Effects of Estrogen on Muscle Gain During 12-weeks of Exercise in Post-menopausal Women

NCT07617454 | Recruiting

• 1 other identifier: E30 HER-MUSCLE Intervention
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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:

1. 1.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.
2. 2.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.
3. 3.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.

Conditions

Menopause Related Conditions; Exercise Training

Keywords

Physical exercise; Strength training; Cardiovascular training; Muscle hypertrophy; Estrogen; Mitochondria function; Muscle strength; Menopause; Muscle mass

Outcome Measures

Primary Outcomes (1)

• Muscle mass

  Magnetic resonance imaging of one leg before and after intervention

  12 weeks

Secondary Outcomes (19)

• Mitochondria Function in vivo measured as phosphocreatine recovery rate

  12 weeks

• Mitochondria Function in vitro measured as maximal oxygen consumption

  12 weeks

• Body composition

  12 weeks

• Satelitte cells

  12 weeks

• Muscle fiber cross-sectional Area

  12 weeks

Other Outcomes (4)

• Blood analysis

  12 weeks

• Dairy record registration

  12 weeks

• Height

  12 weeks

Study Arms (2)

Estrogen

EXPERIMENTAL

Transdermal Estrogen Administration

Drug: Estrogel; Behavioral: Physical exercise

Placebo

PLACEBO COMPARATOR

Transdermal placebo administration

Behavioral: Physical exercise

Interventions

Estrogel DRUG

The other group receive placebo treatment

Estrogen

Physical exercise BEHAVIORAL

Both groups will go through 12 weeks of supervised physical exercise, consisting of both strength training and cardiovascular training

Estrogen; Placebo

Eligibility Criteria

• Age: 40 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years since last menstrual bleeding
• Age \> 40 years old
• BMI 20-30

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Aalborg University: collaborator
• University of Copenhagen: collaborator
• Aarhus University Hospital: collaborator
• Mette Hansen: lead

Study Sites (1)

Aarhus University

Aarhus, Jutland, 8000, Denmark

RECRUITING

Related Links

• Project homepage

MeSH Terms

Conditions

Motor Activity

Interventions

Estradiol; Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mette Hansen, PhD

  Aarhus University, Department of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mette Hansen, PhD

CONTACT

+4551666551; mhan@ph.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: June 1, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)