercise, Strength training, Cardiovascular training, Muscle hypertrophy, Estrogen, Mitochondria function, Muscle strength, Menopause, Muscle mass
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstrogelDrug
The other group receive placebo treatment
Physical exerciseBehavioural
Both groups will go through 12 weeks of supervised physical exercise, consisting of both strength training and cardiovascular training
| Study group | Role | What they receive |
|---|---|---|
| Estrogen | Experimental | Transdermal Estrogen Administration Receives: Drug: Estrogel; Behavioral: Physical exercise |
| Placebo | Placebo comparator | Transdermal placebo administration Receives: Behavioral: Physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass
Magnetic resonance imaging of one leg before and after intervention
Measured: 12 weeks
Secondary outcomes (19)
Mitochondria Function in vivo measured as phosphocreatine recovery rate
The dominant foot will be attached to a pedal mounted on the patient bed and a dedicated 31P surface coil will be secured over the tibialis anterior muscle. The pedal is designed to allow dynamic contractions of the tibialis anterior muscle while changes in metabolites from the tibialis anterior muscle are acquired non-invasively with the 31P coil. Two protocols will be performed: Firstly, 10 repeated contractions (one per 3 sec with a load representing 30% of maximal force) will result in a depletion (30-40%) of phosphocreatine (PCr). The rate constant for PCr recovery over 10 min will be used as an index of in vivo mitochondrial function. Secondly, a total of 80 repeated contractions (one per 3 sec with a load representing 30% of maximal force) will be used to quantify muscle fatigue and concurrent changes in muscle metabolites and intracellular pH (based on the chemical shift between inorganic phosphate and PCr).
Measured: 12 weeks
Mitochondria Function in vitro measured as maximal oxygen consumption
All measurements were performed in duplicate using an Oxygraph-2k (Oroboros, Austria), in hyperoxygenated chambers (250-450 nmol O₂/mL).
Respiratory Control Ratio was used to evaluate mitochondrial efficiency. It was calculated as the ratio of maximal ADP-supported respiration (with complex I + II substrates) to leak respiration. Leak respiration reflects oxygen consumption in the absence of ATP synthesis, when only substrates are present and no ADP is added.
Measured: 12 weeks
Body composition
DXA
Measured: 12 weeks
Satelitte cells
Histochemical Analysis of Muscle tisse
Measured: 12 weeks
Muscle fiber cross-sectional Area
Histochemical Analysis of Muscle Tissue
Measured: 12 weeks
Expression of Muscle proteins
Western blotting analysis
Measured: 12 weeks
FACS Analysis
FACS analysis to quantify and isolate Muscle satelitte celss, fibro-adipogenic progenitors and macrofages
Measured: 12 weeks
Muscle Strength
Includes measure of leg strength during isometric and dynamic maximal voluntary contractions in a dynamometer (Humac Norm, CSMi, Massachusetts, United States) with a hip angle of 90°. In addition, finger strength, hand grip strength
Measured: 12 weeks
Functional test
Includes counter-movement jump on a speed force-platform (Swift performance, Australia). To measure dexterity, the nine-hole peg test will be applied.
Measured: 12 weeks
Cardiovascular fitness
Vo2max test on a bike and estimated via Ventriject
Measured: 12 weeks
Maximal fat oxidation rate
Bike test with increasing intensity steps
Measured: 12 weeks
Resisting metabolic rate
Measured: 12 weeks
Questionaires
The participant will be asked to fill out recognized questionnaires about menopause (Menopause Rating Scale), sleep, diet and training readiness (modified version of "The wellbeing review"
Measured: 12 weeks
Physical Activity Level
Accelerometers
Measured: 12 weeks
Flexibility
sit-and-reach test
Measured: 12 weeks
Knee laxity
Lachmeter test
Measured: 12 weeks
Protein expression in adipose tissue
Two adipose tissue biopsies will be obtained from each participant by a trained physician before and after 12 weeks from subcutaneous abdominal and gluteal regions. Western blotting analysis of expression of proteins related to lipolysis and lipogenesis
Measured: 12 weeks
Blood pressure
Measured: 12 weeks
Blood volume
Determination of blood volume and haemoglobin mass by the carbon-monoxide rebreathing method
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 posted1 Jun 2026
- Study start1 Feb 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopause Related ConditionsStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a model study where we manipulate with the estrogen level to study the consequences of low versus high estrogen status on physiological parameters during 12 weeks of physical exercise
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mette Hansen
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University, University of Copenhagen, Aarhus University Hospital
- Responsible party
- Sponsor-investigator, Mette Hansen, University of Aarhus
- Investigators
- Mette Hansen, PhD, Principal investigator, Aarhus University, Department of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617454
- Sponsor's protocol ID
- E30 HER-MUSCLE Intervention
- Acronym
- HER-MUSCLE
- Status last verified
- May 2026
- First submitted
- 27 Feb 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Do to GDPR rules, we do not plan to share