NCT07649356

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 differences in pre and post menopausal women, in regards to muscle size, strength and function. Focusing on postmenopausal females, an increasingly at-risk demographic, HER-MUSCLE addresses a critical gap in understanding how oestrogen influences muscle mass and function. The project involves:

  1. 1.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.
  2. 2.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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
12mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress35%
Feb 2026Aug 2027

Study Start

First participant enrolled

February 1, 2026

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 16, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

June 16, 2026

Status Verified

June 1, 2026

Enrollment Period

1.5 years

First QC Date

February 27, 2026

Last Update Submit

June 9, 2026

Conditions

Keywords

Muslce MassMuscle StrengthMenopauseEstrogenMitochondria function

Outcome Measures

Primary Outcomes (1)

  • Muscle mass

    Magnetic resonance imaging

    1 week

Secondary Outcomes (19)

  • Mitochondria Function in vivo measured as phosphocreatine recovery rate

    1 weeks

  • Mitochondria Function in vitro measured as maximal oxygen consumption

    1 weeks

  • Body composition

    1 weeks

  • Satelitte cells

    1 weeks

  • Muscle fiber cross-sectional Area

    1 weeks

  • +14 more secondary outcomes

Other Outcomes (4)

  • Blood analysis

    1 week

  • Dairy record registration

    1 week

  • Height

    1 week

  • +1 more other outcomes

Study Arms (2)

Post menopausal women

Pre menopausal women

Eligibility Criteria

Age47 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will primarily be recruited from a radius of 50km from Aarhus. Participants recruited will be age matched to participants in the main trial.

You may qualify if:

  • Regular menstrual bleeding (21-35 days cycle).
  • At least 9 menstrual cycles the last year
  • Age \>47 years old
  • BMI 20-30

You may not qualify if:

  • Only premenopausal women: Follicular stimulating hormone \> 30 mmol/L
  • Systematic strength training during the last year (\> 1 strength training session per week)
  • Systematic high intensity cardiovascular training during the last year (\<2 times 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University

Aarhus, 8000, Denmark

RECRUITING

Related Links

Study Officials

  • Mette Hansen, PhD

    Aarhus University, Department of Public Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mette Hansen, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 27, 2026

First Posted

June 16, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

June 16, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Do to GDPR rules, we do not plan to share

Locations