Menopause-related changes in brain-to-spine motor pathways with hormone therapy
Female Sex Hormone and Menopause Effects on Cortico-reticular Functioning
This project will test whether starting combined hormone replacement therapy changes brain-to-muscle signaling, strength, body composition, and metabolism in women within five years of menopause.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 50 Years to 59 Years |
| Sex | Female |
| Sponsor | University of Jyvaskyla Academic / other |
| Locations | 1 site (Jyväskylä) |
| Trial ID | NCT07500922 on ClinicalTrials.gov |
What this trial studies
Post-menopausal women who plan to begin combined hormone replacement therapy are tested before starting HRT, then again after two months and five months of treatment. Tests include neurophysiological measures of cortico‑reticular/reticulospinal function, strength and physical performance, body composition, resting metabolic rate, and vascular screening. Participants are offered a 12‑week unsupervised exercise program (two strength and two endurance sessions per week) between the 2‑ and 5‑month visits and adherence is recorded. All testing is performed in the morning after an overnight fast at the University of Jyväskylä.
Who should consider this trial
Good fit: Ideal candidates are women at least six months but no more than five years post‑menopause who are willing to start combined HRT, have intact uterus and ovaries from reproductive years, and can attend morning lab visits.
Not a fit: Women with high BMI (>35 kg/m2), active cardiovascular or musculoskeletal disease limiting exercise, smokers, diagnosed psychiatric illness, epilepsy, implanted electronic devices, or other neuromuscular conditions are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the work could clarify whether combined HRT improves neural drive and strength, helping tailor menopause treatment for physical function.
How similar studies have performed: Animal studies and some human work support estrogen's effects on neurotransmission and force production, but direct human cortico‑reticular measurements around HRT are limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * at least 6 months since their last period but no more than being 5 years post-menopausal * basal follicular-stimulating hormone concentration \> 30 IU/L (confirmed post-recruitment) * willing to start combined hormonal treatment * womb and ovaries intact with normal functioning throughout reproductive age * willing to provide informed consent * does not have any of the exclusion criteria for TMS measurements according to Rossi et al. (2021 Clin Neurophysiol. 132(1):269-306.) (i.e. arterial hypertension, heart attack/seizure history, migraine, pacemaker or cochlear implant or other implanted metal/electronic device) Exclusion Criteria: * classified as excessively obese via BMI assessment (i.e., \>35 kg/m2) * intra-uterine device usage during transition to menopause * cardiovascular or skeletomuscular disease preventing strenuous physical activity * smoker * diagnosed psychiatric illness * epilepsy * other diagnosed injuries/illness affecting the neuromuscular system
Where this trial is running
Jyväskylä
- University of Jyväskylä — Jyväskylä, Finland (Recruiting)
Study contacts
- Principal investigator: Simon Walker, PhD — Universirty of Jyväskylä, Finland
- Study coordinator: Simon Walker Dr (Dos.), PhD
- Email: simon.walker@jyu.fi
- Phone: +358408054906
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.